Attachment 4c_LPQ Report

Questionnaire Results:
Survey 2007

DEPARTMENT OF HEALTH & HUMAN SERVICES

HIV-1 Rapid Testing MPEP 2007 Survey Questionnaire Report of Results
Report of the August 2007 Human Immunodeficiency Virus Type 1 (HIV-1) Rapid Testing (RT)
Performance Evaluation Survey Questionnaire Results Provided by Participant Facilities in the
Model Performance Evaluation Program (MPEP), Centers for Disease Control and Prevention
(CDC).

Coordination
of report
production

The production of this report was coordinated in CDC by:
Division of Laboratory Systems…….................... D. Joe Boone, Ph.D., Acting Director
Laboratory Practice Evaluation and
Genomics Branch.................................................Devery Howerton, Ph.D., Chief

Report
content

The material in this report was developed and prepared by:
Model Performance Evaluation Program (MPEP)………..G. David Cross, M.S., Manager
Laurina O. Williams, Ph.D., M.P.H.
MPEP HIV-1 Rapid Testing Performance Evaluation...... Leigh Inge Vaughan, B.A.,
HIV Rapid Testing Project Coordinator
MPEP acknowledges the contributions of Courtney Rodi, B.A., P.M.P. of Constella Group, LLC
for her help in preparing this report.
Use of trade names and commercial sources is for identification only and does not constitute
endorsement by the Public Health Service or the U.S. Department of Health and Human
Services.

Contact
information

Inquiries should be directed to the Model Performance Evaluation Program by calling
Leigh Vaughan at (404) 718-1005 or emailing [email protected].

Summary of Results,
HIV Rapid Testing Survey Questionnaire, August 2007
Purpose

This report details the results from the CDC Model Performance Evaluation Program
(MPEP) HIV Rapid Testing Practices Survey conducted during 2007.

Survey
Description &
Response
Rate

The HIV Rapid Testing Practices survey consisted of 22 multiple part questions.

Survey
Participants

Data was collected regarding the survey participants, including: type of facility, areas of
specimen collection & testing, as well as personnel experience & training
• Facility types (as self-identified in the survey and shown in Figure 1a) included:
o 45% (144/319) hospital laboratories.
o 41% (131/319) non-traditional or outreach testing sites, i.e. sites other
than hospitals, HMOs, health departments, independent laboratories,
reference laboratories, or blood banks.
• For U.S. sites, these were primarily community based
organizations (34/125), family planning centers (28/125), and HIV
counseling & testing sites (24/125).
• For non-U.S. sites, 24% (6/25) could be considered non-traditional
sites, and included embassy health unit labs (2/6), and one each
non-governmental organization, HIV counseling & testing site,
physician’s office and sexually transmitted disease clinic.
o There was an increase in proportion of family planning centers in the U.S.
(10%; 28/294), as compared to the previous survey (<1%; 2/318).

The questions covered topics over a variety of subjects related to HIV rapid testing,
including:
o testing practices,
o testing site demographics
o personnel,
o quality assurance issues
• The survey was sent to all testing sites enrolled as of August 2007 in the MPEP
HIV rapid (HIV-RT) testing program.
• Response rate: 46% (320/701), which included:
o 295 U.S. testing sites and
o 25 non-U.S. testing sites.
• Comparison to previous HIV Rapid Testing Questionnaire Survey (August 2005):
o The distribution of respondents with respect to facility types compared
with non-respondents was consistent across testing site types.
o The number of participants who were mailed the current survey (701) was
about a third greater than in the previous survey (520).
o The response rate (46%) was lower than the previous survey (68%). This
could be due to new sites being unfamiliar with the questionnaire process,
or technical difficulties experienced with using the MPEP result website.

continued next page

1

Survey
Participants,
continued

Summary of Results, continued
•

•

•

Purpose of
Testing

Results for on-site and off-site specimen collection and testing locations
(Figure 7d) showed a variety of off-site locations, including:
o CBOs (community-based organizations),
o counseling and testing sites,
o correctional facilities and
o drug treatment centers.
Testing personnel data is shown in Figure 10. Persons performing HIV rapid
tests were primarily:
o medical technologists,
o medical technicians,
o HIV counselors,
o persons with a BS/BA in a relevant science, and
o persons with an associate’s degree.
Training for HIV rapid tests is shown in graphs and tables 11a-d. The top three
responses regarding type of training were:
o 45% (220/488) in-house training,
o 26% (127/488) required to pass a performance evaluation (PE) sample
panel, and
o 16% (79/488) state health department training.

Survey questions collected information regarding HIV rapid testing purposes, target
populations, and the cost of testing to the client/patient.
“Purpose of HIV rapid testing” data is shown in Figure and Tables 2a. In addition
to the data shown, an analysis by facility type showed the following:
• Hospitals and health departments indicated that HIV rapid testing was being
used for different purposes, including:
o post-exposure treatment,
o testing pregnant women,
o voluntary HIV testing, and
o initial screening for diagnosis.
• Other facility types primarily indicated that HIV rapid testing was used for:
o voluntary HIV testing,
o testing all clients/patients seen in the facility, and
o initial screening for diagnosis.

Target
Population

Target population data is shown in Figures 2b and 2c. Participants were asked to
note if they targeted any particular group for HIV rapid testing.
• Twenty-seven percent (80/291) of the sites selected a “high risk” target population, of
these, 71 further identified one or more “high risk” categories for a total of 295
responses. The top three “high risk” response categories were:
o gay/bisexual men or men who have sex with men (20%; 58/295),
o injection drug users (20%; 58/295), and
o high-risk women (e.g. sex workers (18%; 53/295).
• Approximately half of the respondents (52%; 151/291) had no specific target
population, i.e. they offered HIV rapid testing to the general population they serve.
The majority of these testing sites (data not shown) were hospitals (72%; 109/151).
continued next page
2

Summary of Results, continued
Cost Reimbursement

Cost reimbursement is described in Figure 21(a) and 21(b). Participants were
asked to provide the approximate amount (in U.S. dollars) they charge to perform an
HIV rapid test.
• Over half of respondents (57%, 132/232) indicated no charge for performing
HIV rapid tests.
• Thirty-eight percent (87/232) of the responding sites indicated that they
charge amounts in excess of $20.00. Of these,
o 28% (24/87) charge between $21 and $50,
o 46% (40/87) charge between $51 and $100, and
o 26% (23/87) charge over $100.
• These were all U.S. sites
• The sites were primarily hospitals (18/23) with the others being one
each health department, blood bank, independent lab, community
based organization and physician’s office.

HIV Rapid
Test Kits
Used

HIV testing information includes the manufacturers and kit types selected by
participants, as well as testing volume & result data.
HIV rapid test kits used by participants are shown in Figure 5, with 346 responses
for kit type reported by 295 testing sites. Note: sites could select more than one kit
type.
• The predominant kits reported by U.S. testing facilities were
o OraQuick ADVANCE Rapid HIV-1/2 Ab tests (61%, 182/300),
o Trinity Biotech Uni-Gold Recombigen HIV tests (15%, 46/300), and
o MedMira Reveal G3 Rapid HIV-1 Ab tests (13%, 39/300).
• The predominant kit type reported by non-U.S. testing sites was
Abbott Determine HIV-1/2 (74%, 17/23)
Note: a variety of kit types were reported by these testing facilities.
Nearly half (47%; 141/298) of the sites currently performing HIV rapid testing reported
performing HIV tests other than rapid tests in their facilities. Sites could select more than
one non-rapid HIV test response, and the majority of the 160 responses were made by:
• hospitals (39%; 63/160) and
• health departments (28%; 45/160) (Figure 8).

continued next page

3

Summary of Results, continued
Test Volume
& Results

For test volume and result data, see Figures 3b and 3c.
• The median number of HIV rapid tests performed in the most recent
representative month calculated from the responses was 25,
(range = 0 to 1400),
o The highest volume sites are non-U.S. facilities, including the three sites
reporting that they perform 1000 or more tests/month.
• A relatively high percentage of alternative* sites, family planning centers and
counseling and testing sites performed 100 tests or more during the most recent
month: 38% (5/13), 44% (4/9), and 48% (15/31), respectively).
• Most of the U.S. testing sites (66%; 173/263) reported that none of the HIV rapid
tests performed on client/patient specimens in the most recent representative
month was initially reactive (preliminary positive)
* Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile units.

Confirmatory
Testing

Quality
Control

Confirmatory testing practices are depicted in Figures 12a through 12f.
• Most participants (93%; 272/291) reported that confirmatory testing was
performed either within their facility or at another facility on initially reactive
(preliminary positive) results,
o specific testing algorithms are depicted in tables
12b and 12c.
•

7% (19/291) answered “no” to this question, implying that no confirmatory
testing was performed.

•

8% (18/231) of U.S. testing sites describing methods used for confirmatory
testing did not use either Western blot (WB) or an indirect
immunofluorescence assay (IFA), the confirmatory methods recommended by
current CDC guidelines.1, 2

Quality Control (QC) practices and sources of QC material are shown in the
figures and tables 19a through 19b.
• 97% of the responses (1043/1072) indicated that external quality control
samples (not included in the test kit) were run when performing HIV rapid
testing.
o This was the same proportion as the responses given in the previous
(2005) survey (97%; 1172/1214).
o Participants could give more than one response.
•

3% of the responses (29/1072) indicated that external quality control samples
(not included in the test kit) were never run, although it should be noted that
most of these sites reported using test kits that had quality control material
included in the kit.
o Most of these were U.S. testing sites.
o Testing QC samples as a part of an overall quality assurance system
is recommended. 1
continued next page
4

Summary of Results, continued
Privacy
Issues

Testing
turn around
time

Privacy issues (Figure 4a/b) were examined by asking sites if they provided anonymous
HIV rapid testing or had confidentiality procedures.
• Less than half (42%; 120/289) of the testing sites that answered the question
responded that they provide anonymous testing, while
• Nearly 100% (99%; 286/289) responded that they do protect the confidentiality
of the client/patient being tested for HIV.

