VitaPCR^TM platform

The VitaPCR™ SARS-CoV-2 Assay is a rapid molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the qualitative detection of SARS CoV2 viral RNA in nasopharyngeal (NP) or oropharyngeal (OP) swabs.

• The assay includes an endogenous RNA amplicon to control all the phases of the process from sampling to amplification.

Assay Specifications

• Specimen: NP/OP SWABS
• Time to results: 20 min
• Eluted specimen storage: +2°C/+8°C up to 10 hours
• Viral inactivation: yes
• LoD: 90 copies/reaction (3 copies/uL SCB)
• Targets
  1) SARS-CoV-2 specific region located in N gene
  2) SARS-like conserved region located in N gene
• Control: Assay for Betaglobin human gene transcript

The VitaPCR™ Flu A&B Assay is a rapid qualitative molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs .

Assay Specifications

• Specimen: nasal (NS) or nasopharyngeal (NP) swabs
• Time to results: 20 min Eluted specimen storage: +2°C/+8°C up to 7 days
• Targets
  1) Influenza A: conserved region of matrix gene (M gene)
  2) Influenza B: conserved region of non-structural protein gene (NS gene)
• Control Synthetic RNA Internal Control

The VitaPCR™ Flu A&B – SARS CoV-2 panel assay is a rapid molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the detection and differentiation of Influenza A, Influenza B and SARS COV-2 in nasopharyngeal swabs.

Assay Specifications

• Specimen: nasopharyngeal (NP) swabs
• Time to results: 20 min
• Eluted specimen storage: +2°C/+8°C up to 7 days
• Targets
  1) Influenza A: conserved region of matrix gene (M gene)
  2) Influenza B: conserved region of non-structural protein gene (NS gene)
  3) SARS COV-2: nucleoprotein gene (N gene)
• Control Synthetic RNA Internal Control

The VitaPCR™ Flu A&B – RSV panel assay is a rapid molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the detection and differentiation of Influenza A, Influenza B and Respiratory Syncytial Virus in nasal and nasopharyngeal swabs.

Assay Specifications

• Specimen: nasal (NS) or nasopharyngeal (NP) swabs
• Time to results: 20 min
• Eluted specimen storage: +2°C/+8°C up to 7 days
• Targets
  1) Influenza A: conserved region of matrix gene (M gene)
  2) Influenza B: conserved region of non-structural protein gene (NS gene)
  3) RSV: conserved region of nucleocapsid protein gene (N gene)
• Control Synthetic RNA Internal Control

The VitaPCR™ Strep A Assay is a rapid qualitative molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the detection of Streptococcus pyogenes (Group A β hemolytic Streptococcus, Strep A) in oropharyngeal (OP) or throat swabs.

Assay Specifications

• Specimen: oropharyngeal (OP) or throat swabs
• Time to results: 20 min
• Eluted specimen storage: +2°C/+8°C up to 14 days
• Targets
  1) Group A Streptococcus: conserved region of spy1258 gene
• Control Synthetic RNA Internal Control

The VitaPCR™ SARS-CoV-2 Gen2 Assay is a high sensitivity, second generation rapid molecular diagnostic assay utilizing Real-Time PCR (RT-PCR) amplification technology for the qualitative detection of specific SARS-CoV-2 RNA in respiratory specimens collected via nasopharyngeal (NP) or oropharyngeal (OP) swabs.

• Specimens eluted in the Gen2 sample collection buffer can be stored up to a week at 4C°.

Assay Specifications

• Specimen: NP/OP SWABS
• Time to results: 20 min
• Eluted specimen storage: +2°C/+8°C up to 7 days
• Viral inactivation: yes
• LoD: 30 copies/reaction (1 copy/uL SCB)
• Targets:
  1) SARS-CoV-2 specific region located in N gene
  2) SARS-like conserved region located in N gene

Control: Synthetic RNA Internal Control