COVID 19 Nucleic Acid Oropharyngeal Swab Coronavirus Test Kit

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit

(PCR-Fluorescence Probing)

Intended Use

Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is used for qualitative detection of the ORF1ab and N genes of novel coronavirus(2019-nCoV) in nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, sputum, serum, whole blood and feces from suspected pneumonia cases with novel coronavirus infection, patients with suspected clusters of novel coronavirus infection, and other patients requiring diagnosis or differential diagnosis of novel coronavirus infection.

For in vitro diagnostic use only. For professional use only.

Summary

The definitions of "suspected cases" and "suspected clusters of patients" shall be defined by referring to the "Pneumonia Diagnosis and Treatment Program for Novel Coronavirus Infection" and "Pneumonia Case Monitoring Program for Novel Coronavirus infection" issued by China CDC (the currentversion).

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit(PCR-Fluorescence Probing) is only used for the auxiliary diagnosis of related cases and the emergency reserve for in vitro diagnosis during the pneumonia outbreak of novel Coronavirus (2019-nCoV) infection since December2019, this kit shouldn’t be used as routine in vitro diagnostic in clinical practice. Please follow the relevant requirements of the "Pneumonia Diagnosis and Treatment Program for Novel Coronavirus Infection", "Pneumonia Prevention and Control Program for Novel Coronavirus infection" and other documents in use.

The novel Coronavirus nucleic acid tests should comply with“Technical Guidelines for Laboratory Testing of Novel Coronavirus in China CDC” and keep good biosafety.

Components of the Diagnostic Kit

This kit is an amplification reaction reagent and contains the following components:

Note:

1. Do not mix or exchange components from different kit lots.

2. All biological samples in the diagnostic kit have been inactivated.

3. Materials required but not provided: 1.5ml DNase-free and RNase-free centrifuge tubes, 0.2ml PCR reaction tubes, pipette tips(10μL, 200μL and1000μL tips with filters are preferred), desktop centrifuge, desktop vortex mixer various models of pipette guns.

4. Self-prepared reagent: Sample Release Reagent( Reference Number: S1014E) or Sample Release Reagent( Reference Number: S1015E) or Nucleic Acid(DNA/RNA) Extraction or Purification Kit(Magnetic beads method) ( Reference Number: S1002E) manufactured by Sansure Biotech Inc. or QIAamp Viral RNA Mini Kit(50) manufactured by QIAGEN. Sample Storage Reagent, such as Sample Storage Reagent(Reference Number:X1002E) manufactured by Sansure Biotech Inc.

Quality Control

The test result is treated as valid if all the conditions in the above-mentioned are met for the same test. Otherwise the test result is treated as invalid and needs to be re-tested.

Reference Range

Through the research on reference values, the Ct reference value of target gene is determined to be 40, the Ct reference value of internal control is determined to be 40.

Explanation of Detection Result

There is no typical S-shape amplification curve detected at FAM, ROX and HEX channel (No Ct), or Ct > 40. It is indicated that the specimen's concentration is too low, or there are interfering substances that inhibit the reaction. The test result is invalid. An investigation should be performed to find out and exclude the reasons, please collect specimen again and retest the specimens.

Storage and Stability

1. The diagnostic kit should be stored in a sealed pouch at-20±5°C and protected from light. The kit is provisionally valid for 6 months.

2. Please refer to the date of manufacture and expiry date on the outer package.

3. The reagents keep valid and stable within the expiry date if not used. As long as the container of the reagent is opened, the freeze/thaw cycles should not exceed three.