VARHS - Variant, Atypical, and Resistant HIV Surveillance Data Elements

Attachment 3 (e)

Adult and Pediatric HIV/AIDS Confidential Case Reports

for National HIV/AIDS Surveillance OMB No. 0920-0573

Supplemental Surveillance Activity 2:

Variant, Atypical, and Resistant HIV Surveillance (VARHS) – Data Elements

Form Approved

OMB No. 0920-0573

Expiration Date XX/XX/20XX

Adult and Pediatric HIV/AIDS Confidential Case Reports

for National HIV/AIDS Surveillance

Variant, Atypical, and Resistant HIV Surveillance (VARHS) Data Elements

Public reporting burden of this collection of information is estimated to average 5 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 persons 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-74, Atlanta, Georgia 30333; Attn: OMB-PRA (0920-0573)

Name	Type	Length	Valid Value	Label	Required Variable Code*
PrimaryIDType	Text	50	Text	Primary ID Type	1†
PrimaryID	Text	14	Text	Primary ID	1†
AlternateIDType	Text	50	PEMS_ClientID	AlternateID Type	4†
			PEMS_FormID
			PCN
			HARS_CityNo
			Code-base Stateno
			Other Local ID
AlternateID	Text	50	Text	AlternateID	4†
INELIG	Text	1	0 = Eligible (default)	Eligibility of Case	2†
			1 = Confirmatory tests non-reactive or negative
			2 = Diagnosed before specified time period
			3 = ARV drugs
			4 = Other
ANONYM	Text	1	1=yes; 0=no	Anonymous Tester?	5†
SITENUM	Text	50	Text; list of valid site numbers will be provided by each project area	Site Number	1‡
SITEEXT	Text	50	Text; for areas that have extensions, otherwise blank	Site Extention	4
YEAR	Text	50	YY	Year of Blood Draw	1‡
SEQNUM	Text	50	Text	Sequence Number	1‡
SPECIMENID	Text	50	Text	SpecimenTracking ID	1
				14 character field, left zero filled
				positions 1-4 = area number
				positions 5-8 = site number
				positions 9-10 = last 2 digits of year of draw date
				positions 11-14 = consecutive numbers for each
				participant enrolled, zero filled on left
				The last four digits need to be in ascending order
				for a given year, but not necessarily consecutive.
ACCESNUM	Text	15	Text	Laboratory Accession Number	4
DRAWDTTM	Text	50	YYYYMMDDHHMM	Date and Time of Draw Date	1
TUBETYPE	Text	1	1 = Clot tube (Red top tube - for serum)	Type of Tube Used for Blood Collection	2
			2 = SST tube (Red and gray tiger top tube - for serum)
			3 = EDTA tube (Purple top tube - for plasma)
			4 = ACD tube (Yellow top tube - for plasma)
			5 = PPT tube (White top tube - for plasma)
			6 = CPT tube (Blue and black tiger top tube - for cells or plasma)
			7 = Finger stick - no tube
			9 = Other
			0 = No information provided
BLDCOMP	Text	1	1= Serum	Type of Specimen Sent from Collection Site	2
			2= Plasma
			3= Whole anticoagulated blood
			4= Dried Blood Spot
			5= Cells
			6= Dried Serum Spot
			7= Dried Plasma Spot
			8= Clotted blood
BLDLAB	Text	1	0= No information provided	Type of Specimen Sent for Resistance Testing	2
			1= Serum
			2= Plasma
			3= Whole anticoagulated blood
			4= Dried Blood Spot
			5= Cells
			6= Dried Serum Spot
			7= Dried Plasma Spot
			8= Clotted blood
COURDTTM	Text	50	YYYYMMDDHHMM	Date and Time of Courier Pick-up From Collection Site	3
DRECDTTM	Text	50	YYYYMMDDHHMM	Date and Time of Receipt in Diagnostic Lab	3
CENTDTTM	Text	50	YYYYMMDDHHMM	Date and Time of Centrifugation	3
SEPDTTM	Text	50	YYYYMMDDHHMM	Date and Time of Separation	3
VOLUME	Text	3	Text	Volume of Serum/Plasma After Separation	3
COND	Text	1	Enter highest relevent number	Condition of the Serum/Plasma	3
			0= no hemolysis
			1= low hemolysis
			2= moderate hemolysis
			3= high hemolysis
			4= lipemic
			5= contaminated
SpecimenFrozen	Text	50	1=yes; 0=no	Was the Specimen Frozen Before Aliquoting?	3§
FREZ1DTM	Text	50	YYYYMMDDHHMM	Date and Time of First Freeze of Specimen before Aliquoting	3
THAW1DTM	Text	50	YYYYMMDDHHMM	Date and Time of First Thaw of Specimen before Aliquoting	3
FREZ2DTM	Text	50	YYYYMMDDHHMM	Date and Time of Second Freeze of Specimen before Aliquoting	3
