June 8, 2020

Covid-19 testing landscape

COVID-19 diagnostics in context

This is the best summary of current supply of diagnostic tests for Covid-19:
COVID-19 tests can be grouped as nucleic acid, serological, antigen, and ancillary tests, all of which play distinct roles in hospital, point-of-care, or large-scale population testing.
Table 1 summarizes the existing and emerging tests, current at the time of writing (May 2020). A continuously updated version of this table is available at https://csb.mgh.harvard.edu/covid
Eric Topol says:
There are now *88* @US_FDA  cleared (by EUA) #COVID19 tests so far. Their false negative rates range from 10-48% (by post-release reports).
Might be better to have less tests, more accuracy, with faster turnaround
I agree.

Table 1 Performance comparison of different test types.
Throughput is determined by process type and assay time. In general, automated plate-based assays have higher daily throughputs. Hashtag (#) indicates example systems that have received FDA emergency use authorization (FDA-EUA). See https://csb.mgh.harvard.edu/covid to access continuously updated information. PCR, polymerase chain reaction; PCR-POC, PCR–point-of-care; ddPCR, digital droplet PCR; NEAR, nicking endonuclease amplification reaction; RCA, rolling circle amplification; SHERLOCK, specific high-sensitivity enzymatic reporter; DETECTR, DNA endonuclease-targeted CRISPR transreporter; NGS, next-generation sequencing; μNMR, micro–nuclear magnetic resonance; LFA, lateral flow assay; ELISA, enzyme-linked immunosorbent assay; CLIA, chemiluminescence immunoassay; EIA, enzyme immunoassay; ECLIA, electrochemiluminescence immunoassay; ECS, electrochemical sensing; VAT, viral antigen assay; IFM, immunofluorescence microscopy; WB, Western blot.

TypeTargetVirusAssay timeProcess typeFDA-EUAExamples
PCRViral RNASARS-CoV-22–8 hours; >12 hoursPlate56#Roche, #LabCorp,
#Becton Dickinson,
#Luminex, #Thermo
Fisher, others
PCR-POCViral RNASARS-CoV-2<1 hour="" td="">Cartridge2#Cepheid, #Mesa,
ddPCRViral RNASARS-CoV-22–4 hoursManual1#BioRAD
NEARViral RNASARS-CoV-215 minCartridge1#Abbott
OMEGAViral RNASARS-CoV-21 hourPlate1#Atila BioSystems
RCAViral RNASARS-CoV2 hours0
SHERLOCKViral RNASARS-CoV-21.5 hoursKit1#Sherlock
DETECTRViral RNASARS-CoV-21 hourKit0Mammoth
NGSViral RNASARS-CoV-2Days1#IDbyDNA, Vision,
μNMRViral RNASARS-CoV-22 hoursCartridge0T2 Biosystems
LFAIgG, IgMSARS-CoV-215 minCartridge3#Cellex,
#ChemBio, Innovita
ELISAIgG, IgMSARS-CoV-22–4 hoursPlate4#Mount Sinai,
#Ortho-Clinical (2),
Inc., BioRAD, Snibe,
Zhejiang orient,
Creative Dx
CLIAIgG, IgMSARS-CoV-230 minCartridge2#Abbott, #DiaSorin
EIAIgG, IgMSARS-CoV-22 hoursPlate1#BioRAD
MIAIgG, IgMSARS-CoV-2Plate1#Wadsworth Center
ECLIAIgG, IgMSARS-CoV-220 minPlate1#Roche
ECSIgG, cytokineSARS-CoV-21 hourCartridge0Accure Health
VATViral antigenSARS-CoV-220 minCartridge1#Quidel, Sona NT,
RayBiotech, SD
Biosensors, Bioeasy
MicroarraysIg epitopesSARS-CoV-21.5 hoursPlate0RayBiotech,
IFMViral proteinSARS-CoV3 hoursManual0
WBIgG, IgM; viral proteinSARS-CoV4 hoursManual0