A*STAR Fortitude 2.0 COVID-19 Real-Time RT-PCR Test

A*STAR FORTITUDE KIT 2.0 is an in-vitro diagnostics (IVD) test kit under Provisional Authorization (MDPA2020-01) issued by Singapore’s Health Sciences Authority (HSA).

A*STAR FORTITUDE KIT 2.0 is based on real-time RT-PCR technology, for the qualitative detection of SARS-CoV-2 specific RNA. The assay includes a positive control and an internal control.

Real-time RT-PCR technology utilizes reverse-transcriptase (RT) reaction to convert RNA into complementary DNA (cDNA), polymerase chain reaction (PCR) for the amplification of specific target sequences and target specific probes for the detection of the amplified DNA. The probes are labelled with fluorescent reporter and quencher dyes.

The SARS-CoV-2 assay recognizes one single target region on the SARSCoV-2 viral sequence.

The probes specific for SARS-CoV-2 RNA are labelled with the fluorophore FAM. The probe specific for Internal Control (IC) is labelled with the fluorophore HEX. Using probes linked to distinguishable dyes enables the parallel detection of SARS-CoV-2 specific RNA, as well as the detection of the Internal Control in corresponding detector channels of the real-time RTPCR instrument.

The test consists of three processes in a single assay:
o Reverse transcription of target RNA to cDNA o PCR amplification of target and Internal Control DNA o Simultaneous detection of PCR amplicons by fluorescent dye labelled probes