HIV testing: a practical approach  >  Appendix 2: Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2
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Appendix 2: Characteristics of some selected HIV tests 
for detection of HIV-1 and HIV-2

HIV testing: a practical approach    37  Page 38  39 

APPENDIX 2 Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2(1)
 

ELISA tests
Name	Detect-HIV	Wellcozyme HIV-1 + 2	Genelavia Mixt	Innotest HIV-1/HIV-2 Ab	Abbott Recombinant HIV-1/HIV-2 3rd Generation	HIV-1 and/or HIV-2 Recombigen EIA
Manufacturer	Biochem Immunsystemes	We llco me Diagnostics	Sanofi Diagnostics Pasteur	Innogenetics	Abbott	Cambridge Biotech
Sensitivity	100	100	100	100	100	100
Specificity	97.4	96.9	98.5	97.9	100	100
Positive predictive value at prevalence of 0.01% (6%)	0.4 (71.2)		0.7 (98.6)	0.5 (75.2)	100 (100)	100 (100)
Number of tests Per kit (smallest/biggest)	96	96/480	96/480	96	100 (1000)	192
Storage conditions °C	2-8°C	2-8°C	2-8°C	2-8°C	2-8°C	2-8°C
Incubation temperature(2)	18-24°C	37°C and 18-30°C	40°C and 18-25°C	20-25°C and 37°C	20-25°C and 40°C	20-25°C and 37°C
Reader or visual	reader	reader	reader	reader	reader	reader
Equipment needed not provided in the kit(3)	microtitre plate refrigerator spectrophotometric reader	microtitre plate refrigerator spectrophotometric meter washer	aspiration device dilution tubes/rack incubator microtitre plate multichannel refrigerator spectrophotometric reader washer	incubator refrigerator spectrophotometric meter	aspiration device automatic pipette incubator microtitre plate refrigerator spectrophotometric meter washer	aspiration device automatic pipette incubator refrigerator spectrophotometric meter washer
Time to perform single test for 1 serum/90 sera (hours/minutes)	1.45/2.30	1.45/2.15	1.40/2.10	1.50/2.2 5	1.42/2.45 shaken 3.42/4.45 not shaken	2.25/2.55
Ease of performance(4)	less easy	less easy	less easy	less easy	less easy	less easy
Least and largest number of tests run at a time (no. of controls needed per test)	10 to 90 (and 6c)	2 to 90 (and 6c)	3 to 91 (and 5c)	4 to 92 (and 4c)	1 to 15 (20-assay incubation tray) 1 to 50 (60-assay incubation tray)	1 to 8 8
Shelf life at 2 - 8 °C if not stated otherwise	9 months	9 months	12 months	6 months	60 days	12 months
Costs per test (supply by WHO, bulk purchase prices)(5)	US$2.5	US$1.5	US$1.5 per 96 (US$0.70 per 480)	US$1.9	US$1.78 per 100 (US$1.66 per 1000)	US$1.65
Suitability for small blood banks(6)	less suitable	less suitable	less suitable	less suitable	less suitable	less suitable

	Beneficial characteristics
	disadvantage in some settings

(1) These tests have been tested and approved by WHO. Selection of these tests does not exclude the possibility that others might prove better.
(2) According to recommendations of producer.
(3) Main equipment only. Consumables e.g. reagents, pipette tips, etc. are not included.
(4) 30 parameters of performance e.g. dilution procedure, washing, etc.
(5) Costs as provided by the distributor in Belgium during evaluation (as offered by WHO bulk purchase programme). Costs may have changed since.
(6) High sensitivity and specificity, long shelf life a t ambient temperature, reasonable cost, ease and rapidity of performance.

Adapted from Operational characteristics of commercially available assays to detect antibodies to HIV-1 and/or HIV-2 in human sera.
WHO, Geneva, Reports 3-11, 1991-1999.

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HIV testing: a practical approach    38  Page 39  40 

