Faulty HIV test kits recalled in Singapore

People in Singapore who did a rapid HIV test between February 16 and May 17 have been advised to check with their clinics if they need to be rescreened, after a brand of test kit was recalled by the authorities.

Issuing a press statement, Health Sciences Authority (HSA) said, “HSA was notified by the local importer, Unison Collaborative, that nine lots of SD BIOLINE HIV Ag/Ab Combo assay were recalled by the product owner, Standard Diagnostics, Inc. (SD).”

A brand of HIV test kit has been  recalled by Singaporean authorities.
A brand of HIV test kit has been recalled by Singaporean authorities. Photo courtesy: Highway Mail

It added, “The recall was due to the reduced sensitivity of nine lots of SD Bioline HIV Ag/Ab Combo Assay test kits which could result in false negative HIV results for individuals who were tested during the early stages of an HIV infection. According to the manufacturer, when a patient is in the very early window period, the lower sensitivity of the affected lots may reduce detection, with the possibility of a false negative result for this subset of patients.”

Almost 13,700 tests, involving thousands of individuals, could have been conducted with the faulty kits. 547 (of the kits) have potentially been used, with each kit being able to perform 25 tests.

Dr Winston Lee, said, “They have mostly been tested at one month (using the recalled kit) after risky exposure. In general, we have a practice of encouraging our patients to come back for frequent testing (every three to six months).”

He added, “We are also contacting our patients actively to encourage them to return for a retest with the newly provided test kits.”

Issuing a consumer advisory, HSA said, “Healthcare providers routinely advise persons with high risk of HIV exposure who tested negative for HIV infection using any brand of rapid HIV test kits to return for another test more than three months after their last exposure to confirm that they are HIV negative. This is to rule out early infections that might not have been picked up at the first screening.”