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Health Department Updates Instructions for Respiratory Pathogen Test Kit to Prevent Misinterpretation of Results

HK

Health Department Updates Instructions for Respiratory Pathogen Test Kit to Prevent Misinterpretation of Results
HK

HK

Health Department Updates Instructions for Respiratory Pathogen Test Kit to Prevent Misinterpretation of Results

2025-07-22 16:30 Last Updated At:16:38

Instruction for Use for rapid antigen test kit needs to be updated

​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 supplierat 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 DHwill continue to follow up on the incident and take appropriate action.

Source: AI-found images

Source: AI-found images

Government announces updates on follow-up work on Tai Po fire

The three task forces set up by the Government for the fire at Wang Fuk Court in Tai Po - the Task Force on Investigation and Regulation, the Task Force on Emergency Support and Fund-Raising, and the Task Force on Emergency Accommodation Arrangements - are making full efforts to follow up on the support, relief, and investigation work related to the incident. Details are as follows:

Financial and welfare support

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For the Support Fund for Wang Fuk Court in Tai Po, established by the Government, donations received are about $3.4 billion as of noon today (December 13). With the start-up capital of $300 million from the Government, the fund's total has now reached around $3.7 billion. The fund will be used to assist residents in rebuilding their homes and providing long-term and sustained support.

Accommodation support

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As of this morning, a total of 1 392 residents have been accommodated, through the co-ordination of the Home and Youth Affairs Bureau, in youth hostels, camps, or hotel rooms. Another 3 163 residents are currently living in transitional housing units provided by the Housing Bureau or units from the Hong Kong Housing Society (HKHS).

In consideration of the extremely urgent situation of the residents affected by the fire incident, a special arrangement of a full rent exemption has been made earlier by the Housing Bureau to provide accommodation support to those affected residents moving into transitional housing or HKHS projects. In other words, if needed, the affected residents can stay for a longer period of time. The Government will continue to support the affected residents in terms of accommodation, and the residents in need do not have to worry about the relevant rental expenses or the duration of stay.

In addition, staff from the operating organisations of transitional housing and HKHS, as well as volunteers have been working around the clock to furnish the units with essential supplies. Taking Eminence Tower in Hung Shui Kiu as an example, each unit is equipped, upon move-in, with furniture and appliances such as bed frames, mattresses, pillows, cooking stoves and water heaters. Daily necessities including toilet paper, slippers and basic cleaning supplies, etc. are also provided. Such efforts are intended to help the affected residents settle in as quickly as possible.

At the same time, a number of organisations have proactively stationed their staff in some projects to provide residents in need with various forms of support, including free medical and legal consultation services. The Government has also set up service stations in 18 projects where more residents have moved in, providing consultation and support services for residents in need, standing together with them.

Relief supplies and donations

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The supplies donation online platform, established by the Government and the information technology sector, continues to operate, facilitating the registration of supplies donations from organisations and the public. The Government has so far received over 1 800 registrations, of which approximately 30 per cent were submitted by organisations, whereas the others were contributed by the public. The various registered donation items include food and beverages, clothing, daily necessities, bedding, and electrical appliances. The Government is actively assessing residents' actual needs through the relevant policy bureau, government departments, and service organisations for the matching of donated supplies in order to distribute appropriate items in phases to places in need. So far, about 19 600 donation items covering various categories have been distributed to different places. The matching and distribution of supplies will continue.

Regulation and inspection work

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The Housing Department today continued to remove the burnt scaffolding on the external walls of Wang Cheong House, Wang Tai House and Wang Sun House. As the environment at scene is narrow and the scaffolding and the protective nets of individual buildings may be subject to more serious damage, for the sake of safety, the Housing Department will conduct assessments with the Police on the timetable of removing the scaffolding of the remaining four affected buildings. In addition, the Independent Checking Unit of the Housing Bureau has also completed the extraction of concrete core samples from the seven affected buildings at Wang Fuk Court today.

The Development Bureau (DEVB) announced on December 11 a new mechanism for sampling and testing scaffold nets for external walls in Hong Kong. The Buildings Department is preparing for the issuance of a new practice note to registered contractors and will meet with the industry next week. The DEVB is moving ahead in full steam the supporting arrangements to ensure that there are sufficient designated laboratories and a suitable site for off-site sampling work.

Source: AI-found images

Source: AI-found images

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