The time from specimen collection to the results being given to the client/patient are
depicted in the figures and tables for 13a & 13b, for both reactive (preliminary positive) and
negative results.
• Reactive HIV rapid test reporting times included responses from 287 testing sites:
o Most sites reported results in 1 hour or less (66%, 190/287).
o Some (14%, 40/287) reported results between 1 to 3 hours.
o A few (4%, 11/287) reported times of 24 hours or less.
o Other sites (7%, 20/287) reported times between 25 and 76 hours.
o The remaining sites (9%, 26/287) reported other time periods.
•

Same day
result
reporting

Negative HIV rapid test reporting times included responses from 290 testing sites:
o Most sites reported results in 1 hour or less (72%, 210/290).
o Some (12%, 36/290) reported results between 1 to 3 hours.
o Other sites (7%, 20/290) reported times of 24 hours or less.
o A few (4%, 11/290) reported times between 25 and 76 hours.
o The remaining sites (4%, 13/290) reported other time periods.

Reporting of results within one day was examined for both reactive and negative HIV rapid
test results in tables 14a-e through tables 15 a-e.
• A large majority of testing sites responding to the question (69%; 203/293) reported
they give results of initially reactive (preliminary positive) HIV rapid test results the
same day as testing;
o virtually all of these sites (99%; 201/203) also give negative test results the
same day as testing.
• Of those labs that do NOT give the results of initially reactive (preliminary positive)
HIV rapid test results the same day, about half (51%; 31/61) also did not report
results of negative results the same day.
o This appeared consistent over type of facility.

continued next page
5

Summary of Results, continued
Additional
comments

The CDC HIV-RT MPEP supports improving the quality of public health by
continuously improving laboratory testing. CDC HIV-RT MPEP will continue to
monitor laboratory practices in HIV rapid testing.
The results presented here reflect a wide range of laboratory/testing site practices in
HIV rapid testing among MPEP participants. With changing and evolving testing
practices, HIV testing sites should be especially concerned about quality assurance,
and should be aware of existing guidelines and recommendations.
1) Recommendations for an overall quality assurance program for HIV rapid
testing sites and for good laboratory practices can be found on the MPEP
website: http://wwwn.cdc.gov/mpep/default.aspx
2) Recommendations for good laboratory practices for sites performing waived
tests have recently been published by CDC and can be accessed at :
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm
3) This and other links to useful information about HIV rapid testing, as well as
other HIV testing issues, can be found at:
o http://www.cdc.gov/hiv/topics/testing/rapid/index.htm and
o http://www.cdc.gov/hiv/topics/testing/guideline.htm

References

1) Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived
Under the Clinical Laboratory Improvement Amendments of 1988:
http://www.cdc.gov/hiv/topics/testing/resources/guidelines/qa_guide.htm
2) CDC. Notice to Readers: Protocols for Confirmation of Reactive Rapid HIV Tests,
MMWR Recommendations and Reports. 2004: 53(10); 221- 222.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5310a7.htm
3) CDC. Good Laboratory Practices for Waived Testing Sites, MMWR
Recommendations and Reports. 2005: 54(RR13); 1-25.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm
Note: Use of trade names is for identification only and does not imply endorsement by the
Centers for Disease Control and Prevention

6

The following graphs and tables reference the number of facilities (n) and/or the number of
responses (N) relative to each question.
1.a) Please indicate the primary classification of your facility/testing site
(Check one primary classification).
Note: 319/320 sites self-identified their facility in response to this question, as indicated in the
following graphs. One U.S. site did not respond to the question.

Primary Type of U.S. Testing Site
Hospital

141 (48%)

Community based org.

34 (12%)

Family planning center

(n=294 testing sites)

28 (10%)

HIV counseling & testing site

24 (8%)

Health department

23 (8%)

Physician's office

14 (5%)

Sexually transmitted disease clinic

9 (3%)

Drug use treatment center

6 (2%)

Independent lab

4 (1%)

Correctional facility

4 (1%)

Community clinic/health ctr

2 (1%)

Other*

5 (2%)
0

20

40

60

80

100

120

140

160

180

200

Number of Testing Sites
Primary Type of Non-U.S. Testing Site
5 (20%)

Health department
Independent lab

4 (16%)

Hospital

3 (12%)

Research & reference lab

3 (12%)

Blood/Plasma donor center

2 (8%)

Embassy health unit lab

2 (8%)

National reference center

2 (8%)

(n=25 testing sites)

Other*

4 (16%)
0

1

2

3

4

5

6

7

8

9

10

11

Number of Testing Sites

12

13

14

15

1

1.a) continued;
*The “Other” testing sites referred to in this questions included one each of the following:
• U.S. sites
o health maintenance organization
o clinic & field testing
o Native American health clinic
o health lab
o university health center
• Non-U.S. sites
o NGO (non-governmental organization)
o HIV counseling & testing site
o physician’s office
o sexually transmitted disease clinic

The following graph refers to those sites self-identifying as “Hospital” specifically
to indicate all applicable sections/location within the hospital:
Note: The responses are grouped into the most commonly specified combinations of sections.
One of the three non-U.S. hospital sites identified in question 1a did not specify a hospital section.
Testing Sites Within Hospitals
85

Central lab only

Number of Response Patterns

Admis sions and one or more locations

29

1

Emergency room and one or more locations

8

Blood bank only

7
4

Employee health and one or more locations
Other only

1

3

Emergency room only

2

Employee healt h only

1

Blood bank, central lab

1

Central lab, ward f loor

1

n=143 hospitals (143 response patterns)
(N=339 total responses )
U.S., n=141

0

Non-U.S., n=2

10

20

30

40

50

60

70

80

90

Number of Testing Sites

2

1.b) Which of the following services does your organization provide?
(Check all that apply).

Top 5 Serv ices Provided by Top 5 U.S. a nd Non-U.S. Fa cility Types
19

HI V ct s ite*

n=312 testing sites

5
6
27

Health department

Facility Type

N=737 responses

30

11

11
12

STD treatment/prevention

31

HIV/ AI DS prevention & educ ation

5
26

Family planning c enter

Medic al care for people with
HIV/ AI DS
Maternal and child health

9

5

17

CBO*

30

Comprehens ive/general health
treat ment

29

14

6

14
85

60

Hos pital

1 13
81

0

20

40

60

91

80

10 0

12 0

Number of Respons es
* HIV ct sit e = HIV counseling and testing sit e
CBO = community based organization

Top 5 Serv ices Prov ided by All U.S. and Non-U.S. Facilities

195

STD
treatment/prevent ion

11

193

Services

HIV/AI DS prevention &
educ ation

13

163

Medic al care f or people
with HIV/AIDS

10

131

Maternal and c hild health

7

N=857 respons es
n=318 testing sites

U.S., N=812, n=294
Non-U.S., N=45, n=2 4

130

Comprehensive/ general
health t reatment

4
0

50

100

150

Number of Responses

200

250

3

1.c) Does your facility currently perform HIV rapid testing?

Response

Number of Facilities (%)
(n=320)

Yes

298 (93.1%)

No*

22 (6.9%)

*These facilities were omitted from analyses regarding current testing practices
1.d) If your facility does not perform HIV rapid testing, why not?
(Check all that apply).
Of the 22 facilities that do not currently perform HIV rapid testing, 10 plan to start in the near future.

1.e) When did your facility begin to perform HIV rapid testing?
160
145

n=274 testing sites

140

Number of Responses

120

100

80

60
41
32

40
19

16

13

20
8

0
0-6 mo

7-12 mo

1 yr

2 yr

3 yr

4 yr

5+ yr

Length of Tim e Performing Rapid Testing
Note: 24 sites responded that the starting dates were unknown or provided no inf ormation
about the starting date.

4

2.a) For what purpose(s) do you offer HIV rapid testing? (Check all that apply)
300

N=647 responses
Number of Responses

250

200

n =196 testing sites
179 (28%)
159 (25%)

150

100

88 (14%)

83 (13%)
56 (9%)

50

34 (5%)

24 (4%)

24 (4%)

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Of facilities indicating two purposes for testing, the top 3 combinations of answers for question
2a are shown in the table below:
Combination of responses
Testing pregnant women & post-exposure treatment
Initial screen for diagnosis & voluntary HIV testing
All patients/clients & voluntary HIV testing
Total

Number of response
combinations
29
19
15
63

*Other HIV rapid testing purposes include:
Purpose for Testing
Research/QA/manufacturing/clinical trials
As part of high-risk or STD exam
Blood donor/transplant (screening)
Premarital/visa/other license
Upon doctor's request
HIV-1 vs. HIV-2 differentiation
Patient/client is afraid of venipuncture
Mandatory for clients in harm-risk-reduction program
Patient incentive program
New employees

Responses
6
5
3
3
2
1
1
1
1
1

5

2.b) What is the primary target population for your rapid testing program?
(Check only one).
High risk group?
(Y/N)
Y
Y
N
N
N

Primary target population
Any high risk client/patient
Only certain types or categories of high risk clients
Any client/patient requesting an HIV test
Any high school/college student
No specific target population

Number of
testing sites
47
33
58
2
151

Risk Categories

Of the 291 sites that answered the question, 80 reported a “high risk” group as their target
population (see table above). 71/80 of these sites further defined their “high risk” group by
selecting specific target high-risk categories (see graph below).

