The Food and Health Bureau (FHB) and the Department of Health (DH) have completed the investigation of the false positive virus testing results by a private laboratory, and requested the private laboratory to continue to strictly follow the improvement measures to ensure that such incident will not occur again.
The concerned private laboratory is BGI. In late January and earlier this month, the Public Health Laboratory Services Branch (PHLSB) of the DH, when conducting confirmatory tests for preliminary positive specimens referred by the concerned private laboratory on January 29, February 1 and 2, found that the COVID-19 testing results of some of these specimens to be negative. The Hospital Authority (HA) arranged new specimens to be collected from these cases for further testing, which were also tested negative. The incident involved 16 false positive results, including 8 cases from the Targeted Group Testing Scheme for teaching and non-teaching staff and staff of boarding section of special schools on January 29; and 4 cases from the compulsory testing arrangement for residents and visitors of Heng Lok House of Tin Heng Estate in Tin Shui Wai on February 1. The other 4 cases pertained to specimens collected from a mobile testing station and a community testing centre.
The Government attaches great importance to the incident of false positive testing results by the private laboratory. The private laboratory was requested to conduct thorough investigation, submit investigation report with improvement measures.
The concerned private laboratory has conducted a thorough investigation into the root cause leading to false positive results in accordance with the Government's request, and submitted to the DH on February 11 a report examining the potential areas of lapses, including human error, reagents carryover or contamination and environmental contamination as well as the corrective and improvement measures taken. The concerned private laboratory adopted with effect from February 4 additional confirmatory tests on preliminary positive specimens as one of the corrective and improvement measures. It was noted that no further false positive results have been detected from BGI since February 4, after the corrective measure was implemented.
A spokesman of the Food and Health Bureau said, "The Government will continue to follow up the corrective and improvement measures in the report and closely monitor the accuracy of testing service provided by the concerned private laboratory to ensure that similar incident shall not occur again."
In accordance with the existing mechanism of the DH, specimens tested with a positive COVID-19 result in all private laboratories are considered preliminary positive. The specimens must be referred to the PHLSB in accordance with established procedures for confirmatory tests. After a positive result is confirmed by the PHLSB, the Centre for Health Protection will classify the case as a confirmed one. The DH may collect samples for the relevant cases again for further testing if necessary. From mid-November 2020 to February 14, 2021, a total of 3.76 million COVID-19 tests were conducted in Hong Kong, identifying 5 142 positive cases (0.14 per cent).
Persons affected by the incident were sent to HA's facilities and were subsequently tested negative and discharged. Close contacts of the persons affected have also left the quarantine centre. "We extend apologies to the persons affected by this incident," said the spokesman.
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