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Standard Diagnostic Bioline (SDB) Rapid HIV Test Kit found Faulty

Posted by on Dec 30, 2011 in HIV, STD | 11 comments

Read original story here: http://www.bbc.co.uk/news/world-africa-16355462

and here: http://www.businessdailyafrica.com/Corporate+News/HIV+testing+kits+recalled+over+accuracy+fears/-/539550/1296788/-/qqjahaz/-/

The Bioline rapid HIV test kit manufactured by South Korea has been found to be faulty.

The WHO has recommended all countries to put on hold the use of Bioline test kits.

If your Doctor is still using the Bioline test kit, please alert him to this.

If you have been tested using the Bioline test kit, please see your doctor and speak to him/her about the need for a retest.

Update 2013 – SD Bioline has worked with WHO and implemented the necessary corrections. WHO has lifted it’s warning on SD Bioline test kits and it is now being used in various healthcare settings.

 

About Dr. Tan
Dr. Tan graduated from the National University of Singapore in 2001. His residency was in the two largest public hospitals in Singapore; Tan Tock Seng Hospital and Singapore General Hospital.

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11 Comments

  1. Nz
    September 28, 2014

    Hi Dr Tan

    Thank u for your fast response.Can i do Elisa lab test anonymously in your clinic.Thx

  2. Nz
    September 27, 2014

    Hi Dr Tan

    Thank you for your kind reply.But for the determine rapid test is it available in your clinic because in your homepage is only sd bioline rapid test.Sorry Doc what about your opinion on oraquick fluids test and lastly are you available on the 16 th of october at 6 pm because i’m flying from sabah to singapore.Thx Dr Tan.Hope to receive your reply soon.

  3. Nz
    September 26, 2014

    Hi Dr Tan

    What are chances of false negative.Do rapid test have the same accuracy pf EIA test.Thx

    • drtan
      September 27, 2014

      Depends on what type and brand of rapid test. Some rapid tests like the Determine, has sensitivities and specificities exactly the same as lab based EIA. As a very general statement, lab based EIAs are more sensitive than rapid tests. The most common cause of false negatives is testing within the window period. For other causes of false negative EIA, click here.

  4. Ng
    February 21, 2014

    Hi Dr. Tan,

    I was tested negative sometime back in 2013, but I can’t remember the exact date, using the 20minutes rapid test.

    Is there a need for re-test because I had just read the article of faulty test-kits

    • drtan
      February 24, 2014

      As long as it is after 3 months from your exposure, you do not need to retest.

  5. lui
    May 3, 2013

    so dr tan as for your study what brand of test kit is the best to use?

    • drtan
      May 4, 2013

      There is no ‘best’ test kit. It all depends on the doctor who is doing the test for you. For myself personally, I have had most experience with the Determine HIV 1/2 by Alere and the OraQuick. So I can advise patients thoroughly on their performance characteristics. Please post any follow up questions on http://www.askdrtan.com

  6. JK
    January 1, 2012

    Hi Dr. Tan

    Thanks for sharing this information with us.