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HIV Test Kit
There are many HIV test kits available. Some are approved for home use while others are for use in Hospitals or by Doctors only.
At our Clinics, we use the Determine HIV 1/2 Rapid Test, the OraQuick Advance HIV 1/2 Rapid Test and the SD Bioline HIV Ag/Ab Combo Test.
The other HIV test kits approved for use by the US FDA are:
Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits | |||||||
Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
Home Access HIV-1 Test System | HIV-1 | Dried Blood Spot Collection Device | Dried Blood Spot | In Vitro Diagnostic: Self-use by people who wish to obtain anonymous HIV testing | Home Access Health Corp., Hoffman Estates, IL |
7/22/1996 | BP950002 |
OraSure HIV-1 Oral Specimen Collection Device | HIV-1 | Oral Specimen Collection Device | Oral Fluid | For Use with HIV diagnostic assays that have been approved for use with this device. | OraSure Technologies Bethlehem, PA |
12/23/1994 | BP910001 |
OraQuick In-Home HIV Test | HIV-1, HIV-2 | Immunoassay | Oral fluid | Over-the-counter (OTC) diagnostic home-use test. A positive result is preliminary and follow-up confirmatory testing is needed. | OraSure Technologies Bethlehem, PA |
07/03/2012 | BP120001 |
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Anti-HIV-2 Assays(detect antibodies to Human Immunodeficiency Virus type 2) | |||||||
Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
Genetic Systems HIV-2 EIA | HIV-2 | EIA | Serum / Plasma | In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HIV-2. |
Bio-Rad Laboratories Redmond, WA US License 1109 |
4/25/1990 | BL103227 |
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Anti-HIV-1/2 Assays (detect antibodies to Human Immunodeficiency Virus types 1 and 2) | |||||||
Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
ABBOTT PRISM HIV O Plus assay | HIV-1, HIV-2 | ChLIA | Plasma / Serum/ Cadaveric Serum | In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HIV-1 groups M and O and/or antibodies to HIV-2. |
Abbott Laboratories Abbott Park, IL US License 0043 |
9/18/2009 | BL125318 |
Genetic Systems HIV-1/HIV-2 Plus O EIA | HIV-1, HIV-2 | EIA | Serum / Plasma / Cadaveric Serum | In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2. |
Bio-Rad Laboratories Redmond, WA US License 1109 |
8/5/2003 | BL125030 |
ADVIA Centaur HIV 1/O/2 RapidTest | HIV-1, HIV-2 | Microparticle Chemi-luminometric Immunoassay | Plasma/Serum | In Vitro Diagnostic: Qualitative determination of antibodies to HIV-1, including Group O, and/or HIV-2. | Siemens Healthcare Diagnostics, Inc. | 5/18/2006 | BP050030 |
VITROS HIV-1/HIV-2 Reagent Pack and Calibrator | HIV-1, HIV-2 | Immunometric | Plasma/Serum | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2. | Ortho-Clinical Diagnostics, Inc Raritan, NJ US License 1236 |
3/27/2008 | BP050051 |
Multispot HIV-1/HIV-2 Rapid Test | HIV-1, HIV-2 | Rapid Immunoassay | Plasma / Serum | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2. | Bio-Rad Laboratories Redmond, WA US License 1109 |
11/12/2004 | BP040046 |
SURE CHECK HIV 1/2 ASSAY | HIV-1, HIV-2 | Rapid Immunoassay | Fingerstick & venous whole blood, serum, plasma | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | Chembio Diagnostic Systems, Inc. Medford, NY |
5/25/2006 | BP050009 |
HIV 1/2 STAT-PAK ASSAY | HIV-1, HIV-2 | Rapid Immunoassay | Fingerstick & venous whole blood, serum, plasma | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | Chembio Diagnostic Systems, Inc. Medford, NY |
5/25/2006 | BP050010 |
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test | HIV-1, HIV-2 | Rapid Immunoassay | Oral Fluid, Plasma, Whole Blood (venipuncture and fingerstick) | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | OraSure Technologies Bethlehem, PA |
11/7/2002 6/22/2004 |
BP010047 |
Chembio DPP® HIV 1/2 Assay | HIV-1, HIV-2 | Rapid Immuno-chromatographic Assay | Oral Fluid, Serum, Plasma, Whole Blood (Venipuncture, Fingerstick) |
In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | Chembio Diagnostic Systems, Inc. Medford, NY |
12/19/2012 | BP120032 |
Uni-Gold™ Recombigen® HIV-1/2 | HIV-1, HIV-2 | Rapid EIA | Serum, Plasma, Whole Blood (Venipuncture, Fingerstick) |
In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | Trinity Biotech Jamestown, NY |
12/23/2003 02/04/2013 |
BP030025 |
Return to TOC | |||||||
Anti-HIV-1/2 and HIV-1 Antigen Combo Assays (detect HIV-1 antigen and antibodies to HIV Types 1 and 2) | |||||||
Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
ARCHITECT HIV Ag/Ab Combo | HIV-1, HIV-2 | CMIA | Plasma / Serum | In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2. | Abbott Laboratories Abbott Park, IL US License 0043 |
6/18/2010 | BP090080 |
GS HIV Ag/Ab Combo EIA | HIV-1, HIV-2 | EIA | Plasma / Serum | In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2. | Bio-Rad Laboratories Redmond, WA US License 1109 |
7/22/2011 | BP100064 |
Alere DetermineTM HIV-1/2 Ag/Ab Combo |
HIV-1, HIV-2 | Immunoassay | Serum, Plasma, Whole Blood (Venipuncture, Fingerstick) |
In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 and/or HIV-2; point-of-care test. | Alere Scarborough, Inc. Scarborough, ME |
8/8/2013 | BP120037 |
Return to TOC |
Information Courtesy of US FDA Website
Home HIV tests are never 100% accurate. If you choose to do use a Home HIV Test Kit, you should still verify the result with a Doctor.