Gay/b isexua l m e n o r
M SM *

58

I njec tio n d rug use rs

58

H igh -ris k w o me n (e .g.
sex w orkers)

53

H is pa nic/L atino

31

A frican A m ericans

30

H om e le ss

29

Ad ole sce nts

N= 29 5 respo nses

20

n= 71 t esting sit es
16

Othe r
0

10

20

30

40

50

60

70

Nu m ber o f Re spo nses

*MSM: men who have sex with men

The following describes the responses for “Other” in the above graph:
• partner of other high risk person (partner is HIV positive, MSM, sex worker,
injection drug user, etc), N=6
• transgender community, N=4
• non-injection drug users, sexual assault survivor, or mentally ill, N=3
• inmate (adult or juvenile) N=2
• babies and/or children of HIV positive women, N=1

6

2.c) Approximately how many unique clients does your organization serve per year, across
all programs, onsite and offsite?
Numbe r of Unique Clients Served Each Year
60

50

n=185 testing sites

50

U.S., n=165

Number of Testing Sites

Non-U.S., n=20

42
39

40
34
30

20

10

6

5

4

5

0
1-100

101-1,000

1,001-5,000

>5,000

Number of Unique Clients

7

2.d) (U.S. sites only) Approximately what percentage of clients/patients seen in your
organization have the ethnic backgrounds indicated?
Note: see third graph (on next page) for depiction of answer selections “Unknown”
70
N=291 responses

64

n=104 testing sites

60

White/Caucasian
Hispanic or Latino
African American

52

Number of Responses

50

40

30
25
21

20

19

21

19
16

14

13

10
1

7

5

3

6
3

2

0
0%

1-20%

21-40%

41-60%

61-80%

81-100%

Percentage of Client/Patients

Note: Some major ethnic groups were not included in the answer options for the above graph,
including Pacific Islander, Asian and Native American.

(U.S. sites only) Approximately what percentage of client/patients seen in your organization: 1)
are of HIV-positive status and 2) have incomes at or below the Federal poverty level?
70

70

60

60

65

Number of Testing Sites

50

Below federal poverty line (n=65 testing sites)

50

HIV positive (n=85 testing sites)

40

40

30

30

22

20
10

8

10

20
20

10

9

4

4

4

21-40%

41-60%

3

1

0

0

0%

1-20%

21-40%

41-60%

61-80% 81-100% 0%

Percentage of Client/Patients

1-20%

61-80% 81-100%

Percentage of Client/Patients

8

2.d) continued;
All of the 279 sites that answered question 2d regarding demographic data answered “unknown” to
one or more of the demographic categories, therefore all responding sites were missing some or all of
the demographic data.
• 134 sites answered “unknown” to one or more (but not all) of the options and
• 145 sites answered “unknown” to all of the options.

2.e) Who PRIMARILY funds your testing site? (Check only ONE BEST answer).
90

Private, non-profit

1

53

State funded

6

County, c ity or other
government

34
4

27

CDC funded

U.S., n=249

2

Non-U.S., n=21
20

Private, for profit

2
12

Federal, other than CDC

4

n =270 testing sites

13

Other

2
0

10

20

30

40

50

60

70

80

90

100

Number of Testing Sites

9

135
39
6
9
8
32
31
10
13
9

Health department

Independent

Family planning center

Physician's office

Community based org.

Counseling & testing site

Other

Alternative site*

Blood bank

Number of
Sites

Hospital

Facility Type

5 (56%)

1 (8%)

2 (6%)

2 (25%)

1 (11%)

3 (50%)

10 (26%)

60 (44%)

≤10% rapid tests

2 (22%)

3 (23%)

3 (30%)

4 (13%)

6 (19%)

2 (22%)

12 (31%)

14 (10%)

1 (11%)

3 (23%)

2 (20%)

9 (29%)

10 (31%)

2 (25%)

4 (44%)

2 (33%)

8 (21%)

3 (2%)

11-74% rapid tests 75-99% rapid tests

1 (11%)

6 (46%)

5 (50%)

16 (52%)

16 (50%)

4 (50%)

2 (22%)

1 (17%)

9 (23%)

58 (43%)

100% rapid tests

Percent of HIV testing performed using rapid HIV test kits, by facility type

3.a) Of all HIV testing performed in your facility over the past year, what percentage
was performed using HIV rapid test kits?

The table below breaks out the percent of HIV testing performed using HIV test kits
by the type of facility.

Note: The percentages (rounded to the nearest whole number) are based on the number (n) of each facility type that
answered the question.

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

10

3.b) How many client/patient specimens were tested using HIV rapid tests in your facility
during the most recent representative MONTH?
61

0-4 (about <1/week)

6
28

Number of Client/Patient Specimens

5-8 (about 1-2/week)

42

9-20 (about 2-5/week)

2
33

21-40 (about 5-10/week)

3

41-60 (about 11-20/week)

3

24

12

61-80

1
10

81-100

25

101-199

U.S., n=267
15

200-299

Non-U.S. , n=23

2

n=290 testing si tes

17

>299

6

0

10

20

30

40

50

60

70

Number of T esting Sites

The table below shows the number of specimens tested in the most recent representative month
broken out by type of facility.
Note: The percentages are based on the number (n) of each testing facility type that answered the
question.
Number of Specimens Tested in the Most Recent Month
≤30 HIV RT/representative
31-99 HIV RT/representative
≥100 HIV RT/representative
month
month
month

Facility Type

Number of
Sites

Hospital

135

102 (76%)

19 (14%)

14 (10%)

Health department

38

13 (34%)

11 (29%)

14 (37%)

Independent

6

4 (67%)

1 (17%)

1 (17%)

Physician's office
Community based org.
(CBO)

8

4 (50%)

2 (25%)

2 (25%)

31

14 (45%)

9 (29%)

8 (26%)

Other

10

5 (50%)

2 (20%)

3 (30%)

Family planning center

9

2 (22%)

3 (33%)

4 (44%)

Alternative site*

13

2 (15%)

6 (46%)

5 (38%)

Blood bank
Counseling and testing
center

9

5 (55%)

1 (11%)

3 (33%)

31

10 (32%)

6 (19%)

15 (48%)

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

11

3.c) Of the specimens reported in question 3b above, how many were initially reactive
(preliminary positive) during the same most recent representative MONTH?
200
180

173

Number of Testing Sites

160
140

n =285 testing sites

120

U.S., n=263
Non-U.S., n=22

100
76

80
60
40
20
5

4

4

6

3

0
0

1 -5

6 - 10

4

2

11 - 20

5

3

21 - 40

41-181

Fre quency of Reactive Tests per Month

The following graph depicts the calculated percentage of initially reactive HIV rapid tests
performed in the most recent representative month.
Note: this graph is based on data from sites that also answered question 3b
(the number of HIV rapid tests performed)
200
n=280 testing sites
180

175

U.S., n=259
Non. U.S., n=21

Numbe r of Testing Sites

160
140
120
100
80
62

60
40
20

10
4

2

4

1- 5

6 - 10

8

4

2

6

0
0

11 - 25

26 - 50

2

1

51 - 100

Percent Initially Reactive in Most Recent Representative Month

12

3.d) Of the above (see question 3c) initially reactive (preliminary positive) HIV rapid test
results for which a confirmatory test was performed, how many were confirmed
positive?
Note: the table below describes percentages based on the answers provided for question 3c.
Facility type
Hospital
Health department
HIV counseling and testing site
Community based organization
Alternative sites*
Other
Blood bank
Family planning center
Total

0-20
3
1
1

5

Percent confirmed positive
21-40
41-60
61-80
1
1
1
2
1
2
1
1
1
1

3

1
7

3

81-100
20
18
13
12
6
2
1
72

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

41 testing sites answered the question as follows: we have not had any reactive
(preliminary positive) HIV rapid test results, n=34; we do not perform confirmatory testing, n=6;
not applicable (N/A) - the client/patient is referred elsewhere for confirmatory testing
(the results are unknown), n=1.
Over half of the reporting testing sites currently performing HIV rapid testing, (167/298; 56%)
did not answer the above question; this may be due to lack of information or understanding
regarding confirmatory test results.

13

3.e) In the last 6 months, how many persons received preliminary positive results,
but did not return for confirmatory test results?
The following graph gives the percent of U.S. clients/patients who did NOT return for their
confirmatory test results.
Note: this graph is based on data from those U.S. sites who answered both parts of question 3e,
i.e. sites that gave data for the number of persons with initially reactive HIV rapid testing results and
also gave data for the total number of persons not returning for confirmatory results.
50
47
45

(n=75)

40

Num ber of Testing Sites

35
30
25
20
15
11
10
6
5

4

4

41-60%

61-80%

3

0

0%

1-20%

21-40%

81-99%

Per cent of Per son s NOT Retur ning for Confirmatory Testing Results

There were 11 U.S. sites that reported 100% of their clients/patients did not return for confirmatory
test results in the last six months; these sites are listed by type of facility in the table below.
Facility type

100% of persons NOT returning for
confirmatory results

Hospital

4

Community based organization

3

Health department

2

Alternative sites*

2

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

The following describes the other selections by 30 U.S. sites:
• we do not require confirmatory testing, n=1
• persons are sent elsewhere for confirmatory testing and we do not receive those results, n=9
• no information available to us on confirmatory testing, n=20
14

3.f) If HIV screening tests other than rapid tests are offered in your facility, what
percentage of patients/clients in the last 6 months with preliminary positive results
[from these other tests] did not return for confirmatory results?

