COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2698

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-12-02 09:22:17 CET

Comments

HA TECH SARS-CoV-2 RT-PCR Multiplex Diagnostic Kit is a real time RT-PCR test intended for the qualitative detection of RNA from the SARS-CoV-2 virus in upper respiratory specimens such as nasopharyngeal swabs, oropharyngeal swabs and saliva. The primers and probes in this assay are designed based on the gene sequences of ORF1ab gene, N gene, and E gene in the 2019 novel coronavirus (SARS-CoV-2) genome. The product is manufactured in Australia and also TGA approved (ARTG 351643) (https://www.tga.gov.au/covid-19-test-kits-included-artg-legal-supply-australia). Also listed in 360dx.com website (CE Mark). https://www.360dx.com/coronavirus-test-tracker-launched-covid-19-tests

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Measurement

Qualitative

Time

45 minutes

LOD

0.8 cpu

Positive control

Positive control (purified SARS-CoV-2 genomic RNA) provides a reverse transcription and PCR contr

Negative control

The NTC is Nuclease-free water and must be included in each assay

Analytical Sensitivity

95 %

Analytical Specificity

100 %

Clinical Sensitivity

96.67 %

Clinical Specificity

100 %