Nine lots of HIV test kits under the label of SD BIOLINE HIV Ag/Ab Combo assay have been recalled after issues of effectiveness were found.
In a statement issued today, the Health Sciences Authority (HSA) said the "reduced sensitivity" of tests could result in false negative HIV results for some patients tested during the early stages of an HIV infection.
HSA was notified by the local importer, Unison Collaborative, that the nine lots were recalled by the product owner, Standard Diagnostics, Inc. (SD).
Unison Collaborative issued an urgent notice on May 11 to 26 clinics and one hospital which were supplied with the affected kits. Users were advised to stop using the kits and to retest individuals who had tested negative after using them.
All the 36 healthcare facilities supplied with the kits in Singapore had been told by HSA to stop using them and to use other alternative rapid HIV test kits until further notice.
Clinics and hospital have also been advised to review the HIV test results of all individuals tested using kits in the affected lots and to perform re-tests as necessary.
Two groups with a high risk of HIV exposure, and who have taken a rapid HIV test between February 2016 and May 2017, are advised to check with their clinic on the need for a re-test. They are:
1. Those who were tested negative for HIV infection at the clinics listed below between February 2016 and May 2017
2. Those who did not return as advised for a re-test more than 3 months after the last exposure.
Clinics/Hospital supplied with recalled lots
Action for AIDS*
Balestier Clinic and Health
Doctors Clinic & Surgery*
Dr Jeremy Chan Medical Clinic
Dr Soh's Family Clinic*
Elyon Family Clinic and Surgery
iCare Medical @ Wellness Clinic
Island Family Clinic Keat Hong Pte Ltd
Island Family Clinic (Seng Kang)
Kensington Family Clinic*
M Lam Clinic*
National University Hospital (NUH)
Nuffield Medical Siglap Pte Ltd
O2 Medical Clinic
Pinnacle Family Clinic
Platinum Family Clinic
Prudence Family Clinic
Q & M Medical (Tampines)*
Q Medical Clinic Pte Ltd
Sagemed Pte Ltd
Silver Cross Medical
SMG Dermatology Centre
Tanjong Pagar Medical Clinics*
Vienna Medical Clinic
Zenith Medical Clinic
*Anonymous HIV Test sites