Note: Not all testing sites offer HIV screening tests other than the HIV rapid test method.
Of the 240 sites that answered the question, 95/240 (40%) U.S. and non-U.S. testing sites
had information regarding their clients/patients returning for confirmatory testing results.

The responses given by U.S. sites (n=87), by type of facility, is shown in the table below.
Facility Type
Blood bank
Hospital
Health department
Independent
Family planning center
Alternative sites*
Physician's office
Counseling and testing site
Community based organization
Other
Total

Percent not returning for confirmatory testing
0
1-24
50-69
4
32
2
2
10
2
2
4
4
1
11
2
10
1
78

7

2

The responses given by eight non-US sites were as follows:
• 7/8 indicated 0% clients/patients not returning for confirmatory testing results, and
• 1/8 indicated 1% clients/patients not returning for confirmatory testing results.

“Other responses” given by all sites (n=145) are shown below:
• N/A, other HIV tests are not performed in our facility, n=99 (96 U.S., 3 non-U.S. sites)
• N/A, confirmatory testing is not required for other (not rapid)
HIV screening test(s), n=14 (3 U.S., 11 non-U.S. sites)
• N/A, persons sent elsewhere for confirmatory testing and we do
not receive test results, n=3 (all U.S. sites)
• Don’t know; no information available on confirmatory testing for our
other (not rapid) HIV screening test(s), n=29 (27 U.S., 2 non-U.S. sites)

15

4.a) Does your facility provide anonymous HIV rapid testing?
4.b) Does your facility have procedures for protecting the confidentiality of HIV results?
Less than half (120/289, 42%) of the testing sites answering the question responded that they provide
anonymous testing, while nearly 100% (286/289, 99%) protect the confidentiality of the client/patient
being tested for HIV.

5.) What test kit(s) do you currently use for HIV rapid testing? (Check all that apply).

O raSure OraQuick Advance Rapid HIV 1/2
Antibody Tes t

182

3
46

Trinit y Biotech Uni-Gold Recombigen HIV
MedMira Reveal G3 Rapid HIV-1 Antibody Tes t

39

1

Abbott Determine HIV-1/2

7

Trinity Biotech Uni-Gold HIV

6
8

17

N=346 responses
n=295 testing sites

Trinity Biotech Capillus HIV-1/HIV-2
Chembio HIV 1/2 Stat-Pak (Cass ette)

1

7

U.S., N=300, n=272

6

Non-U.S., N=46, n=23

BioRad Multi-Spot HIV-1/HIV-2

4

MedMira Reveal G2 Rapid HIV-1 Antibody Tes t

3
7
9

Other rapid HIV tes t
0

20

40

60

80

100

120

140

160

180

200

Number of Responses

The following tables outline the “Other” responses to the above question:
U.S. Sites
Other kit responses indicated
Clearview HIV 1/2 Stat-Pak by Inverness Medical
Not Specified

Total
5
2

Non-U.S. Sites
Other kit responses indicated
Immunocomb by PBS Orgenics Hexagon by Human
SD BioLine HIV
Not specified

Total
1
1
7

16

5.) continued;
The graph below shows the type of test kit used by different types of facilities:
OraSure OraQuick ADVANCE Rapid HIV-1
Antibody Test
Trinity Biotech UniGold Recombigen HIV

Oth er

MedMira Reveal G3 Rapid HIV-1 Antibody Test
Co mmunity b ase d org .

Abbott Determine HIV 1/2
Trinity Biotech UniGold HIV

Cou ns elin g and te sting
si te

Trinity Biotech Capillus HIV-1/HIV-2
C hem bio HIV 1/2 Sta-Pak (CASSETTE)

Phy sic ian 's off ice

Other

Facility Type

N=34 6 responses
n=2 95 testi ng sites

A ltern ative s ite s*

Family pla nni ng ce nter

Ind epe nde nt lab

He alth de pa rtmen t

Hos pital

Blood ban k

0

10

20

30

40

50

60

70

80

Number of Responses
* Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

17

6.) What sample type(s) do you currently use for HIV rapid testing? (Check all that apply).
Note: “Serum” and “plasma” responses reflect both fresh and frozen specimens.
Number of sites
(n=294)
49
40
38
31
24
21
20
20
14
10
6
3
3
3
2
2
2
1
1
1
1
1
1

Sample combinations of responses
Serum
Serum, Plasma
Whole blood (venous)
Whole blood (fingerstick)
Oral Fluid
Whole blood (fingerstick), Whole blood (venous)
Whole blood (fingerstick), Oral Fluid
Whole blood (fingerstick), Whole blood (venous), Oral Fluid
Plasma
Serum, Plasma, Whole blood (fingerstick), Whole blood (venous)
Plasma, Whole blood (venous)
Serum, Plasma, Whole blood (fingerstick)
Serum, Plasma, Whole blood (venous)
Whole blood (venous), Oral Fluid
Serum, Whole blood (fingerstick)
Serum, Whole blood (venous)
Serum, Whole blood (fingerstick), Whole blood (venous)
Plasma, Whole blood (fingerstick)
Plasma, Whole blood (fingerstick), Whole blood (venous),,
Serum, Oral Fluid
Serum, Plasma, Oral Fluid
Serum, Plasma, Whole blood (fingerstick), Oral Fluid
Serum, Plasma, Whole blood (venous), Oral Fluid

7.a) Where are specimens collected and HIV rapid testing performed?
Please note: ON-SITE=within your facility; OFF-SITE=outside your facility
180
160

155

n=292 testing sites

Number of Responses

140
120
100
80
60

53

60

40
20

11

8

5

0
Collection and Collec tion on & Collec tion on & Collection off- Collection and Collec tion offoff-site and site and testing testing off-site site and tes ting
testing on-site
off-s ite and
on-site &
on-site
tes ting on &
testing on-site
off-s ite
off-site

18

7.a) continued;

The following graph shows the location of specimen collection by type of facility.
100
n=292 testing sites
90

86

Blood bank
Hospital
Health dept
Independent
Family planning center
Alternative site
Physician's office
Counseling and testing site
Community based organization
Other

Number of Responses

80
70
60
50
41

40
30
20
12

10

5

12
98 9
7
3 4

18 17

15
3

5
1

3

2

5
1

2

1

44

2

11

4

2

121

1

0
Collection and Collection on Collection on Collec tion off- Collec tion and Collection offtesting on-site & off-site and & off-site and
site and
testing off-site
site and
testing on-site testing on & testing on-site
testing on &
off-site
off-s ite

19

7.b) For Hospitals only: In what hospital setting are specimens collected?
(Check all that apply).
7.c) For Hospitals only: In what hospital setting are specimens tested?
(Check all that apply).

140

N=481 responses (specimen collection)
N=161 responses (specimen testing)

120

100

Number of Responses

116

n=139 testing sites

111

Admission
Emergency room (ER)
Employee health/infection control
Blood bank
Labor and delivery
Central laboratory

96
89
82

80

Ward/floor
Other

66
60

40

20

19

15

13
6

3

1

4

13
4

4

0

Setting where specimens a re collecte d

Se tting where spe cimens are tested

“Other” collection in a hospital setting
Hospital Area

“Other” testing in a hospital setting
Hospital Area

Responses

Responses

OR and/or surgery floor

4

Other hospital lab

9

Clinics and other hospital units
Site of employee exposure to potentially
infectious material

4

Clinic

1

3

1

Outpatient draw area

2

Private testing area
Centralized Transfusion Service area
(CTS)

Other hospital lab

2

Not specified

1

Nursing unit/nursing home care

2

All hospital units

1

Neonatal ICU

1

1

20

7.d) Question 7d is ONLY for sites that collect specimens off-site for HIV rapid testing.
If you perform HIV rapid testing on specimens collected off-site (outside your facility),
please indicate where these specimens are collected.
(Check all that apply).
The following graph depicts the specific off-site testing locations.
Note: more than one location could be selected.
Community bas ed organization

40

Drug treatment center

35

Physician's office

35

Mobile unit (not for blood donation)

29

Correctional fac ility

26

Other off-site collection site

25

HIV c ounseling and testing site

21

STD (sexually transmitted diseas e) clinic

16

Health department

12

Offsite hospital/clinic

9

Family planning center

8

Independent lab

7

Community outreach*

6

Medical examiner/coroner's office

6

Miscellaneous public areas **

5

Bar/club

5

Blood/plasma donor center

5
0

5

N=290 responses
n=123 testing sites

10

15

20

25

30

35

40

45

Number of T estin g Sites

* Community outreach includes: shelter, rescue mission, halfway-recovery house, community center,
food-soup kitchen.
** Miscellaneous public areas include: stores, street, needle exchange program, mental health facility,
juvenile detention center, draw stations, retreats.

The table below outlines the responses for “Other” in the above graph:
Category

Responses

Employee health, occupational medicine, or other
occupational exposure area

4

Nursing home/center, extended stay

3

Military (other than hospital)

3

Health fair, "booth", or other public functions/events

2

Church or school

1

Health maintenance organization (HMO)
Misc. multiple combinations of off-site collection
locations

1
11

21

7.e) In which off-site settings does your organization perform rapid HIV tests?
The following table depicts the specific off-site testing locations.
Note: More than one location could be selected and 173 responses indicated “no off-site settings”.

45

N=323 responses
n=245 testing sites

11

No off-site settings

7

In a mobile facility (e.g. van)
19

In stores
173

32

In health fair or other
temporary testing booths*
In bars or clubs
In bathhouses
On the street

7
29

Other setting(s)

*Health fair or other temporary testing booth

The table below outlines the responses for “Other” in the above question:
Category
Correctional facility
Community centers, CBO sites
Other off-site (home, office, race track, retreats, "field followup", counseling service)
Drug treatment center/needle exchange program site
Church or school
Health department/clinic
Sexually transmitted disease (STD) clinic
Shelters/temp housing (e.g. homeless, halfway house)
Unknown/not specified
Misc. multiple combinations of off-site collection locations

Responses
6
6
5
4
3
3
1
1
1
15

22

8.) To detect HIV infection, do you currently perform a test in your facility other than an
HIV rapid test?

