Lab COVID-19 Trust Score
- Manufactured by the Singaporean Government
- Used by the governments of Singapore, Sri Lanka, Indonesia, Burma, China
- Has HSA approval
Introduction: A*STAR Fortitude Kit 2.0 COVID-19 RT-PCR Test
- The kit is co-developed by the Singapore Agency for Science, Technology and Research (A*STAR) Experimental Drug Development Centre, Bioinformatics Institute, The Diagnostics Development (DxD) Hub and Tan Tock Seng Hospital.
- The kit has received Singapore Health Science Authority (HSA) approval (MDPA2020-01) and has been deployed in Singapore public and private hospital labs.
- qPCR testing for specific RNA in nasopharyngeal swab samples.
- No cross-reactivity demonstrated on more than 26 strains of closely related viruses including SARS-CoV, MERS-CoV and Flu etc.
- High sensitivity, with analytical limit of detection (LoD) at 25 copies per reaction.
- The kit is manufactured in Singapore under ISO 13485 QMS.
- Lead scientist has been researching on infectious diseases tests for over 20 years coupled with experience in previous outbreaks.
- As an ‘All-In-One’ 1-step RT-PCR kit for the detection of SARS-CoV-2 RNA. This kit comes complete with all the materials required for the RT-PCR reaction, which includes the primer probes mix, the enzyme mix, the positive control, negative control and internal control template.
- This is a duplex RT-PCR assay which simultaneously detects the SARS-CoV- 2 RNA and the internal control in a single reaction.
- The test takes approximately 90 minutes from extracted RNA to obtaining results.
- Weekly production capacity of more than 100,000 tests.
- In-vitro Diagnostics Test Kit
- 200 reactions/kit
The A*STAR FORTITUDE KIT 2.0 is based on real-time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technology, for the qualitative detection of SARS-CoV-2 specific RNA in nasopharyngeal swab samples. A positive result from the test indicates the presence of SARS-CoV-2 specific RNA in the test sample.
Interpretation of the test results should take other clinical symptoms presented by the patient into consideration. Results of the test should not be taken as the sole means for clinical diagnosis and treatment.
A*STAR FORTITUDE KIT 2.0 should only be used for the intended purpose and in accordance with the Instructions for Use.
Clinical sample type
Extracted RNA from nasopharyngeal swabs.
Targets the NSP-1 gene. From past experience with SARS-CoV and other human coronavirus, this gene exhibits least tendency to mutate, therefore enabling more robust detection of the virus.
There is a continuous effort in the monitoring of potential mutation in the target region. This monitoring effort ensures that assay performance is not affected by potential mis-match between the primers probes and the target sequences. Todate, no mutation has been detected amongst all the more than 200 published gene sequences on GISAID (Global Initiative on Sharing All Influenze Data).
Compatible qPCR platforms:
- BioRAD CFX 96 DX System
- BioRAD CFX 96 TOUCH Real-Time PCR System
- Applied Biosystem 7500 Real-Time PCR System
- Applied Biosystem 7500 Fast Real-Time PCR System
- Roche LightCycler 480 Instrument II
Compatible RNA extraction protocols
This kit has been validated using RNA samples extracted using:
- bioMérieux NucliSens easyMAG automatic total nucleic acid extraction system
- QIAamp Viral RNA Mini Kit
- QIAGEN EZ1 Virus Mini Kit
- QIAGEN EZ1 Advanced
Storage and transportation
This kit is to be transported on dry ice or coolant maintaining -25°C to -15°C and stored at -25°C to -15°C. Protect from light.
- GenomeWeb (03 Mar 2020): Singapore Clears New SARS-CoV-2 Assay for Clinical Use
- The Straits Times (08 Feb 2020): Coronavirus: Made-in-Singapore diagnostics test implemented in hospitals here