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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

FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May

The Food and Environmental Hygiene Department (FEHD) today (May 21) released the fourth batch of gravidtrap indexes and density indexes for Aedes albopictus in May, covering 12 survey areas, as follows:

District

Survey Area

May 2026

First Phase Gravidtrap Index

First Phase Density Index

Eastern

Shau Kei Wan and Sai Wan Ho

9.1%

1.4

Islands

Tung Chung

2.0%

1.0

Kowloon City

Hung Hom and To Kwa Wan

6.7%

1.5

Tai Po

Tai Po East

2.2%

2.0

Tai Po West

15.5%

1.0

Tuen Mun

Tuen Mun South

9.1%

1.4

District

Survey Area

May 2026

Area Gravidtrap Index

Area Density Index

Central and Western

Kennedy Town and Shek Tong Tsui

16.8%

1.3

Eastern

Chai Wan

15.4%

1.0

North Point and Quarry Bay

18.9%

1.4

Southern

Aberdeen and Ap Lei Chau

20.8%

1.7

Sha Tin

Sha Tin Town Centre and Fo Tan

18.3%

1.4

Tsuen Wan

Tsuen Wan Town

6.9%

2.3

The fourth batch of gravidtrap indexes for Aedes albopictus in May includes First Phase Gravidtrap Indexes covering six survey areas and Area Gravidtrap Indexes covering six survey areas. Among which, six survey areas recorded gravidtrap indexes above 10 per cent, while Aberdeen and Ap Lei Chau in Southern District recorded a gravidtrap index above 20 per cent. Meanwhile, the gravidtrap indexes of six survey areas, namely Kennedy Town and Shek Tong Tsui in Central and Western District; North Point and Quarry Bay in Eastern District; Shau Kei Wan and Sai Wan Ho in Eastern District; Aberdeen and Ap Lei Chau in Southern District; Tai Po East in Tai Po District; and Tuen Mun South in Tuen Mun District, have recorded a decrease as compared to the indexes recorded in the last survey period, reflecting the progress of relevant mosquito control work.

With reference to the data from the past few years, the gravidtrap indexes start to rise from April or May every year. The actual timing and extent of the rise are affected by factors like weather conditions and rainfall. The average temperature and rainfall recorded in April this year were higher than those in the same period last year, creating favourable conditions for mosquito growth and breeding. As a result, the rise in gravidtrap indexes occurred earlier this year. With the increase in rainfall in May, the gravidtrap indexes are expected to rise further.

For survey areas which recorded indexes exceeding 10 per cent, in accordance with the mechanism implemented by the FEHD in response to the chikungunya fever (CF) situation (i.e. strengthening mosquito control work in areas with a gravidtrap index between 10 per cent and 20 per cent, instead of 20 per cent or above under the original mechanism), the FEHD is collaborating with relevant departments and stakeholders to identify locations with high mosquito infestations and carry out intensive and targeted mosquito control measures. The FEHD has initiated two prosecutions against the relevant construction site contractors following the discovery of mosquito breeding at construction sites in Tai Po District and Southern District. Moreover, following the discovery of stagnant water or stagnant water containers in a park, a construction site, a private housing estate, a clinic and a private premises in Tai Po District, Central and Western District, as well as Southern District, the FEHD has issued five statutory notices to the responsible persons-in-charge, requiring the clearance of such items within a specified timeframe. The FEHD, the relevant departments and stakeholders are following up on the mosquito control work, and will also organise exhibitions, distribute leaflets and posters, and notify residential estates that have subscribed to the gravidtrap Rapid Alert System, advising property management agents and residents to stay vigilant and work together in taking mosquito prevention and elimination measures. In addition, the FEHD will strengthen the monitoring of the gravidtrap index in the areas to review the effectiveness of the mosquito control work.

Public participation is crucial to the effective control of mosquito problems. The FEHD appeals to members of the public to continue to work together in strengthening personal mosquito control measures, including:

  • tidy up their premises and check for any accumulation of water inside the premises;
  • remove all unnecessary water collections and eliminate the sources;
  • check household items (those placed in outdoor and open areas in particular), such as refuse containers, vases, air conditioner drip trays, and laundry racks to prevent stagnant water;
  • change water in flower vases and scrub their inner surfaces thoroughly, and remove water in saucers under potted plants at least once a week;
  • properly cover all containers that hold water to prevent mosquitoes from accessing the water;
  • properly dispose of articles that can contain water, such as disposable meal boxes and empty cans; and
  • scrub drains and surface sewers with alkaline detergent at least once a week to remove any mosquito eggs.
  • Starting in August 2025, following the completion of the surveillance of individual survey areas, and once the latest gravidtrap index and the density index are available, the FEHD has been disseminating relevant information through press releases, its website and social media. It aims to allow members of the public to quickly grasp the mosquito infestation situation and strengthen mosquito control efforts, thereby reducing the risk of CF transmission.

    Following recommendations from the World Health Organization and taking into account the local situation in Hong Kong, the FEHD sets up gravidtraps in districts where mosquito-borne diseases have been recorded in the past, as well as in densely populated places such as housing estates, hospitals and schools to monitor the breeding and distribution of Aedes albopictus mosquitoes, which can transmit CF and dengue fever. At present, the FEHD has set up gravidtraps in 62 survey areas of the community, with a surveillance period of two weeks. During the surveillance period, the FEHD will collect the gravidtraps once a week. After the first week of surveillance, the FEHD will immediately examine the glue boards inside the retrieved gravidtraps for the presence of adult Aedine mosquitoes to compile the Gravidtrap Index (First Phase) and Density Index (First Phase). At the end of the second week of surveillance, the FEHD will instantly check the glue boards for the presence of adult Aedine mosquitoes. Data from the two weeks of surveillance will be combined to obtain the Area Gravidtrap Index and the Area Density Index. The gravidtrap and density indexes for Aedes albopictus in different survey areas, as well as information on mosquito prevention and control measures, are available on the department's webpage (www.fehd.gov.hk/english/pestcontrol/dengue_fever/Dengue_Fever_Gravidtrap_Index_Update.html#).

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May  Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May  Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May  Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May  Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May  Source: HKSAR Government Press Releases

    FEHD releases fourth batch of gravidtrap indexes for Aedes albopictus in May Source: HKSAR Government Press Releases

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