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HSA recalls 9 lots of HIV test kits that may give false negative results
image: data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==
File photo of blood being drawn during an HIV test. (Photo: AFP)
05 Jun 2017 05:34PM (Updated: 05 Jun 2017 06:10PM)
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SINGAPORE: Nine lots of a brand of HIV screening test kits have been recalled, after it was found that the kits could result in false negative results for some people in the early stages of an HIV infection, announced the Health Sciences Authority (HSA) on Monday (Jun 5).
The affected lots of SD Bioline HIV Ag/Ab Combo were supplied to 26 clinics and as well as the National University Hospital (NUH), and they were issued an urgent notice by the kits' local importer Unison Collaborator on May 11.
NUH and the clinics were advised to stop using the kits and to retest people who had tested negative using the affected lots.
"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," said HSA in a news release.
SD Bioline HIV Ag/Ab Combo is a rapid HIV Antigen and Antibody combo test, which allows users to screen for an HIV infection earlier. There is usually a window period of up to three months during the early stages of infection when blood tests may be unable to detect the virus, but rapid test kits are able to shorten that window period.
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As a precautionary measure, HSA said all 36 healthcare facilities in Singapore supplied with this brand of test kit - not only the affected lots - have been told to stop using them and to turn to other brands of rapid HIV test kits until further notice.
It added that people with high risk of HIV exposure who have taken a rapid HIV test between February 2016 and May 2017 should to check with their clinic on the need for a re-test.
image: http://www.channelnewsasia.com/imag...c9dba3ae3/CV/hiv-test-kits-recall-clinics.png
List of healthcare facilities that were supplied with the affected HIV test kits. (Photo: HSA)
HSA also stated that all rapid HIV tests are not meant to confirm an infection and are to be used only as an initial screening test.
Positive rapid test results must be confirmed by sending a blood specimen to a clinical laboratory for Enzyme Immunoassay (EIA) testing and further confirmatory testing by Western Blot if necessary.
Source: CNA/am
Read more at http://www.channelnewsasia.com/news...est-kits-that-may-give-false-negative-8913748
http://www.channelnewsasia.com/news...est-kits-that-may-give-false-negative-8913748
HSA recalls 9 lots of HIV test kits that may give false negative results
image: data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==
File photo of blood being drawn during an HIV test. (Photo: AFP)
05 Jun 2017 05:34PM (Updated: 05 Jun 2017 06:10PM)
Share this content
SINGAPORE: Nine lots of a brand of HIV screening test kits have been recalled, after it was found that the kits could result in false negative results for some people in the early stages of an HIV infection, announced the Health Sciences Authority (HSA) on Monday (Jun 5).
The affected lots of SD Bioline HIV Ag/Ab Combo were supplied to 26 clinics and as well as the National University Hospital (NUH), and they were issued an urgent notice by the kits' local importer Unison Collaborator on May 11.
NUH and the clinics were advised to stop using the kits and to retest people who had tested negative using the affected lots.
"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," said HSA in a news release.
SD Bioline HIV Ag/Ab Combo is a rapid HIV Antigen and Antibody combo test, which allows users to screen for an HIV infection earlier. There is usually a window period of up to three months during the early stages of infection when blood tests may be unable to detect the virus, but rapid test kits are able to shorten that window period.
Advertisement
As a precautionary measure, HSA said all 36 healthcare facilities in Singapore supplied with this brand of test kit - not only the affected lots - have been told to stop using them and to turn to other brands of rapid HIV test kits until further notice.
It added that people with high risk of HIV exposure who have taken a rapid HIV test between February 2016 and May 2017 should to check with their clinic on the need for a re-test.
image: http://www.channelnewsasia.com/imag...c9dba3ae3/CV/hiv-test-kits-recall-clinics.png
List of healthcare facilities that were supplied with the affected HIV test kits. (Photo: HSA)
HSA also stated that all rapid HIV tests are not meant to confirm an infection and are to be used only as an initial screening test.
Positive rapid test results must be confirmed by sending a blood specimen to a clinical laboratory for Enzyme Immunoassay (EIA) testing and further confirmatory testing by Western Blot if necessary.
Source: CNA/am
Read more at http://www.channelnewsasia.com/news...est-kits-that-may-give-false-negative-8913748
