CE Certification Rapid Diagnostic Test Factory – COVID19-Omicron – Aehealth

The kit is used for in vitro qualitative detecting the ORF1ab/N/S genes of novel coronavirus 2019-nCoV in respiratory specimens including oropharyngeal swabs, nasopharyngeal swab, sputum and
bronchoalveolar lavage fluid, and performing mutation typing on HV69-70 del simultaneously. As reported in GISAID database, more than 95% Omicron variant sequences reported include a deletion in the HV69-70, which can cause an S gene target failure (SGTF) in PCR assays. SGTF can be used as a proxy marker to screen for Omicron.

Primer sets and FAM labeled probe are designed for specific detection of ORF lab gene of 2019-nCoV, VIC labeled probe for N gene of 2019-nCoV, ROX labeled probe for S gene HV69-70 del mutation of 2019-nCoV. Human RNase P gene extracted concurrently with the test sample provides an internal control to validate nucleic extraction procedure and reagent integrity. Probe targeting human RNase P gene is labeled with CY5.

Accuracy

Endogenous control (RdRp gene) included for sample extraction;

Specificity

Preventing contamination using the UDG(Uracil-DNA Glycosylase System);

Sensitivity: 200 copies/mL;

Efficiency

Optimized reagent system, simple components, saving detection time;
Compatible with multiple brands of PCR instruments;

Reliable

Repeatable and reproducible results;
No cross-reactivity with other respiratory viruses;

Real-Time PCR System: Aehealth Diagenex AL, ABI 7500, ViiATM 7, Quant Studio 7 flex.Roche Lightcycler 480, Agilent Mx3000P/3005P, Rotor-GeneTM6000/0. Bio-Rad CEX96 TouchTM SLAN-96S.SLAN-96P, MA 6000;