Kit ini merupakan reagen utama untuk mendeteksi virus COVID-19. Kit ini mendeteksi gen ORF1ab dan N dari SARS-CoV- 2 pada sampel.

This kit is used for in vitro qualitative detection of novel coronavirus (SARS-CoV-2) ORF1ab and N gene in samples, including nasopharyngeal swab, oropharyngeal swab, bronchoalveolar lavage fluid and stool, for diagnosis of the COVID-19 infection, the suspected cluster cases and of the patients who need differential diagnosis of COVID-19 infection.

• 48 test/box
• The limit of detection for the kit is: 200 copies/mL
• COVID-19 Test Kit
• SARS-CoV-2 Test Kit(Real-time PCR)-Liquid
• Included PPN 10%

Principle of the Procedures

This kit used a multiplex Taqman probe-based one-step reverse transcription polymerase chain reaction (RT-PCR), which enables simultaneous qualitative detection of ORF1ab and N gene of SARS-CoV-2 as well as a non-human internal control (Armored RNA for SUC2) in one reaction.

Instrument

The kit can be operated by the real-time PCR thermal cycler with FAM, HEX and ROX detection channels. Among them, SLAN96S, SLAN 96P, ABI7500, LightCycler 480 and Bio-Rad CFX96 is highly recommended. ABI StepOne, StepOne Plus, ABI 7500fast, ABI QuantStudio™ series, Mx3000P/Mx3005P, LightCycler 96 and Rotor-Gene series need to be tested prior to use.

Repeatability

The precision references were tested, the results were all SARS-CoV-2 positive, and the CV of Ct values is no higher than 5%.

Specificity

• Cross-reaction: human genomic DNA and a total of 29 other pathogens (Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Cryptococcus, Citrobacter, Serratia marcescens, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Acinetobacter baumannii, Candida albicans, Streptococcus pyogenes, Streptococcus salivarius, Streptococcus oralis, Influenza A virus H1N1 – 2009, Influenza A virus H3N2, Influenza B Virus Yamagata, Influenza B Virus Victoria, Respiratory syncytial A virus, Respiratory syncytial B virus, Coronavirus OC43, Coronavirus NL63, Coronavirus 229E, Coronavirus HKU1, Parainfluenza virus (type I), SARS, MERS and adenovirus) were tested, and there were no cross-reaction.
• Interference test: the common interfering substances in the samples, such as Oxymetazoline, Dexamethasone, Zanamivir, Mupirocin, etc, have no effect on the test results.