APPENDIX 2 - Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2
 

ELISA tests continued
Name	VIDAS HIV-1 + 2	VIRONOSTIKA HIV Uni-Form II	BIOTEST Anti - HIV- 1/-2 recombinant	INNOTEST HIV-1/HIV-2 Ab. s.p.	UBI HIV 1/2 EIA	ETI-AB- HIV-1/2 K
Manufacturer	Bio Merieux s.a.	Organon Teknika BV	Biotest AG	Innogenetics n.v.	United Biomedical Inc.	Sorin Biomedica
Sensitivity	100	100	100	100	100	100
Specificity	97.8	98.8	99.1	98.8	100	98.8
Positive predictive value at prevalence of 0.01% (6%)	97.85 (98.55)	0.83 (84.18)	1.10 (87.64)	0.83 (84.18	100 (100)	0.83 (84.18)
Number of tests Per kit (smallest/biggest)	60	192/576	96/480	96/480	192/960	192
Storage conditions °C	2-8°C	2-8°C	2-8°C	2-8°C	2-8°C	2-8°C
Incubation temperature	37°C	37°C  ± 2 and  18-25°C	40°C and 20-25°C	37°C and 20-25°C	37°C ± 2°C	37°C and 20-25°C
Reader or visual	visual (fluorescent detection)	reader	reader	reader	reader	reader
Equipment needed not provided in the kit	automated analyser automatic pipette refrigerator	automatic pipette incubator microtitreplate multichannel reagent trough refrigerator spectrophotometric reader washer	automatic pipette incubator microtitreplate multichannel reagent trough refrigerator spectrophotometric reader washer	automatic pipette incubator microtitreplate multichannel refrigerator spectrophotometric reader washer	automatic pipette incubator microtitreplate multichannel reagent trough refrigerator spectrophotometric reader	agitator/rocker automatic pipette incubator refrigerator spectrop hotometric reader washer
Time to perform single test for 1 serum/90 sera (hours/minutes)	0.40/2.15	1.40/2.04	1.30/1.58	1.45/2.08	1.15/1.45	1.40/2.04
Ease of performance	very easy	less easy	less easy	less easy	less easy	less easy
Least and largest number of tests run at a time (no. of controls needed per test)	1 to 30 (and 2c)	7 to 92 (and 4-5c)	10 to 90 (and 6c)	4 to 92 (and 4c)	8 to 88 (and 8c)	2 to 90 (and 6c)
Shelf life at 2 - 8 °C if not stated otherwise	6-9 months	12 months	6 months	12 months	12 months	9 months
Costs per test (supply by WHO, bulk purchase prices)	US$3.6	US$1.7	US$1.2	US$1.5	US$1	US$1.5
Suitability for small blood banks	suitable	less suitable	less suitable	less suitable	less suitable	less suitable

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HIV testing: a practical approach    39  Page 40  41 

APPENDIX 2 Characteristics of some selected HIV tests for detection of HIV-1 and HIV-2
 

ELISA tests continued
Name	HIV EIA	Enzygnost Anti-HIV 1/2 Plus	I C E * HIV-1.0.2	VIRONOSTIKA HIV Uni-Form II plus 0	Genscreen HIV 1/2
Manufacturer	Labsystems OY	Behringwerke AG	Murex Biotech Ltd	Organon Teknika BV	Sanofi Diagnostique Pateur
Sensitivity	100	100	100	100	100
Specificity	99.4	99.7	99.4	100	98.5
Positive predictive value at prevalence of 0.01% (6%)	1.64 (91.41)	3.23 (95.51)	1.64 (91.41)	100 (100)	0.66 (80.97)
Number of tests Per kit (smallest/biggest)	96/960	192/960	96/480	192/576	96/480
Storage conditions °C	2-8°C	2-8°C	2-8°C	2-8°C	2-8°C
Incubation temperature	37°C and 20-25°C	37°C and 20-25°C	37°C	37°C and 18-25°C	40°C and 18-30°C
Reader or visual	reader	reader	reader	reader	reader
Equipment needed not provided in the kit	automatic pipette incubator refrigerator spectrophotometric reader washer	automatic pipette incubator refrigerator spectrophotometric reader washer	automatic pipette incubator refrigerator spectrophotometric reader washer	automatic pipette incubator refrigerator spectrophotometric reader washer	automatic pipette incubator refrigerator spectrophotometric reader washer
Time to perform single test for 1 serum/90 sera (hours/minutes)	1.25/1.50	1.40/2.05	2.10/2.30	1.40/2.05	1.40/2.05
Ease of performance	less  easy	less easy	less easy	less easy	less easy
Least and largest number of tests run at a time (no. of controls needed per test)	8 to 88 (and 8c)	2 to 90 (and 6c)	2  to 90 (and 6c)	3 to 91 (and 4-5c)	3 to 91 (and 5c)
Shelf life at 2 - 8 °C if not stated otherwise	12	12 months	9 months	12 months	12 months
Costs per test (supply by WHO, bulk purchase prices)	US$0.90 per 96 (US$0.60 per 960)	US$0.53 per 192 (US$0.43 per 960)	US$0.45	US$0.45	US$0.60 per 96 (US$0.45 per 480)
Suitability for small blood banks	less suitable	less suitable	less suitable	less suitable	less suitable

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HIV testing: a practical approach    40  Page 41  42 

APPENDIX 2 Characteristics of some selected HIV tests for detection o f HIV-1 and HIV-2
 

