Rapid HIV Diagnostic Tests Options

When you need to know quickly if your patient has contracted HIV, these options can provide a faster result. Even though follow-up with conventional testing might be required, quickly diagnosing HIV infection is crucial to getting patients started on antiretroviral therapy as soon as possible.

Company	Test/panel	Technology	Notes	Website
Table. Selected Rapid Diagnostic Tests for HIV
Abbott	ARCHITECT HIV Ag/Ab Combo	2-step chemiluminescence microparticle immunoassay (combination antibody/antigen test)	HIV-1 p24 antigen Sensitivity level: 18.39 pg/mL Sample type: serum and plasma Sample volume: 120 mcL for first test, 100 mcL for subsequent tests Sensitivity: 100% Specificity: 99.77% Time to result: 29 min	fda.gov/vaccines-blood-biologics/ approved-blood-products/abbott-architect-hiv-agab-combo fishersci.com/content/dam/fishersci/en_US/ documents/programs/healthcare/technical-documents/ data-sheets/abbott-architect- hiv-ag-ab-sellsheet.pdf
Abbott	DETERMINE HIV-1/2 AG/AB COMBO	Lateral flow assay (combination antibody/antigen test)	HIV-1 p24 antigen Sensitivity level: serum, 12.5 pg/mL and 2 IU/mL³; whole blood, 25 pg/mL and 3 IU/mL³ Sample type: whole blood, serum, and plasma Sample volume: 50 mcL Sensitivity: 100% Shelf life: 24 mo Specificity: fingerstick whole blood, 99.8%; venous whole blood, 99.7%; serum, 99.6%; plasma, 99.7% Time to result: 20 min	www.globalpointofcare.abbott/us/en/ product-details/determine-1-2-ag-ab-combo.html fda.gov/media/86959/download?attachment
Beckman Coulter	Access HIV Ag/Ab combo	Paramagnetic particle, chemiluminescent immunoassay (combination antibody/antigen test)	HIV-1 p24 antigen Sensitivity level: 0.22 IU/mL³ Sample type: serum and plasma Sample volume: 60 mcL Sensitivity: clinical samples, 100% Specificity: 99.7% Time to result: 30 min	beckmancoulter.com/en/clinical-studies-and-trends/ clinical-studies/high-sensitivity-hiv-1-p24-combo-assay fda.gov/media/170911/download?attachment
bioLytical	INSTI HIV-1/HIV-2 Antibody Test	Immunofiltration Assay	Sample type: whole blood, plasma, and serum Sample volume: 50 mcL Sensitivity: fingerstick whole blood, 99.8%; venipuncture whole blood, 99.9%; plasma, 99.9% Specificity: fingerstick whole blood, 99.5%; venipuncture whole blood, 100%; plasma, 100% Time to result: <60 s	fda.gov/media/79719/download?attachment insti.com/hiv-test/
Cepheid	Xpert HIV-1 Qual XC, Xpert HIV-1 Viral Load XC	Reverse transcription PCR	Limit of detection: whole blood, 162 cp/mL; dried blood spot, 706 cp/mL Sample type: venous whole blood, capillary whole blood, or dried blood spot Sample volume: 100 mcL Time to result: 90 min	cepheid.com/en-CH/tests/blood-virology-womens-health- sexual-health/xpert-hiv-1-qual-xc.html infomine.cepheid.com/sites/default/files/2023-01/ Xpert%20HIV-1%20Viral%20Load%20XC%20ENGLISH %20Package%20Insert%20302-4124%20Rev%20D.pdf cepheid.widen.net/view/pdf/ygaambrv4z/ Cepheid-Xpert-HIV-1-VL-XC-GPM-Reference- Sheet-A4-CE-IVD-3359-English.pdf
Chembio	DPP HIV 1/2 Assay	Lateral flow assay	Sample type: saliva, fingerstick blood, venous whole blood, serum, and plasma Sample volume: 10 mcL Sensitivity: saliva, 98.9%; fingerstick whole blood, 99.8%; venous whole blood, 99.9%; plasma, 99.9%; serum, 99.9% Shelf life: 23 mo Specificity: saliva, 99.9%; fingerstick whole blood, 100%; venous whole blood, 99.9%; plasma, 99.9%; serum, 99.9% Time to result: whole blood and plasma, 15 min; saliva, 45 min	fda.gov/media/84916/download?attachment chembio.com/products/dpp-hiv-12-assay-usa/
	HIV 1/2 STAT-PAK Assay	Lateral flow assay	Sample type: whole blood, serum, or plasma Sample volume: 5 mcL Sensitivity: 99.7% Shelf life: 24 mo Specificity: 99.9% Time to result: 15 min	chembio.com/products/hiv-1-2-stat-pak-assay-usa/ fda.gov/media/73233/download
