Several NAATs exist and they are principally designed to detect genetic material (nucleic acids)

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]

Test Totally authorized* Method Crizotinib hydrochloride rowspan=”1″>Example# Assay name Specimen SARS-CoV-2 target Detection Instrument Assay time Setting LoD

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.

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