The World Health Organization (WHO) issued a field safety notice on 16 Nov 2011 concerning SD Bioline HIV-1/2 v3.0 manufactured by Standard Diagnostics, Inc. According to the notice, some lots of the device showed unacceptably high rate (around 50%) of invalid test results.
Subsequently, WHO issued an information update on 6 Jan 2012 stating that the devices giving invalid test results show a substantial red background in the test window where results are read. This blurs the visibility of the test lines and therefore makes correct interpretation of the test result impossible. This means that no test result can be given, rendering the test invalid.
Standard Diagnostics has conducted a root cause analysis as recommended by the WHO and determined the problem was due to defective sample pad and non-standard shape of nozzle leading to excessive assay diluents migration which would blur the test window where results are read.
According to WHO, there is no evidence that would warrant the retesting of individuals for whom an unambiguous, valid positive or negative test result using this test, has been obtained. A positive HIV test result given to an individual should always be confirmed with a second and/or third test different from the initial screening test. Persons whose test results were invalid (non-readable) would need to be retested as their serostatus remain undetermined.
WHO recommended that national authorities should discontinue use of all affected lots of the product and quarantining also the unaffected lots until further testing can determine their performance.
Further, WHO also recommended any pending procurement of the product should be cancelled, and no new procurement initiated until further notice. WHO will re-inspect the manufacturing site and an information update will be issued afterwards.
According to the local supplier, affected lots have not been distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.