The Department of Health (DH) announced today (July 22) that it had received a notification from the supplier of a rapid antigen test (RAT) stating that a product's Instruction for Use (IFU) needed to be updated to avoid users misinterpreting the test results. The product information is as follows:
Name: Ten Respiratory Pathogens Antigen Test Kit
Supplier: SAVEWO Distribution Limited
Manufacturer: Anhui Deepblue Medical Technology Co., Ltd
Model number: RP1011N-1
Lot numbers: 20250301 and 20250501
According to information provided by the supplier in Hong Kong, the product in question is an all-in-one test for 10 types of respiratory pathogens, including influenza, COVID-19 and H5N1 avian influenza. It has been distributed in the local retail market since March this year. Following internal testing, the manufacturer has updated the IFU to state that if the H5N1 detection zone is positive but the FIuA+B/COV detection zone is negative, the H5N1 avian influenza test result is invalid.
The supplier has uploaded the updated IFU to its official website. Members of the public who have purchased the affected batch of products are advised to contact the supplier at 5503 2370 if they have any queries regarding their RAT test results.
The product concerned is a Class C (moderate-high risk) In Vitro Diagnostic Medical Device and is not listed under the DH's Medical Device Administrative Control System (MDACS).
The DH reminded members of the public that all RATs have limitations, including the possibility of false negative or false positive results. Therefore, RAT test results can only be used for reference purposes and cannot replace the professional diagnosis by doctors. Members of the public should consult healthcare professionals if they have doubts about the results of RATs.
Separately, the DH has introduced a voluntary MDACS, under which a listing system for medical devices and traders, as well as a post-market monitoring system, is in place to ensure that medical devices supplied in Hong Kong meet the safety, quality and performance requirements. Information on listed medical devices is uploaded to the website of the DH's Medical Device Division (www.mdd.gov.hk/en/mdacs/search-database/list-md/index.html). The DH advised members of the public to purchase medical devices listed under the MDACS wherever possible to ensure that the products meet the standards on safety, quality and performance.
The DH will continue to follow up on the incident and take appropriate action.
Reposted from HKSAR Government webpage:
https://www.info.gov.hk/gia/general/202507/22/P2025072200575.htm