The following graph represents “Yes” responses to the question; please note that sites could
select more than one type of non-rapid HIV test.
Note: The one “Other” test kit type in the graph was specified as a “line immunoassay”
by a non-U.S. site listed as an “Independent” facility type.
2

9

Hospital

4

48

2

Health dept

20

1

22

1

Physician's office

1

Blood bank

3

1

N=160 "Yes" re sp onse s
n=141 te sting si tes

5
2

5

CBO*

U.S., N=12 7

3
1
1

Indepe ndent

5
1

Alternative sites**

Non-U.S., N=3 3

NAAT
WB
Other
IFA
EIA/CIA+

NAAT
WB
Other
IFA
EIA/CIA

40

50

2
3

CT site*

1
1

Other

8
4
4

0

10

20

30

60

Number of Responses
*CBO = Community based organization
CT Site = Counseling and testing site
** Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

+ EIA = enzyme-linked immunoassay
CIA= Chemiluminescence assay
NAAT = Nucleic acid amplification test

23

9.) Has HIV rapid testing replaced some other method of HIV testing in your facility?
Please note: This does not refer to changing to another HIV rapid test method.
In answer to the question, 86% said they did not replace and 13% said they did replace another method
of HIV testing with HIV rapid testing. Of those who said “Yes”, the following table specifies their
responses.
Note: sites could select more than one HIV test, e.g. HIV rapid testing might have replaced both
EIA and Western blot HIV tests.
Specified "Yes" responses

Responses

EIA
OraSure EIA
Abbott (not specified)
Biorad Genetic Systems
Unknown
Not specified
BioMerieux Vironostika
Genscreen HIV-1/2 v.2
Sanofi
SUDS
Syra
Other
OraSure oral fluid
Oral fluid test (not specified)
Not specified
Western blot
OraSure western blot
Bioline
HIV Blot 2.2
Not specified

6
5
4
2
2
1
1
1
1
1
6
2
1
2
1
1
1

24

10.) Who performs HIV rapid testing in your facility on a regular basis?
(Check all that apply).
Medic al tec hnologis t

176

Medical technic ian

108

HIV counselor

94

Person with BS/BA in relevant science

70

Person with associates degree

N=695 responses

57

Nurse (RN/LPN)

n=290 testing sites

37

Phlebotomis t

29

High school graduate

27

Medical assistant

21

Nurs e practitioner

19

Pers on with MS/PhD in med./lab science

14

Volunteer with formal medical training

13

Volunteer wit h no formal t raining

5

Physician assistant

5

O ther trained soc ial worker or health care assistant

5

Other higher educational degrees

4

Site coordinator, director, or adminis trator

4

Physic ian

4

Other staff

3
0

20

40

60

80

100

120

140

Number of Testing Sites

160

180

200

25

11.a) How many staff in your organization are trained to do HIV rapid tests?
277 sites answered the question; both U.S. (258 sites) and non-U.S (19 sites) reported varying
numbers of personnel were trained to do HIV rapid testing.

11.b) What type of training is required for personnel performing HIV rapid testing in your
facility/testing site? (Check all that apply).
In-house

207

13

Pass a PE sample panel

5

State health department

3

By kit manufacturer

2

NRL*, workshop, & "other training"

1

122
76

29

6

6

Ongoing competency/proficiency evaluations
Course by CDC

4
2

Initial observation/evaluation by other person(s) to
demonstrate competency

5

Training in counseling

3

U.S., N=460, n=265
Non-U.S., N=28, n=23

No training required

2

Local health department training

1

Read SOP (standard operating procedures)

1

0

N=488 responses
n=288 test ing sites

50

100

1 50

2 00

250

Number of Responses

* NRL = National Reference Laboratory

26

11.c) What is covered in the HIV RT training? (Check all that apply).
Number of responses for material(s) covered in training
Reading
package
insert

Practice
test

Standard
operating
procedures
(SOP)

External
Quality
Assessment
(EQA)

Quality
control
issues

Quality
assurance

Counseling

Hospital
(n=131)

106

113

115

98

117

7

1

Health department
(n=38)

34

34

38

31

36

4

1

Community based
organization (CBO)
(n=31)

29

31

31

24

29

1

2

HIV counseling and
testing site
(n=30)

27

28

28

28

30

3

2

Other facility type
(n=7)

7

7

7

6

7

Physician's office
(n=8)

8

8

8

6

8

Blood bank
(n=9)

8

8

9

8

8

7

5

6

4

6

10

9

10

3

8

Alternative sites*
(n=12)

12

12

12

11

11

Totals

248

255

264

219

260

Facility type
(n=283 respondents)

Independent laboratory
(n=7)
Family planning center
(n=10)

2

17

6

* Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit
Most Frequent Combinations of Answers for 11c
Combination
Reading package insert, practice
test, external QA and QC issues
Reading package insert, practice
test, SOP, and QC issues
Reading package insert, Practice
test, SOP, external QA, QC issues
and other

Number of
% Sites
testing sites (out of 283 sites)

161

57

28

10

12

4

27

11.d) Is there a ‘site-specific’ Standard Operating Procedure (SOP) manual for
rapid testing at the testing site?

Facility type
(n=289 testing sites)

Yes

No

Hospital
(n=132)

128 (97%)

4

Health department
(n=39)

39 (100%)

0

Community based
organization (CBO)
(n=32)

31 (97%)

1

HIV counseling and
testing site
(n=30)

28 (93%)

2

Alternative sites*
(n=12)

12 (100%)

0

Family planning center
(n=10)

9 (90%)

1

Other facility type
(n=10)

10 (100%)

0

Blood bank
(n=9)

9 (100%)

0

Physician's office
(n=8)

7 (88%)

1

Independent lab
(n=7)

6 (86%)

1

279 (97%)

10

Totals

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

28

12.a) Is confirmatory testing performed (either in your facility or another facility) on
initially reactive (preliminary positive) HIV rapid tests?
Facility type (n=291)

Yes

No

Hospital (n=134)

124 (93%)

10 (7%)

Health department (n=38)

35 (92%)

3 (8%)

Community based organization (n=32)

30 (94%)

2 (6%)

HIV counseling and testing site (n=30)

29 (97%)

1 (3%)

Alternative sites* (n=13)

13 (100%)

Family planning center (n=10)

10 (100%)

Other (n=10)

10 (100%)

Blood bank (n=9)

9 (100%)

Physician's office (n=8)

7 (88%)

1 (12%)

Independent laboratory (n=7)

5 (71%)

2 (29%)

272 (93%)

19 (7%)

Total

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

29

12.b) Many laboratories/testing sites use multiple tests simultaneously or in a
step-wise fashion to derive an initial (preliminary positive) result and/or
a confirmed result.
What is the typical algorithm, or order of tests, you use for HIV rapid testing
and confirmatory testing?
Note: All algorithms with three or more responses are defined in the table below; the remaining
algorithms are listed as “Other algorithms” with the exception of the “RT, RT, RT” response, which is
included in the table below with one response.
Algorithms for HIV Rapid Testing
Step 1

Step 2

Step 3

Step 4

Step 5
U.S. sites
(n=231)
67

Responses
Non-U.S.
Total (% sites)
sites
(n=248)
(n=17)

RT

WB

RT

EIA

WB

58

58 (23%)

RT

RT/RT*

WB

27

27 (11%)

RT

RT/RT

EIA

15

15 (6%)

RT

RT

WB

13

13 (5%)

RT

RT/RT

EIA

WB

8

RT

RT

EIA

WB

6

RT

RT/RT

EIA

RT

EIA

WB

IFA

2
IFA

RT
RT

EIA

WB

RT

RT

RT

NAAT

Other algorithms

2

2

69 (28%)

10 (4%)
6 (2%)

3

4

5 (2%)
4 (2%)

1

2

3 (1%)

2

1

3 (1%)

1
27

1 (<1%)
7

34 (14%)

*RT/RT = two rapid tests performed simultaneously

The question defined “Step 1” as the initial HIV rapid test performed by the site.
30

12.c) Please complete the table below to show the algorithm you use when the secondary or
confirmatory test results are indeterminate (IND) AFTER an initially reactive
(preliminary positive) result. What is the typical algorithm you use in your
laboratory/testing site for HIV rapid testing and confirmatory testing?
Note: All algorithms with three or more responses are defined in the table below; the remaining
algorithms are listed as “Other algorithms.”
Algorithms for HIV Rapid Testing
Step 1

Step 2

Step 3

Step 4

Step 5

RT

EIA

WB

RT

WB

RT

RT/RT*

WB

RT

RT/RT

EIA

RT

RT

WB

10

RT

WB

WB

7

RT

RT

EIA

WB

RT

RT/RT

EIA

IFA

RT

EIA

RT

EIA

WB

RT

WB

Other**

5

5 (2%)

RT

WB

NAAT

4

4 (2%)

RT

RT/RT

RT/RT

4

4 (2%)

RT

RT/RT

Responses
Non-U.S.
U.S. sites
Total (% sites)
sites
(n=218)
(n=235)
(n=17)
39
34

39 (17%)
1

14
WB

9

WB&NAAT

NAAT

RT

14 (6%)
2

11 (5%)
10 (4%)

2

9 (4%)

8

8 (3%)

8

8 (3%)

7

7 (3%)

