Microbiology & infectious diseases
Viruses
COVID-19 (SARS-CoV-2) testing
Editor-in-Chief: Debra L. Zynger, M.D.
Last author update: 8 May 2020
Last staff update: 18 June 2021
Copyright: 2020, PathologyOutlines.com, Inc.
PubMed Search: SARS-CoV-2 [title] diagnostic testing
See Also: COVID-19 convalescent plasma, COVID-19 lung pathology, COVID-19 viral hepatitis
Table of Contents
Definition / general | Clinical features | Essential features of laboratory testing | Testing priorities | Evolution of diagnostic testing | Technology platforms | FDA's list of serological assays that should not be distributed | ICD, CPT and Medicare rate | Diagrams / tables | Board review style question #1 | Board review style answer #1 | Board review style question #2 | Board review style answer #2Cite this page: Wu SC, Tsang P. COVID-19 (SARS-CoV-2) testing. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/microbiologyvirusesdiagtestSARSCOV2.html. Accessed December 26th, 2024.
Definition / general
- Coronavirus disease 2019 (COVID-19) is caused by a single stranded RNA virus belonging to the genus Betacoronavirus
- Causative agent is named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) due to similarities to the virus that caused the SARS epidemic in 2003 (J Microbiol Immunol Infect 2020 Mar 31 [Epub ahead of print])
- Public health emergency declared by the U.S. Secretary of Health and Human Services on January 31, 2020 (CDC: Coronavirus Disease 2019 - Diagnostic Testing [Accessed 24 April 2020])
- Pandemic declared by WHO on March 11, 2020
- Genome likely of bat origin (Proc Natl Acad Sci U S A 2020 Apr 8 [Epub ahead of print])
Clinical features
- Symptoms mostly mild to moderate but can be severe or fatal, especially among the elderly and those with underlying illnesses
- Typical signs and symptoms: fever, cough and dyspnea
- Other symptoms include chills, muscle pain, sore throat and loss of taste or smell
- Incubation period: 2 - 14 days (Cureus 2020;12:e7560)
- Children of all ages are at risk for COVID-19 infection but complications generally appear to be less common than in adults (CDC: Coronavirus Disease 2019 - Information for Pediatric Healthcare Providers [Accessed 19 May 2020])
- Symptoms may be similar to those of common viral respiratory infections, requiring appropriate suspicion for COVID-19 as well as consideration for other infectious etiologies
- A serious multisystem inflammatory syndrome in children (MIS-C) has been reported (up to 21 years of age)
- May present with fever, elevated serum inflammatory markers and multiorgan involvement, such as rash, abdominal pain and myocarditis (NYS DOH: Pediatric Multi-System Inflammatory Syndrome Potentially Associated with COVID-19 [Accessed 19 May 2020])
- Bears similarities with toxic shock syndrome and Kawasaki disease
- Febrile illness characterized by vasculitis
- Manifesting as rash, skin peeling, cervical lymphadenopathy, swelling of the hands & feet and gastrointestinal symptoms
- Elevated interleukin 6 (median 135 pg/mL) and d-dimer (median 5284 ng/mL) in one cohort of 35 MIS-C patients ( Circulation 2020 May 17 [Epub ahead of print])
- MIS-C may begin weeks after infection with SARS-CoV-2
Essential features of laboratory testing
- Emergency use authorization (EUA), put into place by U.S. Congress, allows for expedited Food and Drug Administration (FDA) review (within 24 hours in many cases) based on less stringent validation standards than in nonurgent situations (FDA: Coronavirus (COVID-19) Update - FDA Expedites Review of Diagnostic Tests to Combat COVID-19 [Accessed 24 April 2020])
- Emergency use authorization adoption has led to rapid expansion of testing capacity in the U.S. since mid March, 2020
- Increasing demand continues to outpace assay reagents and supplies
- FDA has provided further flexibility by allowing commercial launch of a diagnostic assay as early as 15 business days prior to emergency use authorization submission as of March 1, 2020 (FDA: Coronavirus (COVID-19) Update - FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics [Accessed 24 April 2020])
- Samples in a laboratory should be handled in a class II or higher biological safety cabinet (FDA: CDC 2019 - Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel [Accessed 24 April 2020])
Testing priorities
- Guidelines for patient testing established by the U.S. Centers for Disease Control (CDC)
- Previously considered “nonpriority”, some asymptomatic individuals are now considered “priority” for testing due to the possibility of asymptomatic infection and viral shedding that can lead to disease transmission
- Guidance updated on May 3, 2020 to test certain asymptomatic individuals as a part of public health surveillance or a mitigation strategy in long term care facilities and other settings (CDC: Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19) [Accessed 18 June 2021])
- Broader testing guidelines reflect the need for more aggressive infection control measures as well as the increased availability of commercial assays, reagents and supplies
- High priority:
- Hospitalized patients with symptoms
- Healthcare facility workers, workers in congregate living settings and first responders with symptoms
- Residents in long term care facilities or other congregate living settings, including prisons and shelters, with symptoms
- Priority:
- Persons with symptoms of potential COVID-19 infection including fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea or sore throat
