HSA Recall of SD Bioline HIV Ag/Ab Combo Assay
AfA was officially notified on the 27th of April 2017 of a voluntary recall of nine lots of faulty test kits by the supplier. HSA subsequently notified us of the recall on the 15th of May 2017. The reason for the recall as explained by the manufacturer was due to the reduced sensitivity of the SD BIOLINE HIV Ag/Ab test kits which could result in a false negative HIV result for individuals who were tested during the early stages of HIV infection.
AfA was supplied with the ineffective lots from February 2016 till March 2017 which is the affected period for 4th Gen tests done at our ATS and MTS. All tests done prior to February 2016 and after March 2017 are not affected by the recall. The test kits have since been replaced with a different brand which is also HSA approved.
What is the SD Bioline HIV Ag/Ab Combo Assay?
The SD Bioline HIV Ag/Ab Combo Assay, sometimes called the 4th Generation test kit, is a rapid HIV Antigen and Antibody Combo test that shortens the window period and enables healthcare facilities to screen for HIV infection earlier. On the 4th generation test kit, an initial test can be done as early as 14 days from exposure and a very strong result can be obtained on the 28th day of exposure.
When did AfA use this test?
SD Bioline HIV Ag/Ab was used for all 4th Gen tests done at the ATS and MTS from Feb 2016 to March 2017.
If I was tested using the SD Bioline HIV Ag/Ab Combo Assay and received a negative result should I retest?
Based on a standard testing protocol that we use at our anonymous testing and mobile testing site, all our clients with high risk exposure are advised to do a confirmation test at 3 months from the time of exposure regardless of the type of test kit used. If the right protocol was followed by the client, the recall should not affect them. Therefore, the recall only affects clients who did an early test (14 days from exposure) but did not follow up with a confirmatory test.
Does the recall affect a 3rd Generation test done during that period?
No, the recall does not affect a 3rd Generation test done during that period. The standard time to do a HIV test is normally one month from exposure for an early test and three months from exposure for a conclusive one. This is normally done on a standard 3rd Generation test kit which is designed for Antibody testing.
What does AfA recommend based on the recall?
We would advise clients who feel that they may have been affected by the recall and who have not done their confirmatory test to come to the clinic where they can be tested again and follow the standard protocol that AfA uses.
All rapid HIV test are intended to be used only as an initial screening test and are not meant to confirm HIV infection.
What action is AfA taking?
AfA offers anonymous HIV tests and does not collect any information about the client and so there is no means of verifying who took the faulty test.
As a good-will gesture AfA will be offering free tests to 50 clients each day over the next 2 weeks from June 19th to June 30th, 2017 at the ATS.
We would advise anyone who feels that they may have been affected by the recall and did not follow the recommended procedure to come to the clinic and get themselves tested again.
For further clarification, please contact our hotline at 6254 0212 or email us at email@example.com