Form 2 HIV Rapid Testing Form EZ WORKSHEET

S eptember 2009

Form Approved

OMB No. 0920-0595

Exp. Date. 03/31/2010

HIV Rapid Testing Form EZ

WORKSHEET

Report your results Online (password required) at:

http://wwwn.cdc.gov/mpep/results/login.aspx

MPEP number: ____________ (you will need this to enter your results online)

DEADLINE for submission October 26, 2009

Please Note: Test procedures on these samples should be performed in the

same manner as the test procedures used for patient specimens.

WARNING: The HIV-1 antibody-positive samples in this panel have been heated at 56°C for 60 minutes to inactivate bloodborne viruses. Because no inactivation method can offer complete assurance that infectious agents are absent, these samples should be handled as if potentially infectious. Follow the U.S. Department of Labor Occupational Health and Safety Administration (OSHA) standards for bloodborne pathogens (29CFR Part 1910), http://www.osha.gov/SLTC/bloodbornepathogens/index.html

Person completing this form: Name_________________________________________

Title (circle ALL that apply)

MT CLS MLT CLT RN/LPN PhD MD Volunteer Counselor

Other (please specify)__________________

Accreditation/license of above person, if applicable (circle ALL that apply)

ASCP NCA HEW OTHER (please specify)_________________________________

NOTE: If more than one HIV rapid test kit is used, print a copy of this form for each test kit.

If you have questions regarding online submission, please contact the MPEP at:

1-877-360-8502

or contact the HIV Rapid Testing Project Coordinator Leigh Vaughan at:

404-498-2246 or email [email protected]

Use this worksheet as an aid to record results for the rapid HIV test kit used in testing the Performance Sample Panel.

Public reporting of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-24, Atlanta, GA 30333; ATTN: PRA (0920-0595)

1. Rapid HIV test kit used in testing the Performance Sample Panel

Check ONE box (see below) corresponding to Manufacturer and HIV Rapid Test Kit used

PLEASE NOTE: If more than one HIV Rapid Test Kit is used, a separate online form for each test kit is required.

Abbott:	□		Determine HIV-1/2
Bio-Rad:	□ □		Multispot HIV-1/HIV-2 Genie II HIV-1/HIV-2
Chembio:	□		Sure Check HIV (previously Hema-Strip HIV-1/2)
Chembio:	□ □		NON-U.S. labs only! HIV 1/2 Stat-Pak(Cassette) HIV 1/2 Stat-Pak(DIPSTICK)
Efoora :	□		HIV Rapid Test
Fujirebio:	□		Serodia-HIV-1/2
	□ □		Serodia-HIV SDF HIV 1/2 PA
MedMira:	□ □		MiraCare HIV Test Reveal G3 Rapid HIV-1 Antibody Test

Inverness Medical	□ □		Clearview HIV 1/2 Stat-Pak Clearview Complete HIV 1/2
Genelabs Diagnostics:	□		HIV-Spot
J. Mitra & Co. Ltd:	□		HIV- TRIDOT
OraSure:	□		OraQuick ADVANCE Rapid HIV-1/2 Antibody test
Trinity Biotech:	□		Capillus HIV-1/HIV-2
	□		SeroCard HIV
	□		Uni-Gold HIV
	□		Uni-Gold Recombigen HIV
Other: (please specify both	□		_________________________ _________________________
manufacturer & kit)

Please specify: Test Kit Lot#______________ Test Kit Version (if applicable):__________

For the rapid HIV test kit listed above, please indicate:

a) the specimen type(s) normally tested in your facility (check all that apply)

Serum: Plasma: Whole Blood: □Oral fluid (from swabbing gums)

□ Fresh □ Fresh □ Finger Stick

□ Frozen □ Frozen □ Venous □Other (please specify)_____________

b) for what purpose do you use the above HIV rapid test kit

□ HIV initial testing □ non-clinical HIV testing (e.g. research, training, etc.)

( e.g. for patients/clients, □ to determine HIV-1 versus HIV-2 reactivity

needlestick, source patient) □ confirmation of a prior reactive HIV test

3. PERFORMANCE PANEL RESULTS Date of testing:___________________

SAMPLE CODE FINAL RESULT/INTERPRETATION

(from sample vial)

Letter # REACTIVE NONREACTIVE INDETERMINATE INVALID Comments

□□ □ □ □ □ _______

□□ □ □ □ □ _______

□□ □ □ □ □ _______

□□ □ □ □ □ _______

□□ □ □ □ □ _______

□□ □ □ □ □ _______

4. For the kit specified in question #1, does your facility normally run Quality Control (QC)

samples (positive and/or negative controls) when performing HIV rapid testing?

□ No. Thank you for your participation. (go to question #5)

□ Yes. Please complete the following section:

(a) Please indicate the Source of your QC material(s) for the kit specified in question #1:

Same Manufacturer as Test Kit:

QC material packaged in test kit (included as part of test kit order)

□ HIV-1 Positive Control Lot#__________ □ HIV-2 Positive Control Lot#_________

□ Negative Control Lot#__________

Same Manufacturer, but QC material ORDERED SEPARATELY (not included with test kit )

□ HIV-1 Positive Control Lot#__________ □ HIV-2 Positive Control Lot#_________

□ Negative Control Lot#__________

Other Commercial Source (please specify):

Manufacturer:____________________

□ HIV-1 Positive Control Lot#__________ □ HIV-2 Positive Control Lot#_________

□ Negative Control Lot#__________

In-House (prepared by own facility):

□ HIV-1 Positive Control Prep Date________ □ HIV-2 Positive Control Prep Date_______

□ Negative Control Prep Date__________

(b) Description of your QC material (for the kit specified in question #1):

□□ Fill in boxes with numbers (see below) corresponding to type of material used

01. Serum/Plasma

02. Whole Blood

03. Other (e.g. urine, culture media, etc.) Please specify_______________

(c) Frequency of Use of QC material for the kit specified in question #1 (check ALL that apply)

□ With each Run/Set/Batch of patient tests

□ By each new operator prior to testing client/patient specimens

□ When opening new lot number of test kits

□ When opening new box of test kits

□ Whenever new shipment of test kits is received

At periodic intervals:

□ Every shift □ Daily □ Weekly □ Monthly

□ After every ____ (number) tests □ Other ________________

Continued on back

5. For the rapid HIV test kit you specified in question #1, what confirmatory test(s) does

your facility require to confirm a preliminary positive (REACTIVE) HIV Rapid Test result?

(a) □ No confirmatory testing required for the kit specified in question #1. Please submit

your results.

(b) Yes, confirmatory testing is required (check all that apply below):

Confirmatory test(s) performed Confirmatory test(s) performed

AT OUR FACILITY ( test done in-house) at another facility (test sent out)

□ 2^ND rapid test, same test kit □ 2^ND rapid test, same test kit

□ 2^ND rapid test, different test kit □ 2^ND rapid test, different test kit

(specify manufacturer & kit____________ (specify manufacturer & kit____________

□ Enzyme Immunoassay (EIA) □ Enzyme Immunoassay (EIA)

□ Western blot (WB) □ Western blot (WB)

□ Immunofluorescence assay (IFA) □ Immunofluorescence assay (IFA)

□ Other test (please specify): ____________ □ Other test (please specify): ___________

PLEASE DO NOT MAIL THIS FORM!!

The MPEP is currently ONLY accepting results online.

Please submit your results at:

http://wwwn.cdc.gov/mpep/results/login.aspx

If you have questions please contact:

the MPEP at 1-877-360-8502

OR

Leigh Vaughan, HIV-RT MPEP Project Coordinator

email: [email protected]

phone:404-498-2246