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FDA-Approved HIV tests for laboratory use only(CLIA Moderate or High Complexity Tests)a,b 

[For use with: serum, plasma, oral fluid or dried blood spots]HIV Screening Tests 

Test Name

Time totest

resultTarget analyte

(test generation)

Sensitivity forestablished

HIV-1 infectionand sensitivity for

HIV-2 infection

(%) (95%ConfidenceInterval)

Specificity forestablished

HIV-1 infection

(%) (95%ConfidenceInterval)

 Approvedspecimen types

and volumec  Assay format Man

 Abbott Architect HIV Ag/AbCombo Assay

(fully automated CLIA moderateassay)

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  ADVIA Centaur HIV 1/O/2

Enhanced (EHIV)

(fully automated CLIA moderateassay)

3 hours Antibodies to HIV-1

(1st generation)Plasma/serum/

dried blood spots:100 (99.6-100),oral fluid: 99.1f  

Plasma/serum/dried blood spots:100 (99.9-100),oral fluid: 99.6f  

Plasma/serum, DBSor oral fluid collected

with the OraSureHIV-1 oral fluid

collection device, 15μlplasma, serum, or

oral fluid; dried bloodspot ¼” punch 

Enzyme-linkedimmunosorbent assay

(ELISA) e http:

q/ind

ntent

Bio-Rad GS HIV Combo Ag/Ab EIA(manual or semi-automatedCLIA high complexity assay)

>3 hours

HIV-1 p24 antigen andantibodies to HIV-1/2

(4th generation)

Plasma/serumHIV-1 p24: 100%f  

HIV-1: 100 (99.7-100)HIV-2: 100 (98.1-100)

Plasma/serum99.9 (99.8-99.9)

Plasma/serum75 μl 

Enzyme immunoassaymicro-well format

(EIA) e 

rad.co

dg

http://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://upload.wikimedia.org/wikipedia/commons/c/cf/BioTek_ELx405_Washer022310.jpghttp://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://www.bio-rad.com/webroot/web/pdf/cdg/literature/P-143.pdfhttp://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://www.avioq.com/avioq/index.php?option=com_content&view=article&id=61&Itemid=61http://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assayshttp://usa.healthcare.siemens.com/immunoassay/systems/advia-centaur-xp/assays

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HIV Supplemental Tests 

Bio-Rad GS HIV-1/2 Plus O(manual or semi-automatedCLIA high complexity assay)

>3 hours Antibodies to HIV-1/2

(3rd generation)Plasma/serum

HIV-1: 100 (99.8-100)HIV-2: 100 (99.8-100)

Plasma/serum99.9 (99.8-100)

Plasma/serum75μl 

Enzymeimmunoassay micro-well

format(EIA) e 

http:/rad.co

P/M4T

1/HIV

Ortho Vitros ECi/ECiQ Anti-HIV 1+2 Reagent pack

(fully automatedCLIA high complexity assay)

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Test Name

Time

totest

result

Target analyte,

Test generation

Sensitivity for

establishedHIV-1 infection

(%) (95% Confidence

Interval) 

Specificity for

establishedHIV-1 infection

(%) (95% Confidence

Interval) 

Specimen types

and volumec 

 Assay format Man

Multispot HIV-1/HIV-2 Rapid TestCLIA moderate complexity

20 min

Differentiates antibodiesto HIV-1 and HIV-2, canbe used as a screeningtest or as a supplementaltest in a diagnosticalgorithm

Serum or plasma100 (99.9-100)

Serum or plasma99.9 (99.8-100)

Serum or plasma30 μl 

ImmunoConcentration

rad.co

U/2

1

 Aptima HIV-1 RNA Qualitative Assay(CLIA high complexity assay)

> 3hours

HIV-1 Viral RNA(Not applicable)

Plasma/serumsensitivity at 100

copies/ml:100 (99.6-100)

Plasma/serumHIV-1 RNA: 99.8 g 

Plasma/serum500 μl 

Transcription-mediatedamplification of nucleic

acid

p

ser

Bio-Rad Genetic Systems HIV-1Western Blot (CLIA high complexity

assay)

>3hours

 Antibodies to HIV-1(1st generation)

HIV-1 plasma/serum/driedblood spots

established HIV-1infection: 100 g 

Plasma/serum/driedblood spots

HIV-1 indeterminate ratein low risk populationsthat are EIA negative:

10.7% g 

Plasma/serum ordried blood spots

10μl 

Western blotelectrophoresis

(WB)

rad.c

G/Cat

rovi

http://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.bio-rad.com/evportal/en/US/CDG/Category/M4T5JBB9O/Retrovirus-HIV--Western-Blothttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.gen-probe.com/products-services/aptima-hiv-rna-qualitative-assayhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Testhttp://www.bio-rad.com/prd/en/US/CDG/SKU/25228/Multispot-HIV-1/HIV-2-Rapid-Test

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 Fluorognost HIV-1 IFA

(CLIA high complexity assay)

1.5hours

antibodies to HIV-1(1st generation) 

plasma/serumestablished

HIV-1 infection: 100 g 

plasma/serum99.0 g 

plasma/serum10 μl 

indirectimmunofluorescence

(IFA)

http:fluoronical

1ifa_

Cambridge Biotech HIV-1 Serum

Western Blot (CLIA high complexityassay)

> 3hours

 Antibodies to HIV-1(1st generation)

Plasma/serumestablished

HIV-1 infection: sensitivityis not provided in the

product insertg 

Plasma/serum g Plasma/serum

20 μl 

Western blotelectrophoresis

(WB)

http:om/9

OraSure HIV-1 Western Blot (only usedwith specimens collected with theOraSure HIV-1 oral fluid collectiondevice) CLIA high complexity assay

> 3hours

 Antibodies to HIV-1(1st generation)

Oral fluidconfirmed positive AIDS

subjects: 97.5 g confirmed high risk

persons: 99.5 g

 

Oral fluid99.9 g 

Oral fluid150 μl 

Western blotelectrophoresis

(WB)

http:/cs/pdv_1_

H

a The Clinical Laboratory Improvement Amendments (CLIA) sets criteria based on complexity levels of tests. Briefly, there are t hree levels of complexity: 1) Waived – simple, low-risk tests that can be perfo

training that do not require centrifugation of specimens for testing, 2) Moderate Complexity – simple tests that use plasma or serum specimens (must participate in external proficiency testing program) 3)

tests that require trained lab personnel, involve multiple step protocols, frequent quality control, and participation in external proficiency testing program. For more information about CLIA regulations go to

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html

b For more information about using HIV tests in multi-test algorithms see Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline (M53-A) available fo

http://www.clsi.org/source/orders/Product_Display.cfm?section=Shop&task=3&CATEGORY=MI&PRODUCT_TYPE=SALES&SKU=M53A.

c Volume for initial test. Repeat testing of reactive tests may be required based on manufacturer’s instructions. 

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d Abbott Architect HIV Ag/Ab Combo Assay’s average analytica l sensitivity for p24 Ag: 18.1 pg/ml (range 17.8-19.7).

e As antibody assays evolved with different mechanisms of detection the terminology to describe this group of tests is now commonly referred to as “Immunoassays” or “IAs”.  

f Bio-Rad’s GS HIV Combo Ag/Ab EIA assay’s average analytical sensitivity for p24 Ag: 14.8 pg/ml (range 13.2-15.9)

g The 95% confidence interval was not provided in the product insert.

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