COVID-19 new variants (23rd May 2024)
23rd May 2024
The wet lab study analysis on the KP.1 and KP.2 strains, which are descendants of the JN.1 variant (an offshoot of the Omicron variant), has been completed and submitted to the Health Sciences Authority (HSA). The results indicate that Flowflex maintains the same sensitivity in detecting the KP.1 and KP.2 strains. Users of Flowflex can be assured that our ART kits meet the regulatory requirements in Singapore, ensuring reliable detection of these new variants.
18 December 2023 Update
The wet lab study analysis on the JN.1 variant, a sublineage of BA.2.86 Subvariant, has been completed and been submitted to Health Sciences Authority (HSA).
22 August 2023 Update
The wet lab study analysis for the Omicron EG.5 Subvariant has been completed and submitted to MOH. The result shows that Flowflex has the same sensitivity in detecting the Omicron EG.5 Subvariant.
31st October 2022 Update
The wet lab study analysis for the Omicron XBB Subvariant has been completed and submitted to MOH. The result shows that Flowflex has the same sensitivity in testing the Omicron XBB Subvariant. As a result, users of Flowflex can be assured that Flowflex has met regulatory requirements in Singapore on the ART ability to detect Omicron XBB Subvariant.
10th October 2022 Update
The wet lab study analysis for the Omicron variant BA.2.75 or “Centaurus” has been completed. The result shows that Flowflex has the same sensitivity in detecting the Omicron variant BA.2.75.
17th May 2022 Update
The wet lab study analysis for the Omicron BA.4 and BA.5 sub-variant has been completed. The result shows that Flowflex has the same sensitivity in testing the omicron sub-variant.
7th April 2022 Update
The wet lab study analysis for the Omicron BA.2 sub-variant has been completed and submitted to MOH. As a result, users of Flowflex can be assured that Flowflex has met regulatory requirements in Singapore on the ART ability to detect BA.2.
4 Feb 2022 Update
Geneva University Hospital has performed a comparison of the performance of the FlowFlex ART against several other brands including Standard Q and Panbio using clinical specimens with Omicron and Delta Variants.
FlowFlex has a sensitivity of 91.2% against Delta and 88.9% against Omicron variant.
Panbio has a sensitivity of 67.7% against Delta and 36.1% against Omicron variant.
Standard Q has a sensitivity of 52.9% against Delta and 22.2% against Omicron variant.
Source: https://www.medrxiv.org/content/10.1101/2021.12.18.21268018v2.full.pdf
25 Jan 2022 Update
BA.2 newly detected version of Omicron continues to spread around the world. Like the more familiar version of Omicron, BA.2 has a large number of changes -- about 20 --concentrated in the spike protein, the part of the virus that's targeted by vaccines.
Unlike Omicron BA.1, however, it doesn't cause a certain signature on lab tests called an s-gene target failure, meaning it can look like other SARS-CoV-2 variants on a first screen. That has some calling it "the stealth variant."
Clinical studies for both BA.1 and BA.2 have been completed and submitted to MOH. Users of the FlowFlex ART are assured that Omicron variants do not have an impact on the performance of the ARTs.
10 Dec 2022 Update
Wet lab study for Omicron variant (B.1.1.529 or BA.1) has been completed and submitted to MOH. As a result, users of the FlowFlex can be assured that the FlowFlex has fulfilled regulatory requirements in Singapore.
29th Nov 2022 Update
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.