Antigen Rapid Test
Fast. Easy. Simple.
Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens.
- Nasal and Nasopharyngeal swab specimens
- Results in 15 minutes
- Excellent performance compared to molecular methods
- Room temperature storage
The Flowflex SARS-CoV-2 Antigen Rapid Test is authorised for use in Singapore by the Health Science Authority (HSA) under the Pandemic Special Access Route (PSAR) and Pre-Market Approval (PMA). The test does not require skilled professional or equipment to interpret the test results. Suitable for home and office use.
Antigen Rapid Test
Available in Singapore.
How Does the Flowflex™ SARS-CoV-2 Antigen Rapid Test Work?
The test uses a swab specimen to determine a positive or negative COVID-19 result. The swab is swirled in a tube of solution before being dropped into a test cassette. After ten minutes, you can see your results.
About Flowflex™ SARS-CoV-2 Antigen Rapid Test
The FlowFlex has a sensitivity of 97.4% and specificity of 99.7% according to the Product Insert under the PMA granted by HSA. FindDx is a leading independent organization. Evaluation reports published by FindDx are available publicly and forms part of MOH’s evaluation criteria.
On September 2021, the Flowflex became the second COVID-19 Antigen Rapid Test that been issued Pre Market Approval (PMA) after the SD Biosensor Standard Q. Since November 2021, the Flowflex has also approved under the PSAR.
5The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.
Under the PMA, the test is authorized for supply to the healthcare institutions, private hospitals, medical clinics or clinical laboratories licensed under the PHMC Act (Cap. 248). This test may also be supplied to ship vessels and be exported out of Singapore subject to the duties and obligations as stipulated in the Health Products Act and the Health Products (Medical Devices) Regulation 2010.
Under the PSAR, the test is authorized for use by layman for self testing in Singapore. Suitable for use at home, office, workplace, etc.
Omicron Variant update (29th Nov 2021)
Computer simulations known as silico have been conducted and we do not expect any negative impact of the Omicron on the performance of the FlowFlex. MOH has received our in silico analysis report. Download the report here.
There is no obvious difference observed when testing with different nucleocapsid protein recombination antigens (Alpha, Beta, Gamma, Delta, Epsilon, Zeta, Eta, Theta, lota, Kappa, Lambda, Mu and Delta plus) basing on these different variants of SARS-CoV-2. The Omicron variant, by theoretical analysis of the mutations in the nucleocapsid protein, should not interfere the detection by the Flowflex SARS-CoV-2 Antigen Rapid Test. So we do not anticipate that these variants, including Omicron, will have any effect on test performance.
Frequently Asked Questions
Q: What is the difference between Self Testing and Professional Use?
A: Self Testing ART have been evaluated by MOH and HSA for its suitability for use by a layperson. The product inserts are tailored for the layperson, usability studies have been conducted to ensure that it is safe and easy to operate. The professional version can only be healthcare institutions, private hospitals, medical clinics or clinical laboratories. The Self Test version can be supplied to all users.
Q: What is the shelf life and expiration date
A: 14 months from manufacture date. Applications with HSA are underway to extend it. We currently guarantee that all our ARTs have at least 12 months left on the expiration date.
Q: I am a retailer with a physical shopfront, may I resell the FlowFlex ART?
A: Yes, please contact us.
Q: I am an enduser and I would like to purchase at least 1,000 tests. May I get bulk pricing?
A: Yes, please contact us with the desired quantity.
Q: Is the FlowFlex more accurate that the other brands approved under the PSAR for self testing?
A: We think so. Have a look the FindDx independent evaluation reports here. SD Biosensor Standard Q ART and Abbott Panbio ART have been listed on this list.
Q: Which ARTs have been granted PSAR for sale to consumers?
A: Here is the list on HSA website.
Q: May I have more information on the manufacturer?
A: The Flowflex is jointly developed by Acon Labs Inc is in California, USA and Acon Biotech in China. The FlowFlow antigen rapid tests are manufactured in Hangzhou, China. https://www.aconlabs.com/about/
Q: How many tests are there in a box?
A: We have 1 test/box, 5 tests/box and 25 tests/box.
Q: We are a company and have not got a credit card. May we purchase other payment methods?
A: Yes, please choose the Bank Transfer/Cheque/PayNow option during checkout and we will send you an invoice.
Q: May I self collect?
A: We are all in the middle of a pandemic. We cannot accept walk in customers. Let’s stay safe and choose the free delivery option instead.
Q: Are the buffers prefilled? Or does the user have to pour the buffer into the buffer tube?
A: The buffers are sealed individually and prefilled. No transferring of buffer is needed
Q: May I have the MSDS?
A: Download MSDS