This is especially so if the result is positive.
Need more advice?
Come down to Our Clinics for a discussion with Our Doctors, or call our clinics for more information.
Email: hello@dtapclinic.com.sg
For lady patients who prefer female doctors, we have professional certified female Doctors to attend to your medical needs.
After exposure, how many days later can do hiv combo test conclusive?
The HIV combo test is conclusive 28 days after exposure.
Dr.. pls I did a test using Alera determinant. saw a faint red in the patient column and a tick red in the control column. what does this explain?
see my other reply
I had a 2nd gen test done oral swab at 1 year post exposured ….is the 2nd generation test accurate and conclusive been negative
At 1 year any HIV test will be conclusive.
Hello doctor, may I ask if these kits are available for sale to bring home? Thank you.
We are working on an e-shop and will keep you informed.
May I self-collect instead?
OIC. Sorry. Sale of the HIV test kit OTC is not allowed in Singapore. The e-shop is only for international patients.
HI, how can i purchase it online and delivered in UAE?
We are currently working on an e-shop. Will keep you posted.
Dear Dr. Tan,
Please help me! I took hiv test at Kanlantan 20 days post exposure. It’s negative, I am not sure what brand they use, and if they test for both hiv-1 and hiv-2. Please kindly advise the accuracy. I am now having swollen lymph nodes all over my body. I am really scared to death now. I am getting depressed.
I am planning to take another test 54 days post exposure. Which test should I go for?
If I take hiv PCR to directly detect the virus, will it be conclusive (8 weeks)? I understand that it costs a lot, how much is it on average?
Thank you so much!
I am not sure what test they use either. I think for accuracy of tests done by other doctors, you should be asking them instead of me. It’s like asking another cook what ingredients were used by the first cook. We can have an idea but can never be 100% sure. If you want to take the PCR test you might as well do it now instead of waiting till 8 weeks.
Hi Dr Tan, thank you very much for your reply! I agree with your analogy. The doctor there (very experienced with 20+ years of hiv experience) told me that it’s 95% accurate. I forgot to ask him if he meant 95% would test accurate by them, Or i have 95% of being tested accurate. What do you think about this? It’s a 4th gen test that tests for both antibody and antigen via Rapid Finger prick test. I am super stressed now, could my swollen lymph nodes be due to anxiety? Thank you once again and kudos to your good work!
Hello Dr Tan,
Thanks you so much for your reply, The alera hiv test that i have used is the alera ag/ab test kit. I used this test on the 39 days and 56 days after potential exposure and both result is negative.
I have been explained by the person who conducted this test the kit would pick up antigen and antibody.
Based on your earlier comment and my explanation, is the test that i have took is a antibody test or combo test?
should I take another test after 3 months?
Thanks you Dr Tan.
It is the combo test and I think it is conclusive for you.
Hello Doctor,
You mentioned that you are using SD Bioline test kit. However im using alera hiv test kit 56 days after potential exposure.
My question is that how conclusive both test in 56 days and also what is the standard window period for these both test kit.
Should i wait for 90 days
Thanks you in advance.
It depends. Both SD and Alere make antibody as well as combo tests. The combo test would be conclusive at 56 days. The antibody test has to be repeated at 3 months.
If 4th gen rapid test was taken at 27 days post exposure and shows up as negative, is it considered conclusive or should a follow up be taken at 90 days?
Officially the 4th Gen test is only conclusive at 28 days. So you have to get another one done. Practically speaking, your tests at 27 days is as good as conclusive.