5

WB

35 (15%)

1

6 (3%)

3

1

4 (2%)

3

1

4 (2%)

RT

EIA

WB

Other***

RT

RT/RT

RT/RT

EIA

RT

EIA

EIA

WB

1

RT

WB

RT/RT

WB

3

3 (1%)

RT

WB

RT

WB

3

3 (1%)

NAAT

Other algorithms

3

3 (1%)

3

3 (1%)

45

2

7

3 (1%)

52 (22%)

*RT/RT = two rapid tests performed simultaneously
** The “Other” tests were HIV-2 (N=2) and “not specified” (N=1)
***The “Other” tests were not specified (N=3)

The question defined “Step 1” as the initial HIV rapid test performed by the site.
31

12.d) What specimen type do you use to confirm initially reactive HIV rapid test results?
(Check all that apply).
26 (7%)

N=386 responses
n =267 testing sites

92 (24%)
162 (42%)

Serum
Plasma
Whole blood, fingerstick

1 (<1%)

Dried blood s pot
Whole blood, venous

30 (8 %)

Oral fluid

75 (19%)

Note: One testing site specified “urine” as a confirmatory specimen.
12.e) Which of the following procedures are used to obtain a specimen for a confirmatory
test?
2 0 (6%)

4 (1%)

160 (46%)
N=350 responses
n=266 testing sites
1 66 (47%)
Prior blood draw
New blood draw
Ora l fluid
Unknown

Note: One testing site specified “urine” as a procedure used to obtain a confirmatory specimen.
32

NOTE: The following three questions (12f-12h) refer to specimens which give an INITIALLY
negative or indeterminate rapid test result.
12.f) If the initial HIV rapid test result is negative or indeterminate, is further HIV testing
performed for that client/patient (either in your facility or another facility)?
Hospital

64

Health department

Type of Facility

21

16

Community based
organization (CBO)

19

13

HIV c ounseling &
tes ting s ite

16
14

Alternative sit es*

2

Family planning center

2

n=283 tes ting sites
Yes, (n=156)

10

No, (n=127)

8

Blood bank

5
4

Other

5
4
2

Physician's office

67

5
3
3

Independent lab
0

10

20

30

40

50

60

70

80

Number of Responses

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit

33

12.g) What specimen type do you use to perform further HIV testing after an initial
negative or indeterminate HIV rapid test result? (Check all that apply).
1 (<1%)
1 (<1%)
13 (6%)
11 (5%)

34 (17%)

91 (44%)
N=205 responses
n=139 testing sites
Serum
Plasma
Whole blood (fingerstick)
Whole blood (venous)
Oral fluid
Dried blood s pot (DBS)
Unknown

54 (26%)

12.h) Please list in a step-wise fashion the steps you take when further HIV testing
specimens which give a negative or indeterminate initial HIV rapid test result, by
placing a number on the line corresponding to the step taken.
Step 1

Step 2

Step 3

RT

RT

RT

RT

RT

EIA

RT

RT

EIA

RT

RT

different RT kit

RT

different RT kit

RT

EIA

different RT kit

RT

RT

EIA

RT

Other Algorithms

Step 4

Step 5

Responses Percentage
(n=158 sites) of responses

EIA

different RT kit

2nd different RT

different RT kit

32

20%

26

16%

37

23%

15

9%

13

8%

11

7%

7

4%

6

4%

11

7%

The question defined “Step 1” as the initial HIV rapid test performed by the site.
34

13.a) On average, how much time passes from collection of the specimen for HIV rapid
testing at your facility until preliminary positive results are reported (given) to the
client/patient? (Check only one).
180
168 (59%)
160

n=287 testing sites

Number of Testing Sites

140

120

100

80

60

40
22 (8%)

22 (8%)

20

20 (7%)

18 (6%)
5 (2%)

6 (2%)

4-8
Ho urs

9-24
Hours

26 (9%)

0

<1 Hour

1 Hour

Be twe en
1 &2
Hours

2-3
Hours

25-72
Hours

Other

The table below outlines the responses for “Other” in the above question:
Category
Don't know/after confirmation
Have not had any preliminary positives
Don't know/tester not responsible for
reporting
Varies with test priority (e.g. STAT vs.
routine)
Other time: (between 72-96 hours:1, one
week:1, one-two week: 1)
Other: n/a (1. We don't report preliminary
positive result, 2. We are a company & don't
have patient specimens)
Not specified

Responses
6
5
5
4
3

2
1

Facility type
25-72 hours between 72-96 hours** one week** one-two week**
Blood bank
1
Hospital
7
Health department
6
1
Physician's office
2
Counseling and testing site
2
1
Alternative sites*
1
Other
2
*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility, drug treatment center & mobile unit ** As
specified in the “Other” option

35

13.b) On average, how much time passes from collection of the specimen for HIV rapid
testing at your facility until negative results are reported (given) to the
client/patient? (Check only one).
70%

185 (64%)
60%

Perc entage of Testing Sites

n=290 testing sites
50%

40%

30%

20%

25 (9%)

10%

19 (7%)

17 (6%)
7 (2%)

13 (4%)

11 (4%)

13 (4%)

9-24
Hour s

25-72
Hours

Other

0%

<1 Hour

1 Hour

Between
1&2
Hour s

2-3
Hours

4-8
Hour s

The table below outlines the responses for “Other” in the above question:
Category

Responses

Varies with test priority (e.g. STAT vs. routine)

8

Unknown: tester not responsible for reporting

3

Other time: (one week:1, one-two week: 1,
72-96 hours: 1; 5 days:1

1

Other: n/a (we are a company and don't have
patient specimens)

1

36

14.a) For Initially Reactive (preliminary positive) HIV rapid test results, is this test result
given the same day to the client/patient (the person whose sample was tested for HIV)?
Of the 293/298 sites currently performing HIV rapid testing that answered the question:
• 203/293 (69%) responded that they reported initially reactive results the same day.
• 61/293 (21%) responded that they do NOT report initially reactive results the same day.
• 29/293 (10%) responded that they did not know.
14.b) If “yes” to part (a): Who gives the result of the HIV rapid test to the client/patient
(the person whose sample was tested for HIV)? (Check all that apply).
Responses
% Responses
(n=203 sites)
109
42%
96
37%
47
18%
3
1%
2
<1%
1
<1%
258

Result Provider
The person who performed the test
The client/patient's doctor or other health care professional
A counselor (who did NOT perform the test)
HIV/program specialist/coordinator
Unknown
Employee health nurse
Total responses

14.c) If “no” to part (a), (Check all that apply).
If initially reactive results are NOT given to the
client/patient on the same day, then:
Responses
(n=56 sites)
Initially reactive HIV rapid test results are NOT reported
directly to the client/patient; they are reported after
confirmation

37

Initially reactive HIV rapid test results are reported to the
client/patient's physician or health care provider

29

Initially reactive HIV rapid test results are reported to
employee/occupational health OR infection control

25

Initially reactive HIV rapid test results are NOT reported to
the client/patient
16
Total responses
107
Note: Of the 61 testing sites that answered “No” to question 14a, five sites gave no response to question 14c.

The sites that selected “Initially reactive HIV rapid test results are NOT reported to the
client/patient” (4th category in above table) are identified by type of facility in the table below:
Facility type
Hospitals
Health department
Community based organization (CBO)
Independent
Physicians office
Other

Responses
11
1
1
1
1
1

37

14.d) Where do the reporting procedures for initially reactive (preliminary positive) HIV
rapid tests occur? (Check all that apply).

Location of reporting procedure
In our facility, in the dept where HIV testing is performed
At another area of our facility (NOT the site where testing is performed)
Externally (NOT at our facility)
Unknown
Total responses

Responses
% Responses
(n=272 sites)
220
74%
48
16%
23
8%
5
2%
296

The sites that selected “Externally (NOT at our facility)” are identified by type of facility in the
table below:
Facility type
Community based organization (CBO)
Health department
Hospitals
Counseling and testing site
Independent

Responses
9
6
3
4
1

14.e) Do you have the same test result reporting procedures for all Reactive (preliminary
positive) HIV rapid tests? (Check only one).
Same reporting
procedures for all
reactive tests?
Yes
No, our result reporting
procedures depend on the
purpose for which the HIV
rapid test is ordered
I do not know the reporting
procedures for reactive
HIV rapid tests

Responses
(n=286 sites)
243

29

14

38

15.a) For NON-Reactive (Negative) HIV rapid tests, is this test result given the same day to
the client/patient (the person whose sample was tested for HIV)?
For non-reactive
tests, is the result
given the same
day?
Yes
No
Unknown

Responses
(n=295 sites)
235 (80%)
34 (12%)
26 (9%)

The tables below compare the practices of reporting preliminary positive results (question 14a) with
the reporting of non-reactive results (question 15a).
YES, initially reactive test results are given to
patient/client on same day
Non-reactive test results are
given the same day
Yes
No
I don't know

Responses
(n=203)
201 (99%)
1 (<1%)
1 (<1%)

NO, initially reactive test results are NOT
given to patient/client on same day
Non-reactive test results are
given the same day
Yes
No
I don't know

Responses
(n=61)
25 (41%)
31 (51%)
5 (8%)

I DON'T KNOW if initally reactive test results
are given to patient/client on same day
Non-reactive test results are
given the same day
Yes
No
I don't know

Responses
(n=29)
7 (24%)
2 (7%)
20 (69%)

39

15.b) If “yes” to question 15a: Who gives the result of the HIV rapid test to the client/patient
(the person whose sample was tested for HIV)? (Check all that apply)
Result provider
The client/patient's health
care provider
The person who performed
the test
A counselor (who did not
perform the test)
Other*
Unknown
Total responses

Responses
(n=233 sites)

% Responses

118

40%

113

38%

57
6
4
298

19%
2%
1%

Note: Of the 235 sites that answered “Yes” to question 15a; two sites gave no response to
question 15b.
*Of the 6 facilities that responded “Other”:
• 3 facilities indicated that the results are given by the HIV program specialist/coordinator,
• 2 facilities indicated that the results are given by the employee health nurse, and
• 1 facility indicated that the person can vary.
15.c) If “no” to question 15a, please check all that apply:
Non-reactive test results are not given to the
client/patient on the same day as the test:
Responses
(n=28 sites)*
Non-reactive HIV test results are reported to the
client/patient's physician or health care provider
Non-reactive HIV results are reported to
employee/occupational health OR infection control
Non-reactive HIV test results are NOT reported to
the client/patient
Other non-reactive result reporting procedure
Total responses

22

19
8
2
51

*Note: Of the 34 sites that answered “no” to question 15a, six sites gave no response
to question 15c.