	DPP HIV-Syphilis	Lateral flow assay	Sample type: whole blood, serum, or plasma Sample volume: 10 mcL Sensitivity: >99% Shelf life: 24 mo Specificity: >99% Time to result: 15 min	chembio.com/products/dpp-hiv-syphilis-usa/ fda.gov/vaccines-blood-biologics/blood-blood- products/dpp-hiv-syphilis-system
Diasorin/ Luminex	Liaison XL Murex HIV Ab/Ag HT assay	Chemiluminescent immunoassay (combination antibody/antigen test)	Sample type: serum or plasma Sample volume: 350 mcL Sensitivity: 100% Specificity: 99.5%	us.diasorin.com/en/immunodiagnostics/ hepatitis-retrovirus/liason-xl-murex-hiv-ab-ag-ht fda.gov/media/144261/download
OraSure Technologies	OraQuick ADVANCE Rapid HIV-1/2 Antibody Test	Lateral flow assay	Sample type: saliva, plasma, whole blood Sensitivity: saliva, 99.3%; plasma, 99.6%; fingerstick whole blood, 99.6% Specificity: oral specimens, 99.8%; plasma, 99.9%; fingerstick whole blood, 100% Time to result: 20-40 min Has an OTC option that uses saliva	fda.gov/media/73607/download?attachment oraquick.com (OTC version)
QuidelOrtho	Vitros HIV combo test	Chemiluminescent immunoassay (combination antibody/antigen test)	HIV-1 p24 antigen Sensitivity: 0.46 IU/mL³ Sample type: serum and plasma Sample volume: 80 mcL Sensitivity: 100% Specificity: high-risk population, 99.68% Time to result: 48 min	quidelortho.com/sg/en/laboratory-professionals/ clinical-chemistry-immunoassay/vitros-systems/ infectious-disease-testing-solutions fda.gov/media/118503/download www.fda.gov/media/109697/download
Roche	Cobas HIV-1/HIV-2 Qualitative	Reverse transcription PCR	Limit of detection: Plasma: HIV-1 group M, 12.8 copies/mL; HIV-1 group O, 15.4 copies/mL; HIV-2, 35.4 copies/mL Serum: HIV-1 group M, 12.8 copies/mL; HIV-1 group O, 13.3 copies/mL; HIV-2, 26.3 copies/mL Sample type: serum and plasma Sample volume: 650 mcL Specificity: 100%	diagnostics.roche.com/us/en/products/lab/ cobas-hiv-1-hiv-2-qualitative- 58-68-88-rmd-58-68-88-hivqual.html fda.gov/media/141100/download
	Cobas HIV-1	Reverse transcription PCR	Limit of detection: 13.2 copies/mL Sample type: plasma and dried plasma spot Sample volume: 650 mcL	diagnostics.roche.com/global/en/products/lab/ cobas-hiv-1-rmd-58-68-88-hiv1.html fda.gov/vaccines-blood-biologics/ approved-blood-products/cobas-hiv-1
	Cobas MPX	Reverse transcription PCR	Limit of detection: Plasma: HIV-1 group M, 25.8 IU/mL; HIV-1 group O, 8.2 copies/mL; HIV-2, 4.0 IU/mL Serum: HIV-1 group M, 23.7 IU/mL; HIV-1 group O, 12.2 cp/mL; HIV-2, 4.4 IU/mL Sample type: plasma and serum Sample volume: 650 mcL Multiplex HIV, HCV, and HBV nucleic acid test	diagnostics.roche.com/global/en/products/lab/ cobas-mpx-multiplex-hiv-hcv-and-hbv- 58-68-88-pid00000024.html fda.gov/vaccines-blood-biologics/cobas-mpx
SD Biosensor	Standard Q HIV 1/2 AB 3-line test	Lateral flow assay	Sample type: serum, plasma, and whole blood Sample volume: TK Sensitivity: capillary whole blood: 100%; venous whole blood: 99.01%; serum: 99.84%; plasma: 99.78% Shelf life: TK Specificity: whole blood: 100%; serum: 99.92%; plasma: 100% Time to result: 10-20 min	www.sdbiosensor.com/product/product_view ?product_no=206
SD Biosensor	Standard Q HIV/Syphilis Combo	Lateral flow assay	Sample type: serum, plasma, and whole blood Sample volume: whole blood, 20 mcL, serum/plasma, 10 mcL Sensitivity: 100% Specificity: 99.9% Time to result: 15-20 min	sdbiosensor.com/product/product_view ?product_no=209
min, minutes; OTC, over-the-counter; PCR, polymerase chain reaction; s, seconds.

×Not an exhaustive list

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