Health professionals doing collection and testing of suspected COVID-19 cases are reporting that the process is needed to be repeated on patients, as results are coming back negative when the health professional is almost certain the patient has contracted the virus.This high false-negative rate might be due to a couple of factors:

1. Low viral loads or unsuitable collection
2. Handling and/or storage of nasopharyngeal aspirate/swabs or throat swabs 
3. Failure of the extraction, purification, reverse transcription or amplification of COVID-19.

Now, as countries are hurrying to buy stocks of tests from China in bulk, the validation step on these tests and need to avoid false negatives is of utmost importance. Part of the testing process requires the extraction of RNA from the specimen, be it bronchoalveolar lavage (BAL), sputum, or on a nasopharyngeal or oropharyngeal swab.  How can you be sure that the qPCR mix which converts RNA to cDNA and the polymerase that amplifies the nucleic acids is working 100%?

Meridian’s VLP-RNA Extraction Controls offers a simple and effective way to reduce false-negative results in RT-qPCR assays. The controls are composed of virus-like particle (VLP) shells packaged with a defined number of copies of target RNA molecules that contain no known homology (the RNA sequence can also be customized up to 1000nt).

By closely mimicking a diagnostic sample, these controls enable labs to test the entire process of an RT-qPCR assay including lysis/ extraction, reverse transcription and amplification. This positive control can identify true negative from false-negative results, caused by inhibition, nucleic acid degradation, sample processing error or thermocycler malfunction.