40

15.d) Where do the reporting procedures for non-reactive (negative) HIV rapid tests
occur? (Check all that apply).

Location of reporting
procedure

Responses
%
(n=271 sites) Responses

In our facility, in the
department where testing is
performed

223

76%

At another area of our facility
(NOT the testing site)

43

15%

Externally (NOT at our facility)

20

7%

I don't know
Total responses

7
293

2%

15.e) Do you have the same test result reporting procedures for all non-reactive (negative)
HIV rapid tests? (Check only one).
Same reporting procedures for all
non-reactive tests?
Yes

Responses
(n=286 sites)
251

No, our result reporting procedures
depend on the purpose for which the
HIV rapid test is ordered

27

I do not know the reporting procedures
for non-reactive HIV rapid tests

8

41

16.a) For initially reactive (preliminary positive) HIV rapid tests, what is the typical
referral procedure for the client/patient (the person whose sample was tested for
HIV?) (Check all that apply).
Health c are provider

105

HIV c ounseling center

55

Employee/occ upational
health

53

Client/patient given a list of
HIV resources

N=351 responses
n=198 tes ting s ites

41

Health department

37

Unknown/other is
res ponsible

16

Client arranges own
follow-up care

9

Other

35
0

20

40

60

80

100

120

Number of Responses

There were 77 testing sites that responded they had no referral procedure.

The table below outlines the responses for “Other” in the above question:
Category
Not defined
Case management
Mental health services
Infectious disease/HIV clinic
Medical director for unassigned patient
Tribal health
Our clinic
N/A: our testing does not involve patients

Responses
19
8
2
2
1
1
1
1

42

16.b) For confirmed positive HIV rapid test results:
If a client/patient has a preliminary positive rapid test that is confirmed positive, is there a
formal or informal protocol to refer this client/patient for follow-up care (medical, counseling,
etc.)? (Check all that apply).

Facility type
Hospital (n=117)
Health department (n=36)
Community based organization (CBO) (n=31)
HIV counseling and testing site (n=30)
Alternative sites* (n=11)
Family planning center (n=10)
Other (n=10)
Physician's office (n=8)
Blood bank (n=8)
Independent laboratory (n=5)
Total n=266

Yes

No

98 (84%)
32 (89%)
30 (97%)
30 (100%)
11 (100%)
9 (90%)
9 (90%)
6 (75%)
6 (75%)
4 (80%)
235 (88%)

19 (16%)
4 (11%)
1 (3%)

1 (10%)
1 (10%)
2 (25%)
2 (25%)
1 (20%)
31 (12%)

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit.

If “Yes”, i.e. there is a protocol for referral to follow-up care after a confirmed positive HIV
rapid test, which of the following options does the protocol include? (Check all that apply).
Responses
(n=205 sites)

% Responses

Health care provider

154

31%

Given list of HIV resources

81

16%

Counseling center

75

15%

Health department

71

14%

Employee/occupational resources

63

13%

Arranges own follow-up care

23

5%

Follow-up/referral

10

2%

Unknown/other is responsible

8

2%

9
494

2%

Referral protocol for confirmed positive

Other
Total

Note: Of the 235 sites that answered “Yes” to question 16b, 30 sites gave no response
specifying referral protocol.

43

16.c) For NON-REACTIVE HIV rapid test results:
What is the typical referral procedure for the client/patient tested?
(Check all that apply)
Ref er to health care
provider or physician

60

Refer t o empl/occ.
health/inf ec tion c ont rol*

38

N=181 responses

Refer to HIV counseling
center

27

Varies**

n=142 testing sites

19

Unknown

15

Other

9

Follow-up testing***

7

Client/patient given a list of
s ervices

6
0

10

20

30

40

50

60

70

Number of Responses

Note: There were 132 sites that responded they had no referral procedure.
* Refer to employee/occupational health/infection control
** “Varies” includes: varies by client, depends on clients' needs, depends on whether test is for
high risk vs. low risk client.
*** “Follow-up testing” includes: follow-up testing referral, counseling and post-window testing.

The following table outlines the “Other” responses for the above question:
Category
Prevention counseling
University
N/A testing does not involve patients
Infectious disease, HIV clinic or infection control
Support group
Social services
STD clinic and/or van

Responses
2
2
1
1
1
1
1

44

17.a) Does your facility/testing site provide onsite HIV counseling to clients/patients?
Of the 277/298 sites currently performing HIV rapid testing that answered the question,
there were:
• 242 (87%) “Yes” responses, and
• 35 (13%) “No” responses.

Hospital

101 (81%)

23 (19%)
33 (87%)

Health department

n=277 testing sites

5 (13%)

Community based
organization

32 (100%)

Counseling and testing
site

31 (100%)

Yes (n=242)
No (n=35)

11 (100%)

Alternat ive sites *

10 (100%)

Other

9 (90%)
1 (10%)

Family planning center

7 (88%)
1 (13%)

Physician's of fice

5 (63%)
3 (38%)

Blood bank

3 (60%)
2 (40%)

Independent lab
0

20

40

60

80

100

120

Number of Res ponses

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit.

45

17.b) At your facility/testing site, who provides the client/patient consultation for initially
reactive (preliminary positive) HIV rapid testing results?
(Check all that apply).
3 5%

3 0%

29%

29%

N=399 respons es
n=262 testing sites

Percent of Responses

2 5%

2 0%

1 5%

12%
10%

1 0%

7%

6%

5%

5%
2%

0%
Phys ic ia n

C ounse lor

R N/LPN

N urs e
pra ctitione r

Othe r

Not prov ide d

P A*

Psyc hologis t

Person Providing Consultatio n
*PA = Physician's Assistant

The following table outlines the “Other” responses for the above question:

Category

Number of
responses

Unknown

7

Disease intervention, infectious disease, HIV clinic, or
infection control

5

Other staff: volunteer, medical assistant, mobile advocate,
virologist, microbiologist, or social worker

5

Project, lab or case director, manager, or administrator

4

HIV program specialist/coordinator

2

Trained worker: outreach and/or peer education

2

Employee health nurse or other staff

1

46

18.a) Is there a procedure at your facility to report reactive (preliminary positive) HIV
rapid testing results to an outside entity for purposes of surveillance?
140

132

n=279 testing sites

120

Number of Responses

100

80
69
62
60

40

16

20

0
Yes, but only after
results are confirmed

Yes

No

I don't know

If “Yes”, is reporting for surveillance mandatory (see table below)?
Yes, reporting is mandatory
(n=144)
Facility type

Yes, for preliminary
positive HIV-RT tests
(n=40)

Yes, for confirmed
positive HIV-RT tests
(n=104)

Hospital

18

42

Health department

6

18

Community based organization (CBO)

6

16

HIV counseling and testing site

7

12

Alternative sites*

2

6

Blood bank

1

4

Other

3

Independent laboratory

1

Family planning center

1

Physician's office
*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit.

1

Of the 201 sites that report reactive HIV rapid tests for surveillance purposes,
• 3 sites responded that their surveillance reporting is not mandatory, and
• 54 gave no response to question about whether or not their surveillance is mandatory.
47

18.b) What is the typical HIV rapid testing results reporting procedure for the purposes of
HIV surveillance? (Check one best answer for each column).

30

Report directly to health
department

79

76

Not reported

2

Simultaneously report
results to both health
department & health
care provider

25
68

Re port to physician
first; physician reports
to health departme nt

30
23
Preliminary pos itive/reactive results (n=165)
4

Other

HIV positive/confirmed results (n=179)
7

0

10

20

30

40

50

60

70

80

90

Number of Testing Sites

The following table outlines the “Other” responses to the above question:
Category

Responses

Results reported to doctor only

5

University

3

If the patient/client does not return for confirmatory testing, the
preliminary results are reported to the health department

2

Uniform Reporting System (URS) Data Collection for AIDS Institute

1

48

18.c) To which health department(s) do you report HIV rapid testing results?
(Check all that apply, for each column).
134

State/Provincial

44
87

Local

19
9

None

104

Federal surveillance
system

7
1
3

Ministry of Health/National
health authority

N=413 responses

National Reference
Laboratory

1

Other*

2

N/A client is ref erred
els ewhere

2

n=213 t esting sites
HI V c onfirmed results (N=242, n=132)
Preliminary positive/reac tive results (N=171, n=81)

0

20

40

60

80

100

120

140

160

Numbe r of Respons es

* “Other” values:
• University
• Unknown, done by reference laboratory performing testing

49

19.a) How often does your facility/testing site run control material purchased separately
(positive or negative controls not included in the test kit) when performing HIV
rapid testing? (Check all that apply).

