Real-time PCR Kit for Rapid Detection of Novel coronavirus (SARS-CoV-2)

[Packaging specifications]
50 tests/kit、100tests/kit
50 person piece size：70*45*55mm
50 person piece weight: 0.026kg
50 tests/kit,One box size (100 boxes)：290*235*285mm
50 tests/kit,One box weight (100 boxes)：3.2kg

【Detection Principle】
This kit is based on one-step RT-qPCR technique, Novel Coronavirus (SRAS-COV-2) ORF1ab and N gene are selected as amplification targets, and specific primers and fluorescent probes are designed for the detection of Novel Coronavirus (SRAS-COV-2) RNA in samples (ORF1ab gene probe labeled with FAM and N probe labeled with HEX). The kit also includes an endogenous internal standard detection system (the internal standard gene probe is labeled by Cy5), which is used to monitor the process of sample collection, nucleic acid extraction and PCR amplification, and can reduce the occurrence of false-negative results. The human RNase P gene is used as the internal standard.

【Expected Usage】
This product is a kit for rapid nucleic acid detection of novel coronavirus (COVID-19) based on fluorescent quantitative PCR probe method with specific primers and fluorescent probes designed according to ORF 1ab gene and N gene of novel coronavirus (COVID-19). At the same time, UDG system can effectively prevent cross-contamination of PCR products.When used, only adding template, primer-probe mixture and water can carry out the test reaction, which greatly simplifies the operation process and reduces the error in the PCR operation process

【Test Method】
1. Reagent preparation (reagent preparation area)
2. Sample processing (sample processing area)
3. PCR amplification detection (nucleic acid amplification region)
4. Analysis of results

【Interpretation of Test Results】
1. Negative and positive control materials should be tested in each experiment. Only when the control materials meet the quality control requirements can the test results be determined;
2. When the FAM and VIC detection channels are positive, the result from the Cy5 channel (internal standard channel) may be negative due to the competition of the system;
3. When the internal standard result is negative, if the FAM and VC detection channels of the test tube are also negative, it indicates that the system is inhibited or the operation is wrong, the test is invalid. Therefore, the sample needs to be re-tested;

4. The report is recommended to be in the following format:
The format of negative result report: no 2019 Novel Coronavirus (SRAS-COV-2) RNA was detected in the specimens, and the concentration was lower than the sensitivity of the kit;
The format of the positive result report: 2019 Novel Coronavirus (SRAS-COV-2) RNA was detected in the specimens.