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HSA announcement on HIV Combo Test Kit Recall in Singapore

Dr Tan & Partners takes the recent recall of HIV test kits by the HSA very seriously. We would like to assure our patients that we take our commitment to providing you with quality healthcare with utmost importance.

With regards to the recent Health Sciences Authority (HSA) of Singapore’s announcement on the manufacturer recall of the 4th generation SD BIOLINE HIV Combo test kits, we would like our patients to be informed of the following:

  • It would be impossible to verify exactly how much detection sensitivity is affected for patients who were tested using SD BIOLINE HIV Combo test from February 2016 – May 2017.
  • Our clinics have phased out SD BIOLINE combo testing kits and have been currently using the ALERE HIV Combo and the ALERE Determine Antibody tests which are NOT listed as one of the nine lots recalled by the HSA.
  • Patients who were tested with the 3rd generation ALERE Determine Antibody or 4th generation ALERE HIV Combo tests are not affected by the recall and do not require repeat testing.
  • For those who wish to retest for a peace of mind, you may be tested with the ALERE Determine Antibody or ALERE HIV Combo tests at any of our clinics.

What is the ALERE Determine Antibody test (3rd Generation)?

  • This test detects HIV antibodies which start to appear in the blood from about Day 20-23 post-infection
  • It does not detect p24 viral antigen
  • This test can pick up infection from as early as 3 weeks, but is recommended to perform at 3 months post-exposure for conclusive results
  • The ALERE Determine Antibody test remains as an approved HIV test kit by the HSA

What is the HIV Combo test by ALERE (4th Generation)?

  • This test detects both viral p24 protein antigen and HIV antibodies in blood
  • The p24 antigen starts to be detectable at around Day 14-20 post-infection and peaks around Day 30 before slowly decreasing
  • HIV antibodies will start to form and be detectable from about Day 20-23 post-infection, and will remain in the blood thereafter
  • The ALERE HIV Combo test remains as an approved HIV test kit by the HSA

While we await further instructions from the HSA, we would advise any patient who has been tested using the SD BIOLINE HIV Combo test within the period in question, and who has not performed a repeat test three months or more post-exposure, to consult our doctors for a consultation or retest.

Should you have concerns about your previous tests and would like to be retested using the ALERE Determine Antibody or the ALERE HIV Combo tests, kindly visit any of our clinics listed below. Alternatively, we can also be contacted for more information at hello@dtapclinic.com.sg


Need more advice?

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  1. Crazy

    Hi Tan and partners,

    1)How is CMIA combo test different from ALERE combo test?which is accurate?Test done in India.
    2)Does usage of medicines like seroflo inhaler, romilast B tablet, Enzoflam tablet alter the cmia test results (my results were non reactive 0.12)?
    3)Does consumption of neem leaf juice during periods alter the cmia results (my results were non reactive 0.12)?
    4)Will cmia test be accurate soon after periods for the exposure hapened two years prior?

  2. Hii, Doctor now which test kit is using in your clinic alere or any other ?
    I had done a cobmbo test after 29 days at oct.17 2017 at your clinic .
    I need to retest again?

  3. Hello Dr, I had exposure on the 4 July 2017 and I went for HIV combo test in your clinic at Robertson clinic on the 23 October 2017 and it is negative. Do I need to go for a second test for confirmation? Thank you

    • No, your test is conclusive. If you have any other concerns however, you are free to come down again for evaluation.

  4. Hi Doctor,

    I am taking Prep daily. I came back from overseas. I got bad cough and minor running nose. Would I need to be tested for HIV?

  5. thats only for those who ve done the test at signapore?

  6. Hi Doc,
    I took Hiv Alere combo test in your clinic on 25th day of my exposure. Result came out negative. Do I need to retest on 28th day or retest after test?
    My exposure was insertive unprotected oral from CSW.

    • We would have advised you on the day that while your test at 25 days is very indicative, we cannot officially say it is conclusive until after 28 days of exposure. We would likely also have advised that oral sex is extremely low risk.

      • Thanks for your reply doc. I’m planning to retest on my 30th day. But too scared. Based on your experience, have you seen negative result on 25th and positive result during 28th day? I know it depends on your body immune system. Many thanks in advance.

        • No, personally I have not seen that happen.

          • Thanks a lot doc.. truly appreciate your time.. will retest on 30th day for my peace of mind..

          • Hi Doc, sorry to trouble you again. Pls refer to below link : http://www.askdrtan.com/forum/question/11121.
            Dr.Tan said Alere accurancy is poor. Any idea why?

          • The Alere test has around 99.8% sensitivity so not exactly what I would call “poor accuracy”. Prior to the HSA recall, the SD Bioline was considered 100% sensitive based on studies. The test is the best we have as per what HSA has approved in Singapore.

  7. Hi, my girlfriend did a test in march 2017 and that was 42 days after her high risk sexual encounter (unprotected sex ONS). Is it still conclusive?

    • Based on our information from HSA, while we would still say the SD Bioline combo test is extremely accurate especially at 42 days, we cannot say it with 100% conclusive certainty – if there are any concerns, please do a re-test.

  8. Victoria

    Hi Doctor, I took the SD BIOLINE 4th gen test more than 28 days but less than 3 months from my last sexual encounter (protected) do I still need a retest? Im not sure if the lowered sensitivity applies for people testing at between 14 – 28 days after their exposure. Thank you. 🙂

    • I would say your risk is extremely low, but based on HSA’s current advice we would recommend one more test for a conclusive result.

  9. Herbert

    Dear Doc,

    When did the phase out take place?