New lot number

199

Periodic interval

139

Test s torage temperature
c hange

135

New s hipment

134
127

By each new operator

New box

121

T es t area temperature
c hange

119

With each run

69
N=1072 responses
n=280 testing sites

29

Never*
0

50

100

150

200

250

Numbe r of Responses

*Most of these responses reflect the use of HIV rapid test kits that include quality control
material as part of the kit.

50

19.a) continued;
The following graph details the time periods for those who specified that they run
quality controls at periodic intervals.
Weekly

43

Monthly

37

Daily

25

Af ter certain # tes ts

18

Other

10

N=139 responses
With every shift change

6

0

5

10

15

20

25

30

35

40

45

50

Number of Responses

The following table outlines the “Other” responses for the “periodic intervals” category
in the above question:
Category

Responses

Other time period; every:
2 weeks, 2 months, quarterly

4

Every day of testing (not same as daily)

3

As needed

1

Other number tests: if > 25 tests/shift,
When we have unusual, unexpected, or invalid
test results

1
1

The table below shows the top three response combinations of quality control use:
Top 3 Combinations of answers for Question 19A
Answer combinations
Responses
New operator, new lot, and new shipment
27
New operator, new lot, new box, new shipment, and weekly
9
New lot, new box, and new shipment
8

51

19. b) What is the source of the control material referred to in question 19a?
(Check all that apply).

Purchased separately from
the same manufacturer as
test kits

189

Purchased separately from
a different manufac turer

23

18

Prepared in-hous e

N=244 responses
n=235 tes ting s ites

14

Other

0

20

40

60

80

100

120

140

160

180

200

Number of Responses

The following table outlines the “Other” responses to the above question:

Category

Responses

Proficiency survey samples

4

State health department
Other QC source:
NRL-Australia, NICD/WHO, ACCURUN Product

4
3

Unknown/not specified

3

52

20.a) In which external quality assurance (EQA) HIV rapid testing proficiency test (PT) or
performance evaluation (PE) does your facility participate?
(Check all that apply).
MPEP

295

25

CAP

117

3

Wisconsin State Lab of
Hygiene

21

American Pro ficiency
Institute (API)

N=501 respons es
n=320 testing sites

11

NY Sta te Dept. of
Health

9

American Assoc. of
Bioanalysts (AAB)

7

U.S., N=466, n=295
Non-U.S., N=35, n=25

Other state pro gram 15
Other

1
4

National pro gram

2
0

50

100

150

200

250

300

350

Number of Responses

The following table outlines the “Other State”, “Other National” and
“Other” responses to the above question:
PT or PE Program
STATE Program
Delaware
MDPH (Mass. Dept. of Public Health) PT Training
Montana Public Health Lab QA Program
Pennsylvania Dept. of Health
South Africa/WHO
NATIONAL Program
Institute of Public Health in Belgium
Not specified
OTHER Program
AFSSAPS (France)
Blood Center Sao Paulo Brazil
CTCB-Toulousian Center for Control of Biology
Internal PT
NRL - Australia

Responses
1
2
1
1
1
1
1
1
1
1
1
1

53

20.b) If you are a U.S. testing site, does your site have a government-issued CLIA
certificate of waiver or another type of CLIA certificate that allows you to test?
U.S. sites with
CLIA certificate Responses
Yes
No
Total

231
12
243

Note: 31 U.S. sites currently performing HIV rapid testing did not answer the question.
If “Yes”, what type of CLIA certificate? (Check only one).
Certificate of accreditation

112

Certificate of waiver

79

Certificate of compliance

n=231 testing sites

32

Registration certificate

5

Certificate for providerperformed microscopy

3

0

20

40

60

80

100

120

Number of Testing Sites

C
er
t.
o

U.S. facility type
Blood bank
Hospital
Health department
Independent laboratory
Family planning center
Alternative sites*
Physician's office
HIV counseling and testing site
Community based organization (CBO)
Other
Totals

fa
cc
re
di
C
ta
er
tio
t.
n
of
w
ai
ve
r
C
er
t.
of
co
m
pl
ia
R
nc
eg
e
is
tr
at
io
n
C
er
C
t.
er
t.
fo
rm
ic
ro
sc
op
y

The following table shows the type of CLIA certificate by type of facility

4
93
2
3
1
6
2
1
112

5
11
3
10
22
27
1
79

9
14
1
5
1

1
3

2

1

2
1

32

5

3

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit.

54

20.c) Who performs proficiency testing or performance evaluation testing for HIV rapid
testing in your testing site? (Check all that apply).
Medic al
technologist/clinical lab
sc ientist

182

Medical technician

96

HIV c ounselor

78

Person with BS/BA in lab
science

43

Other

N=492 responses
n=282 testi ng sites

35

Nurs e/nurse practitioner

31

Pers on with associate
degree

27
0

20

40

60

80

100

120

140

160

180

200

Number of Responses

The following table outlines the “Other” responses for the above question:
Category
Project, lab or case director/manager/administrator
Testing or site HIV coordinator
Phys. Asst./nurse-aide or assistant/Phlebotomist
MD or a person with graduate degree in lab science
Person with BS in community health
Prevention department supervisor
Health educator
State personnel from health department
Medical director
Not specified

Responses
10
7
6
2
1
1
1
1
1
5

55

21.a) Approximately how much does your facility charge to perform an HIV rapid test?
(Round off to nearest U.S. dollar. Put $0.00 in the box if there is no charge.)
140

n=232 testing sites
120

U.S., n=213
Non-U.S., n=19

118

100

80

60

40

40

23
20

23

14
1

4

1

3

4

1

0

No Charge

$1-$4

$5-$10

$11-$20

$21-$50

$51-$100

>$100

21.b) Do you accept insurance reimbursement only, so that there is no actual payment
for the HIV rapid test by the client/patient?

Lab Type
Blood bank
Hospital
Health department
Independent laboratory
Family planning center
Alternative sites*
Physician's office
HIV counseling and testing site
Community based organization (CBO)
Other
Totals

Yes
1
19
1
2
4
2
29

Reimbursement acceptance
No
N/A - no charge I don't know
3
1
2
20
18
59
13
22
1
1
3
5
2
1
1
11
2
1
1
8
21
1
3
27
4
4
59
108
68

*Alternative sites include: HMO, medical examiner, STD clinic, correctional facility,
drug treatment center and mobile unit.

56

22.a) In your opinion, what are the advantages and disadvantages of HIV rapid testing for
client/patients, as compared to traditional, non-rapid HIV testing? (Check all that
apply).
Rapid testing allows more people to
know their HIV status

202

Easy to explain rapid tes t to clients who
cannot read well

68

Rapid s tart of treatment & other s ervic es

38

Ease of test; no blood draw or
decreas ed anxiety for patient

12

patients
moreand
likely
to get
is k patients areHigh
morerisk
likely
to getare
results
follow
up
res
ults
and
follow
up
care
care

10

Advantages
Disadvantages
Other

Clients/patients may not feel prepared for results

39

Rapid Tests inc rease patient anxiety

38

Other

N=433 responses
n=267 testi ng sites

26
0

50

100

150

200

250

Number of Re sponses

The following table outlines the “Other” responses for the above question:
Category

Responses

No opinion; not applicable
Advantages

6

Faster test and results; decreased waiting time

7

More convenient for patient
More effective in outreach settings; rapid information to health
care provider; for "various" and "other" reasons

4

Low cost

1

Lower false positive than EIA
Disadvantages

1

Higher false positives

2

Gives a false sense of security for a negative test

1

4

57

22.b) In your opinion, what are the administrative advantages and disadvantages of HIV
rapid testing, as compared to traditional, non-rapid HIV testing?
(Check all that apply).

Rapid tests were easily
integrated into my
organization

199

My organization
encourages rapid tests

137

Rapid tes t kits are too
expensive

63

It was difficult to design a
rapid tes ting protocol for
my organization

Advantages

17

Disadvantages
Other

It is expensive to s tart up
a rapid testing program

17

Other

N=460 responses
n=263 testing si tes

27

0

50

100

150

200

250

Number of Responses

The following table outlines the “Other” responses for the above question:
Category
N/a, none, no opinion or no experience
Advantages
Faster results and start of analysis and/or treatment
Required screenings are easier (e.g. neonatal)
Disadvantages
Extra cost in time/staff/paperwork especially with low volume #
tests (e.g.must still do QC): i.e. overhead is more expensive
Transition from conventional testing is extra work
Problems if false positive
Not a routine protocol
Lack of sufficient training
Not specified

Responses
7
5
2

8
1
1
1
1
1

58

22.c) In your opinion, what are the administrative advantages and disadvantages of HIV
rapid testing, when used in field settings such as mobile units/vans?
(Check all that apply).
Rapid tests are more appropriate for field use than
non-rapid HIV tests

126

Test kit temperatures are hard to regulate
in field settings

71

Difficult to maintain client/patient confidentiality in
field settings

64

My organization is unable to provide confirmatory
tests to client/patients in the field

53

Challenging to read rapid test results in field settings

22

Advantages
Disadvantages
Other / neither

No opinion or experience; not applicable

41

N=394 responses
n=234 testing sites

17

Other
0

20

40

60

80

100

120

140

Number of Responses

The following table outlines the “Other” responses to the above question:
Category

Responses

Reduced wait time for results; client on hand for
counseling

2

Advantage

Convenience to test; versatile for testing
situation
Disadvantage

2

Concerns about variable testing conditions, QC
needs or documentation problems

5

Non-optimal conditions for giving results to
patient. No direct access to support

3

Confirmation requires a repeat visit

2

Funding or liability concerns

2

Materials needed for both rapid testing and
conventional HIV testing

1

59