The QuantiVirus™ SARS-CoV-2 Multiplex Test Kit is based on Real-Time PCR (RT-PCR) technology, developed for high throughput and specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, sputum and saliva. The sensitivity reaches 50 copies per mL of SARS-CoV-2 viral with a 95% confidence. Clinical validation of the assay showed 95% sensitivity and a specificity of 100%, with no cross- reaction to different types of non-SARS-CoV-2 species.
- High Sensitivity: Detects as low as 50 copies of viral RNA /mL sample, enables early virus detection and diagnosis.
- High Throughput: Up to 93 clinical samples can be tested on one 96-well plate; up to 381 clinical samples can be tested on one 384-well plate.
- High Specificity: Proven by in silico analysis as well as wet lab testing.
- Intended Sample Types: Easy sampling with saliva in addition to NP, OP, and sputum, overcoming short supply of swabs.
- Minimal Sample Input: as low as 2 to 5.5 μL sample needed.
- Ease of Use: Only one reaction mix needs to be set up per sample.
- Fast Turnaround Time: Only 2 hours from nucleic acid extraction to results.
- Flexibility: Assay validated on widely used qPCR instruments including ABI 7500 Fast Dx, ABI QuantStudio 5 and BioRad CFX 384.
- Precision: Coefficient of variation (CV) < 3%, allowing reproducible test results