Recall of HIV test kits that could give false negative results

 Recall of HIV test kits that could give false negative results
PHOTO: Standard Diagnostics

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

Republic Clinics

Sagemed Pte Ltd

Shim Clinic

Silver Cross Medical

SMG Dermatology Centre

Tanjong Pagar Medical Clinics*

Vienna Medical Clinic

Zenith Medical Clinic

*Anonymous HIV Test sites

chenj@sph.com.sg

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