HSA announcement on HIV Combo Test Kit Recall in Singapore
Dr Tan & Partners takes the recent recall of HIV test kits by the HSA very seriously. We would like to assure our patients that we take our commitment to providing you with quality healthcare with utmost importance.
With regards to the recent Health Sciences Authority (HSA) of Singapore’s announcement on the manufacturer recall of the 4th generation SD BIOLINE HIV Combo test kits, we would like our patients to be informed of the following:
- It would be impossible to verify exactly how much detection sensitivity is affected for patients who were tested using SD BIOLINE HIV Combo test from February 2016 – May 2017.
- Our clinics have phased out SD BIOLINE combo testing kits and have been currently using the ALERE HIV Combo and the ALERE Determine Antibody tests which are NOT listed as one of the nine lots recalled by the HSA.
- Patients who were tested with the 3rd generation ALERE Determine Antibody or 4th generation ALERE HIV Combo tests are not affected by the recall and do not require repeat testing.
- For those who wish to retest for a peace of mind, you may be tested with the ALERE Determine Antibody or ALERE HIV Combo tests at any of our clinics.
What is the ALERE Determine Antibody test (3rd Generation)?
- This test detects HIV antibodies which start to appear in the blood from about Day 20-23 post-infection
- It does not detect p24 viral antigen
- This test can pick up infection from as early as 3 weeks, but is recommended to perform at 3 months post-exposure for conclusive results
- The ALERE Determine Antibody test remains as an approved HIV test kit by the HSA
What is the HIV Combo test by ALERE (4th Generation)?
- This test detects both viral p24 protein antigen and HIV antibodies in blood
- The p24 antigen starts to be detectable at around Day 14-20 post-infection and peaks around Day 30 before slowly decreasing
- HIV antibodies will start to form and be detectable from about Day 20-23 post-infection, and will remain in the blood thereafter
- The ALERE HIV Combo test remains as an approved HIV test kit by the HSA
While we await further instructions from the HSA, we would advise any patient who has been tested using the SD BIOLINE HIV Combo test within the period in question, and who has not performed a repeat test three months or more post-exposure, to consult our doctors for a consultation or retest.
Should you have concerns about your previous tests and would like to be retested using the ALERE Determine Antibody or the ALERE HIV Combo tests, kindly visit any of our clinics listed below. Alternatively, we can also be contacted for more information at firstname.lastname@example.org