COVID-19 Coronavirus Real Time PCR Kit

Introduction

COVID-19 Coronavirus Real Time PCR Kit is an In Vitro Diagnostic (IVD) reagent applying on fluorescent PCR technology and aiming at qualitatively detect Open Reading Frame gene region (ORF1a/b) and viral nucleocapsid region (N) of SARS-CoV-2 RNA from upper and lower respiratory tract specimens.
Upper respiratory tract specimens include throat swab and nasopharyngeal swab. Lower respiratory tract specimens include sputum.
The product is intended for use on populations suspected to have SARS-CoV-2 infection, as an aid in the diagnosis of SARS-CoV-2 infection by trained laboratory personnel on RT-PCR.

Features

Multiplex real-time PCR detect different target specific for SARS-CoV-2
Internal control ensures the whole process reliably
Better performance makes the result more accurate
More efficient: 96 tests in 72 minutes (on an instrument)
Suitable for more mainstream instrument
Shelf life: 12 months

Parameters

Target	ORF1a/b, N genes and RNaseP as IC
Clinical Sensitivity	100%
Clinical Specificity	99.8%
Limit of detection	350 copies/mL
Sample input volume	5μL
Sample type	Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage (BAL) fluid and sputum specimens.