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Specifications

Intended Use Real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in individuals suspected of COVID-19 infection.

Who Can Perform Testing
CLIA-certified laboratories qualified to perform high complexity tests.

Time to Result
Approximately 2-4 hours

Sample Types Oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens, bronchioalveolar lavage (BAL), tracheal aspirates, and sputum.

Probe Targets Two SARS-CoV-2 genome targets in RdRp, one target in N.

Limit of Detection 500 copies per mL

Controls
Internal Control — Human β-globin gene
Positive Control — N gene, RdRp gene; Human β-globin gene
Negative Control — DEPC-treated demineralized water

Components 1100µL Reaction Mixture — Reverse transcriptase, DNA polymerase, RNase Inhibitor, DW

550µL Primer/Probe mix
50µL Positive Control — N gene & RdRp gene plasmid, Human β-globin gene plasmid
500µL Negative Control — DEPC-treated demineralized water

Storage & Handling
Store at –20°C; Use within 3 months of opening; Thaw reagents except Enzyme Mix at room temperature before use; Place all reagents on ice once thawed during entire test procedure; Place Enzyme Mix on ice during entire test procedure; Avoid excessive freeze/thaw cycles; Vortex and spin down reagents before each use.

Sample Collection Kit (Recommended)

• Viral Sample Collection Kit by Noble Bio (Cat. No. UTNFS-3B-1)
• BDTM Universal Viral Transport System by BD (Cat. No. 220531) for collection and transport of upper respiratory tract samples.
• Sputum Collection Container: Sterile Container with Screw Cap by BD (Cat. No. 90004-118) for collection of sputum samples.

RNA Extraction Kit (Required)

• QIAamp DSP Viral RNA Mini Kit by Qiagen (Cat. No. 61904)

PCR Instruments (Required)

• ThermoFisher Applied Biosystems 7500 Real-Time PCR Systems

• Bio-Rad CFX96 Dx Real-Time PCR Detection Systems
• Hongshi SLAN-96P System

Manuals and Instructions