Singapore HSA approval SARS-CoV-2 Antigen Rapid Test Kits for professional use

Singapore HSA approval SARS-CoV-2 Antigen Rapid Test Kits for professional use

1. Product Description 

 Lumigenex SARS-CoV-2 Antigen Rapid Test Kits has been listed in BfArM white list for professional use as well as self-test use. It has good performance and with high sensitivity to detect the antigen at the early stage of infection. High performance rapid test enables immediate treatment or isolation measures to minimize transmission.

Intended Use: An in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. Antigen Rapid Test Kit is for professional use and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The Antigen Rapid Test Kit may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The Singapore HSA approval SARS-CoV-2 Antigen Rapid Test Kits is not intended to be used as a donor screening test for SARS-CoV-2.

2. Specification

3. Individual package European common list of SARS-CoV-2 Antigen Rapid Test Kits

​•  Got Singapore MOH approval. With ISO 13485 quality system, CE mark.

​•  Has been listed in EU common list, BfArM white list for professional and self test use. Quality is acceptable by the European Union 27 countires

​•  No specific training is needed 

​•  Test results in 15 minutes

​•  Point of care testing

​•  No special/additional instruments required

​​•  Can be used in a wide variety of non-laboratory settings

• Lumigenex has 11 years history, and has won good reputation around the world for good quality products and professional services,Since 2010. Lumigenex is deeply committed to supporting the global response to end the COVID-19 pandemic.

4. What do my results mean?

Negative: Even if you test negative, please stay vigilant. Do continue to observe safe distancing measures and practice good personal hygiene such as regular handwashing and wearing a mask when leaving your home. Continue to monitor your health and test yourself where necessary.
Positive: You may be infected with the SARS-CoV-2 virus. Please take a photograph of your Antigen Rapid Test results with your identification document and do a confirmatory Polymerase Chain Reaction (PCR) test.
Invalid: An invalid test may mean that the test was not performed correctly. You must perform a second Antigen Rapid Test immediately. If your second Antigen Rapid Test is still invalid, please take a photo of the test result(s) and do a confirmatory PCR test.

5. More Pictures