We began our experiments with the Saliva Direct assay 12, which utilizes the CDCвЂ™s published PCR primers and probes to detect the SARS-CoV-2 N-gene (N1) and human Ribonuclease P (RNase P) in a 96-well format.

To address these shortcomings, the IGI Clinical Laboratory 16 developed a new multiplexed assay with optimized viral and control RNA detection using inexpensive, widely available reagents.ДЄn ideal test would offer affordable and robust detection of multiple SARS-CoV-2 genes and a sample extraction control using a single-well multiplexed format.

Another less-expensive test detects only a single viral locus, which can lead to false-negative results 12, 13 and several tests require 2вЂ“3 separate PCR reactions to yield clinical results 9, 14, 15. One commercially available test entered the scene early, allowing clinical laboratories to rapidly detect multiple viral genes and control RNA in a single reaction however, this test has reported risks of yielding inaccurate results 11 and suffers from supply shortages and high cost. However, variability in test format as well as reagent availability, quality, and cost continue to hamper widespread use for both symptomatic and asymptomatic testing. Quantitative reverse transcription polymerase chain reaction (RT-qPCR) of RNA extracted from nasal swabs is the most common diagnostic testing method to detect SARS-CoV-2 6, 7.Д¬urrent tests rely on the detection of genomic or sub-genomic viral RNA corresponding to the envelope (E) gene, the nucleocapsid (N) gene, the spike (S) gene, and/or the ORF1ab locus 8вЂ“ 10, as well as suitable controls. A vital component of the public health response to slow the spread of the SARS-CoV-2 is diagnostic testing to identify positive patients, followed by isolation and contact tracing 5. One year later, over 63.5 million infections and 1.4 million deaths have been attributed to the virus globally 4. Late in 2019, a novel coronavirus termed SARS-CoV-2 emerged in Wuhan, China and quickly spread across the globe, prompting shelter-in-place and social distancing mandates 1вЂ“ 3.

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