Mylab Discovery Solutions follows Centers for Disease Control and Prevention (CDC) guidelines while offering PathoDetect 2019-nCoV Detection Kit. Currently functionality of the test is checked against synthetic positive controls. Mylab hasn’t established any regulatory clearance for the test yet, which is obvious scenario in pandemic. Though Public health centers or hospitals that use this test need to validate the test performance in house, Mylab is trying to collect sufficient clinical data for kits utility and reliability and also keeping an eye on any mutations or changes to existing novel coronavirus strain for further validity of the test
2019 Novel Coronavirus (2019-nCoV) is a virus identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. Early on, many of the patients in the outbreak in Wuhan, China reportedly had some link to a large seafood and animal market, suggesting animal-to-person spread. However, a growing number of patients reportedly have not had exposure to animal markets, indicating person-to-person spread is occurring. The outbreak has rapidly evolved affecting other parts of China and outside the country. Cases have now been detected in several countries in Asia, but also in Australia, Europe and North America. Early detection is very crucial for outbreak control and clinical management.
Intended Use:
PathoDetect 2019-nCoV Detection Kit offers an in vitro diagnostic real time PCR assay for qualitative detection of 2019- novel Coronavirus RNA in respiratory specimens and sera. The kit offers the universal detection of SARS-like coronaviruses and specific detection of 2019-nCoV.
Note: please read disclaimer
PathoDetect 2019-nCoV Detection Kit
Mylab Discovery solutions 2019-nCoV Detection Kit provides ready to use solution for detection of coronavirus using real time PCR technology. Detection is based on the amplification of a specific conserved RNA sequences of coronavirus and detection by Taqman probe based chemistry. An Internal control is detected along with the coronavirus target controlling the extraction efficacy and possible PCR inhibition. The test is designed to use across wide range of PCR platforms. The recommended CDC protocol for coronavirus detection ensures that the kit leads to highly-specific and ultrasensitive results in short time.
Kit Content:
- Reagents for Nucleic acid extraction from respiratory/sera specimens
- Reagents for Real time PCR
- Inclusion of synthetic positive and negative controls
Key Features:
- Design of the kit as per CDC recommended protocol
- Highly Sensitive real time PCR test for novel coronavirus 2019 detection
- Includes all reagent required to perform Sample to Result analysis no additional reagents needed.
- Synthetic Positive controls provided for validity of the test
- Inclusion of internal control for quality check throughout the procedure
- Low contamination risk – no post-PCR product handling
- High-throughput – can screen up to 24 samples in a single run
- Fast – sample to results within two hours
