Q-POC

The Q-POC™ Severe Acute Respiratory Syndrome Virus Coronavirus-2 (SARS-CoV-2) Assay is a qualitative, real-time reverse transcription polymerase chain reaction (rtRT-PCR) assay for the detection of SARS-CoV-2 genomic RNA from upper respiratory specimens (e.g. nasal mid-turbinate swabs) collected from individuals who meet criteria for SARS-CoV-2 testing. The Q-POC™ SARS-CoV-2 Assay is a qualitative assay. The Q-POC™ SARS-CoV-2 Assay test cassette contains lyophilised reagents comprised of all components required for rtRT-PCR amplification and detection of genomic RNA from SARSCoV-2 virus, a Specimen Process Control (SPC) and a reagent Rehydration Control.

Assay specifications:

• Specimen: Nasal mid-turbinate
• Time to results: 30 min
• Hands-on time: 1 min
• LoD: 50 copies/rxn
• Targets: SARS-CoV-2 Orf1, N and S genes
• Store: Collection kits and cassettes at 0-25°C
• Control: Sample process control and rehydration control
• External control: Q-POC™ SARS-CoV-2 Controls

The Q-POC SARS-CoV-2, Flu A/B & RSV Assay is a single-use disposable test cassette to be processed by the Q-POC instrument to result in rapid automated qualitative real-time reverse transcriptase-polymerase chain reaction (rtRTPCR) for the detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV genomic RNA from nasal mid-turbinate, and nose and throat, specimens collected from individuals suspected of respiratory viral infection by their healthcare provider

The Q-POC SARS-CoV-2, Flu A/B & RSV Assay is run on the Q-POC instrument, automating nucleic acid release, amplification and detection of nucleic acid from biological samples. The qualitative rtRT-PCR assay targets the Orf1, N and S genes of SARS-CoV-2, the matrix protein of Flu A, the nonstructural protein of Flu B, and the nucleoprotein and matrix protein of RSV, well conserved regions of the viruses. It also runs a Specimen Process Control (SPC) to ensure sufficient sample collection and proper functioning of the test.

Assay specifications:

• Specimen: mid-nasal or nose & throat sample
• Hands-on time: 1 min
• Time to results: 35 min
• LoD:    SARS-CoV-2: 250 copies/ml    Flu A: 1000 copies/ml        Flu B: 1250 copies/ml       RSV A: 4000 copies/ml       RSV B:1500 copies/ml   
• Targets: SARS-CoV-2: Orf1, N and S genes       Flu A Matrix protein      Flu B Nonstructural protein      RSV Nucleoprotein; matrix protein
• Store: Collection kits and cassettes at 0-25°C
• Control: Specimen Process Control
• External control: Q-POC™ SARS-CoV-2 Controls

The Q-POC™ SARS-CoV-2 Positive and Negative Controls have been formulated for use with the QuantuMDx Q-POC™ System consisting of the Q-POC™ instrument and Q-POC™ SARS-CoV-2 Assay disposable test cassette. The Q-POC™ SARS-CoV-2 Positive Control consists of purified intact viral particles(Isolate: USA-WA1/2020) which have been chemically treated to render them non-viable, and human A549 cells. The Q-POC™ SARS-CoV-2 Negative Control contains purified human A549 cells. The control pack contains 1 x 250 µL vials of each Q-POC™ SARS-CoV-2 Positive and Negative control.