Several NAATs exist and they are principally designed to detect genetic material (nucleic acids). the successful detection of SARS-CoV-2 from specimens while protecting laboratory workers and non-suspecting individuals from becoming infected. From this review article, it is obvious the SARS-CoV-2 pandemic offers led to an increase in molecular diagnostic tools and the formation of fresh biosafety protocols that may be important for future and ongoing outbreaks. SARS-CoV-2 diagnostic tests by the US FDA includes 262 molecular checks, 32 antigen-based checks, and 88 serology and additional adaptive immune response checks. With this section, we focus on some of these molecular diagnostic checks including NAATs, RDTs, and IATs. Table 2 Examples of recently authorized molecular diagnostic checks for SARS-CoV-2 by the US FDA [11]
RT-qPCR207RT-PCRcobas SARS-CoV-2ANS, NS, ANS, NPS, OPSORF1a/b, ECobas (6800/8800)2h 30 minsH, M, H-Pooling46 cp/mlRT-ddPCR3RT-PCRBio-Rad SARS-CoV-2 ddPCR KitNPS, ANS, MNS, NPW/AN1, N2QX200, QXDx6.6 h/96 samplesH625 cp/mlRT-LAMP9IATLucira CHECK-IT COVID-19 Test KitANSNLucira (colorimetric)30 mins/sampleHome, H, M, W2700 cp/swabRT-LAMP, CRISPR2IATSherlock CRISPR SARS-CoV-2 KitNS, NPS, OPS, NPW/A, NA, BALFORF1ab, NMicroplate reader (fluorometric)1 h/runH6750 cp/mlTMA7IATAptima SARS-CoV-2 assayNS, NPS, OPS, MNS, NPW, NPA, NAORF1abPanther fusion (chemiluminescent)2.4 h/runH, pooling0.026 TCID50/mlNEAR1IATID NOW COVID-19NS, NPS, OPSRdRpID NOW (fluorometric)13 min/runH, M, W125 cp/mlRT-HDA1IATSolana SARS-CoV-2 AssayNPS, NSpp1abSolana (fluorometric)30 mins (12 samples)H, M11600 cp/mLSequencing6NGSSARS-CoV-2 NGS AssayNPS, OPS, MNS, ANS, NS/A, NPW/A, BALFEntire viral genomeIllumina NextSeq (500/550/550Dx) 12 hH800 cp/mlAg-based immunoassays32Ag-RDT (e.g. LFIA), ELISA, CLIACareStart COVID-19 Antigen Home TestANSNLFIA strip (visual readout)10-15 minsHome, H, M, W2800 TCID50/mlAb-based immunoassays88Ab-RDT (e.g. LFIA), ELISA, CLIAADVIA Centaur SARS-CoV-2 Total (COV2T)Plasma, serumTotal antibody (Including IgG, IgM)ADVIA Centaur XP (chemiluminescence)10-15 minH, M0.5 index Open in a separate window SARS-CoV-2/COVID-19 C severe acute respiratory syndrome coronavirus 2/coronavirus disease 2019; N(A/S) C Nasal (aspirate/swab); NP(S/W/A) C Nasopharyngeal (swab/wash/aspirate); BALF -Bronchoalveolar fluid; ANS C Anterior nose swab; MNS C Mid-turbine nose swab; OPS C Oropharyngeal swab; LoD C Limit of detection; pp1ab – SARS-CoV-2 non-structural polyprotein; NGS C Next generation sequencing; HDA – Helicase-dependent amplification; CLIA C Chemiluminescence immune assay; ELISA C Enzyme linked immunosorbent assay; LFIA C Lateral circulation immunoassay; Ag C Antigen; Ab C Antibody. * Total number Crizotinib hydrochloride was acquired by entering keywords for the diagnostic checks and methods into the US FDA site search tool on-line 11, 12. #A representative example of the details of how the authorized kits work, this does not apply to additional related assays. H – Laboratories qualified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet the requirements to perform high complexity checks. M – Laboratories qualified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet the requirements to perform moderate complexity checks. W – Patient care settings operating under a CLIA Certificate of Waiver. 3.1. Nucleic acid amplification-based checks (NAATs) NAATs are the method of choice for confirming the presence of SARS-CoV-2 in samples including COVID-19 samples. Several NAATs exist and they are principally designed to detect genetic material (nucleic acids). Briefly, once the genetic material of a specimen is acquired, it is amplified. This amplification aids NAATs to detect small amounts of RNA in specimens leading to increased level of sensitivity [19]. The WHO and CDC recommend that NAATs be used on top and lower respiratory tract specimens [19]. Since the outbreak of COVID-19, many NAATs have gained EUA by companies such as the US FDA. Below we summarize the operating principle of some of Rabbit Polyclonal to RAB3IP these NAATs including RT-PCR and IATs: 3.1.1. RT-Pcr RT-PCR is the current platinum standard detection method for confirmation of COVID-19. Of all the NAATs, real-time reverse transcription quantitative PCR (RT-qPCR) is the most commonly used method for the detection of SARS-CoV-2 and confirmation of COVID-19 [20]. RT-PCR greatly relies on primers and/or probes for detection and since the outbreak, several primer and probe models have been designed for COVID-19 analysis and their level of sensitivity has been identified 21, 22, 23. These primer and probe units target various regions of Crizotinib hydrochloride SARS-CoV-2 including the nucleocapsid (N), envelope (E), and spike (S) genes, as well as.