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

  • Regulatory status:RUO
  • Type:RT-qPCR
  • Other names:COVID-19, nCoV, Wuhan Coronavirus
  • Species:Human
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New NFIH001 200 tests (kit)
PubMed Product Details
Technical Data

Type

RT-qPCR

Description

  • 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.
  • 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 PCR instrument.
  • Tested on Bio-Rad CFX96 models
  • qPCR testing for specific RNA in nasopharyngeal swabs samples

Applications

COVID-19, Nasopharyngeal swabs

Storage/Expiration

-25°C to -15°C, Protect from light

Limit of Detection

1×103 copies/ml

Summary

Features

  • For research use only
  • Kit includes Internal Control template, Positive Control and Negative Control
  • qPCR testing for specific RNA in nasopharyngeal swab samples.
  • No cross-reactivity with SARS-CoV, Influenza A H1N1, Influenza A H3N2, Influenza B and MERS-CoV.
  • No false negative has been reported to-date.

Research topic

COVID-19

Summary

The A* STAR FORTITUDE KIT 2.0 is based on real-time reverse transcriptase-polymerase chain reaction (RT-qPCR) 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. Refer to Instruction For Use for details (AW-00032).

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