Specification: | 50 Tests | Storage Temperature: | -20 ℃±5℃ |
---|---|---|---|
Shelf Life: | 12 Months | Sample Type: | Saliva |
Application: | Detect COVID Delta | Downstream Application: | DdPCR, |
Methodology: | PCR, | Target: | ORF1ab, E Gene, RNase P |
Processing: | Semi-automatic | Time Per Run: | 30-60 Minutes |
PCR Reaction Solution Volume: | 14 μL | PCR Enzyme Mix Volume: | 1 μL |
Reaction Mix Volume: | 15 μL | Positive Control Volume: | 10 μL |
Negative Control Volume: | 10 μL | PCR Reaction Plate: | 48-well, 96-well, 192-well, 384-well |
Supporting Platform: | Bio-Rad CFX 384;Biosystems PCR 7500;Agilent Mx3000P QPCR System Eppendorf Mastercycler X50 PCR Cycler | Reference Range: | Ct>40 |
LoD: | 500 Copies/ ML | CV: | <5% |
PPA: | >95% | NPA: | >95% |
Specificity: | >99% | Detection Rate: | >85% |
Production: | GMP Production | Quality System: | ISO13485: 2016 |
OEM/ODM: | Support | ||
High Light: | 50 tests Covid 19 PCR Test,IVDR Covid 19 PCR Test,Molecular Diagnostic saliva antigen test kit |
COVID-19 Antigen Nucleic Acid Detection Kit (qRT-PCR) for Molecular Diagnostic (saliva)
Product info
Product name | Specification |
COVID-19 Antigen Nucleic Acid Detection Kit (qRT-PCR) for Molecular Diagnostic (saliva) | 50 tests |
Product description
This kit is used for in vitro detection of viral RNA of novel coronavirus (SRAS-COV-2) ORF1ab and E genes in the oropharyngeal swab, nasopharyngeal swab and sputum from individuals who are suspected of COVID-19 by their healthcare provider, who are among cluster of COVID-19 cases, or who have other diagnostic needs determined by their healthcare provider.
This kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques required for performing the test and in vitro diagnostic procedures.
Core advantage
Our COVID-19 Antigen Nucleic Acid Detection Kit (qRT-PCR) for Molecular Diagnostic (saliva) is targeted at ORF1ab, RNase P and E gene (based upon latest research from US FDA, COVID Omicron has mutation in N genes and S genes, and significantly lower the detection rate of the kits which target on these genes). But so far, there is no evidence to show that E gene has mutation occurred in Omicron. Therefore, our test kit can detect COVID Omicron as efficient as COVID Delta, Alpha, etc.
Parameter
Component
Component Name |
Specifications (50 reactions/kit) |
Quantity | Main Composition |
SARS-CoV-2 PCR Reaction Solution | 700ul/vial | 1 vial | Primers, probes, dNTP, MgCl2, etc. |
SARS-CoV-2 PCR Enzyme Mix |
50μl/vial | 1 vial | Reverse transcriptase, DNA polymerase, RNase inhibitor, uracil-N-glycosylase, etc. |
Positive Control | 600μl/vial | 1 vial | Virus-like particles of SARS-CoV-2 |
Negative Control | 600μl/vial | 1 vial | Nuclease-free water |
Storage condition
The kit should be stored at -20±5℃ in dark and is stable for 12 months. Repeated freeze-thaw cycles should be avoided. See the product label for the date of manufacture and expiration of the kit.
Workflow
Applicable Instrument
Agilent Mx3000P qPCR System
Eppendorf Mastercycler X50 PCR Cycler