THAW2YN	Text	1	1=yes; 0=no	Were There Two or More Thaws of Specimen before Aliquoting?	3§
EIADTTM	Text	50	YYYYMMDDHHMM	Date and Time of First Reactive EIA	5
ALIQDTTM	Text	50	YYYYMMDDHHMM	Date and Time of Aliquoting	3
VOLGENO	Text	3	Text	Volume Aliquoted for Genotyping	2
GFRZ1DTM	Text	50	YYYYMMDDHHMM	Date and Time of First Freeze of Genotyping Aliquot	2
GTHW1DTM	Text	50	YYYYMMDDHHMM	Date and Time of First Thaw of Genotyping Aliquot	3
GFRZ2DTM	Text	50	YYYYMMDDHHMM	Date and Time of Second Freeze of Genotyping Aliquot	3
GTHAW2YN	Text	1	1=yes; 0=no	Were there 2 or More Thaws of Specimen Before Aliquoting? (Specimen for Genotyping)	3§
VOLBACK	Text	3	Text	Volume Aliquoted for Back-up Specimen	4
BFRZ1DTM	Text	50	YYYYMMDDHHMM	Date and Time of First Freeze of Back-up Specimen	4
BTHW1DTM	Text	50	YYYYMMDDHHMM	Date and Time of First Thaw of Back-up Specimen	4
BFRZ2DTM	Text	50	YYYYMMDDHHMM	Date and Time of Second Freeze of Back-up Specimen	4
BTHAW2YN	Text	1	1=yes; 0=no	Were there 2 or More Thaws Before Aliquoting? (Back-up Specimen)	4
CNPOSDAT	Text	50	YYYYMMDDHHMM	Date of Western Blot or Other Confirmatory Positive Test	5
GSHPDATE	Text	50	YYYYMMDD	Date of Shipment to Geno Lab	3
GRESDATE	Text	50	YYYYMMDDHHMM	Date and Time Genotyping Results Received at DOH	4
NOTSENT	Text	1	0= Specimen was sent (default)	If Specimen was not sent for genotyping, what was the reason for this?	2
			1= QNS
			2= Viral Load Not detectable
			3= Low Viral Load
			4= Lost
			5= Other
AMPLIFY	Text	50	0= Yes (default)	Did the Specimen Amplify?	1
			1= No
			8= Not attempted or unavailable for attempt
			9 = Unknown
			11=private/commercial lab
SPOTDTTM	Text	50	YYYYMMDDHHMM	Date and Time of Spotting	6
DRYTIME	Text	4	Text	Length of Drying Time (Hours)	6
DRYLOC	Text	50	1 = Standard Laboratory	Drying Location:	6
			2 = Mobile Laboratory
			3 = Field
			4 = Clinic
			5 = Other
SPECIFYLOC	Text	50	Text	Specify the drying location if DRYLOC = Other	6
DIAGDFS	Text	4	1 = HIV Diagnostic Lab	Where was dried fluid spot made?	6
			0 = Site other than HIV Diagnostic Lab
RNALATER	Text	50	1 = Yes	Was Specimen Collection Card Pretreated with RNALater?	6
			2 = No
			9 = Unknown
LocationType	Long Integer	4	1 = DFS Collection Site	Type of Site Where Specimen Was Handled	6
			2 = Public Health Laboratory
			3 = Other Laboratory
			4 =Storage Facility
			5 = Hospital
			6 = Other
			9 = Unknown
StoreTemp	Long Integer	4	1 = Room Temperature	Storage Temperature at Site	6
			2 = 4ºC
			3 = -20ºC
			4 = -70ºC
StoreDTM	Text	50	YYYYMMDDHHMM	Date and Time of Refrigeration or Freeze and Desiccant Addition at Site	6
StoreDes	Long Integer	4	1=yes; 0=no	Was Desiccant Changed Before or After Transport from This Site to Next Site?	6
TransMeth	Long Integer	4	1 = US Mail	Method of Transport from This Site to Next Site	6
			2 = FedEx/UPS/DHL
			3 = Local Courier
			4 = Lab/Health Department Staff
			5 = Other
TransDTM	Text	50	YYYYMMDDHHMM	Date and Time of Removal from Refrigeration or Freeze at Site	6
TransCool	Long Integer	4	1=yes; 0=no	Was cooler or dry ice used for transport?	6
Nucleic Acid Sequence	Text	3000	Text	Nucleic Acid Sequence	1

* Required Variable Codes: 1=required for sequence reporting from any source (VARHS contract laboratory or private/commercial laboratory); 2=required if specimen was sequenced by the VARHS contract laboratory; 3=required if project area specimens are sequenced by the VARHS contract laboratory and the rate of amplification is less than 85%; 4=optional ; 5=no longer collected; 6=required for dried fluid spot specimens only.

† Variables were not included in the technical guidance because they are variables used to link VARHS data to HARS or are associated with surveillance processes.

‡ Variables were not included in the technical guidance because they are used to create the variable SpecimenID and so are implicitly required.

§ Variables were not included in the technical guidance but are associated with the variable GFRZ2+YN