Simple/rapid tests
Name	Test Pack  HIV-l/HIV-2 Ab	HIVSPOT 1+2	Serodia - HIV -1/2	CAPILLUS HIV-l/HIV-2	Immunocomb II	Dipstick-HIV 1 + 2
Manufacturer	Abbott	Genelabs Diaqnostics	Fujirebio	Cambridge Diaqnostics	PBS Orgenics	Immuno-Chemical Laboratories
Principle	membrane test		agglutination	agglutination	immunodot	immunodot
Sensitivity	100	100	100	100	100	100
Specificity	95.5	100	100	98.8	99.7	98.2
Positive predictive value at prevalence of 0.01% (6%)	0.4 (71.4)	100 (100)	100 (100)	0.83 (84.18	3.23 (95.51)	0.55 (78.00)
Number of tests Per kit (smallest/biggest)	40	20/100	220	20/100	36	46/96192
Storage conditions °C	2-8°C	2-8°C	2-8°C	2-8°C	2-8°C	2-8°C
Incubation temperature	15-30°C	18-25°C	20-25°C	18-25°C	20-26°C	20-28°C
Reader or visual	visual	visual	visual	visual or digital reader	visual or digital reader	visual
Reader variability (% difference in interpretation of results by different readers)	1.4 %	7.2 %	6.3 %	0 %	4.5 %	1 %
Equipment needed not provided in the kit	microtitreplate refrigerator	refrigerator	automatic pipette microtitreplate refrigerator	refrigerator	microtitreplate reagent trough	refrigerator
Time to perform single test for 1 serum/90 sera (hours/minutes)	0.05/1.35	0.02/0.20	2.05/3.00	0.03/1.30	0.40/1.25	0.30/2.00
Ease of performance	very easy	easy	less easy	very easy	very easy	easy
Least and largest number of tests run at a time (no. of controls needed per test)	1 to 8 (and 2c)	1 to 12 (and 3c)	1 to 24	1 to 8 (and 2c)	1 to 10 (and 2c)	1 to 6 (and 2c)
Shelf life at 2 - 8 °C if not stated otherwise	8	12 months	12 months	9 months	12 months	12 months
Costs per test (supply by WHO, bulk purchase prices)	US$4.8	US$4 (US$2.30 per 100)	US$2.8	US$2.8 for 20 (US$2.2 per 100)	US$1.67	US$0.48
Suitability for small blood banks	very suitable	very suitable	suitable	very suitable	very suitable	very suitable

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HIV testing: a practical approach    41  Page 42  43 

APPENDIX 2 Characteristics o f some selected HIV tests for detection o f HIV-1 and HIV-2
 

Simple/rapid tests continued
Name	DIA  (Dot Immuno Assay) HIV 1 + 2	HIVCHECK System 3 Test 3 Kit	HIV TRI-DOT	BIONOR HIV-1 & 2	HIV 1 & 2 DoubleCheck
Manufacturer	Weiner Lab.	Ortho Diagnostic System	J. Mitra & Co. Ltd	Bionor A/S	Orgenics
Principle	immunodot	membrane	membrane	rapid EIA	chromatographic membrane
Sensitivity	99.6	99.6	99.6	00	100
Specificity	99.4	99.7	99.7	98.8	99.4
Positive predictive value at prevalence of 0.01% (6%)	1.63 (91.34)	3.21 (95.49)	3.21 (95.49)	0.83 (84.18)	1.64 (91.41)
Number of tests Per kit (smallest/biggest)	48	100	10/20/50/100	40/200	40
Storage conditions °C	2-8°C	18-25°C	2-8°C	2-8°C	2-8°C
Incubation temperature	25-30°C	room temperature	room temperature	room temperature	22-26°C
Reader or visual	visual	visual	visual	visual	visual
Reader variability (% difference in interpretation of results by different readers)	0.8 %	3.2 %	3.2 %	1.0 %	0.8 %
Equipment needed not provided in the kit	refrigerator	-	refrigerator	refrigerator	reagent trough
Time to perform single test for 1 serum/90 sera (hours/minutes)	0.30/2.00	0.03/0.45	0.03/3.30	0.30/3.00	0.11/4.00
Ease of performance	easy	easy	very easy	very easy	very easy
Least and largest number of tests run at a time (no. of controls needed per test)	1 to 6 (and 2c)	1 to 8 (and 2-3c)	1 to 3 (and 2c)	1 to 37 (and 3c)	1 to 5 (and 2c)
Shelf life at 2 - 8 °C if not stated otherwise	12 months	6 months (at 18-25°C)	12 months	6 months	12 months
Costs per test (supply by WHO, bulk purchase prices)	less than US$1.00	US$4.35	US$1.2	US$2.5 (not WHO)	US$1.35
Suitability for small blood banks	very suitable	very suitable	very suitable	very suitable	very suitable

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