- Persons without symptoms who are prioritized by health departments or clinicians, for any reason, including but not limited to public health monitoring, sentinel surveillance or screening of other asymptomatic individuals according to state and local plans
- Special considerations for healthcare personnel:
- Testing may be considered if there has been exposure to a person with suspected (not yet confirmed) COVID-19
- Even mild signs and symptoms (e.g., sore throat) of COVID-19 should be evaluated in healthcare personnel who may be potentially exposed, in order to protect vulnerable patients they may come in contact with
- Special considerations for children and young adults with MIS-C
- May represent a post-viral syndrome or cytokine storm caused by body’s immune response
- Incubation period may be up to 4 weeks (longer than that seen in adults with respiratory symptoms)
- Serology testing more likely positive than RT-PCR for SARS-CoV-2 in one small cohort of 10 Italian children (Lancet 2020 May 13 [Epub ahead of print])
- Special considerations for neonates (CDC: Evaluation and Management Considerations for Neonates At Risk for COVID-19 [Accessed 28 May 2020])
- Testing recommended for all neonates born to mothers with confirmed or suspected COVID-19, whether or not there are any signs and symptoms in the neonate or the mother
- RNA testing by RT-PCR on nasopharyngeal, oropharyngeal or nasal swab samples
Evolution of diagnostic testing
- CDC was the first in the U.S. to develop a SARS-CoV-2 diagnostic assay
- Emergency use authorization received on February 4, 2020
- Real time reverse transcriptase polymerase chain reaction (rRT-PCR)
- Gene target: SARS-CoV-2 nucleocapsid (N) gene (FDA: CDC 2019 - Novel Coronavirus (2019-nCoV) Real Time RT-PCR Diagnostic Panel [Accessed 24 April 2020])
- Platform: Applied Biosystems 7500 Fast DX Real Time PCR System (Coronavirus Disease 2019 - Diagnostic Testing [Accessed 24 April 2020])
- Encountered manufacturing issues with a failed reagent released to public health laboratories, which limited availability of testing outside the CDC (FDA:Coronavirus (COVID-19) Update - FDA Expedites Review of Diagnostic Tests to Combat COVID-19 [Accessed 24 April 2020])
- New York state department of public health developed its own molecular assay to satisfy unmet demands; granted second emergency use authorization on February 29, 2020 (FDA: Emergency Use Authorizations - In Vitro Diagnostics EUAs [Accessed 24 April 2020])
- Virus samples became available to private assay developers for validation in late February, 2020
- Rapidly growing list of commercial assays since mid March, 2020 (exceeding 25 as of April 10, 2020) (FDA: Emergency Use Authorizations - In Vitro Diagnostics EUAs [Accessed 24 April 2020])
Technology platforms
- Current commercial in vitro diagnostic assays typically feature:
- Qualitative rRT-PCR for amplification of viral RNA in respiratory samples
- Dual or triple amplification targets may include genetic sequences from nucleocapsid (N) gene, envelope (E) gene, spike (S) protein or ORF1ab
- First commercial molecular assay to receive emergency use authorization: Roche cobas (March 12, 2020)
- Rapid point of care assay by Abbott Diagnostics granted emergency use authorization on March 27, 2020 based on isothermal nucleic acid amplification
- Serology assay, typically either a rapid diagnostic test (lateral flow assay) or enzyme linked immunoassay (ELISA) to detect IgM and IgG antibody immune response in the blood
- May be helpful for retesting symptomatic / suspected patients who have tested negative by molecular method
- Can help to determine who has immunity and who may donate convalescent plasma in the proper clinical context (FDA: Coronavirus (COVID-19) Update - Serological Tests [Accessed 24 April 2020])
- May help to identify asymptomatic infection as a part of contact tracing or mitigation strategy
- Seroconversion of 50% at 13 days (median) and 100% at 19 days after symptom onset in 1 cohort of 285 patients (Nat Med 2020 Apr 29 [Epub ahead of print])
- Not for sole diagnosis of acute illness
- FDA review waived for serology assays as of March 16, 2020, upon assay validation, notification of the FDA and inclusion of a disclaimer (FDA: Coronavirus (COVID-19) Update - Serological Tests [Accessed 24 April 2020])
- First serology assay received emergency use authorization on April 1, 2020, by Cellex for testing serum, plasma or whole blood from venipuncture in the laboratory (FDA: Cellex - qSARS-CoV-2 IgG/IgM Rapid Test [Accessed 24 April 2020])
- Many are being developed or released in the U.S., some of which have been in use in other countries
- First next generation sequencing (NGS) assay under COVID-19 EUA (6/9/2020): Illumina COVIDSeq Test
- High throughput sequencing of amplified viral RNA
- Detects 98 targets on SARS-CoV2 genome
- 12 hours of processing time (up to 3072 samples on NovaSeq or 384 samples on NextSeq instruments)
- Nasopharyngeal, oropharyngeal and nasal swabs
FDA's list of serological assays that should not be distributed
- U.S. FDA recommends health care providers to "be aware that not all marketed serological tests have been evaluated by the FDA"
- 53 EUA serological assays have been removed from the FDA website notification list and should no longer be used for COVID-19 testing (FDA: What Tests Should No Longer Be Distributed for COVID-19? [Accessed 29 June 2020])
- An independent study conducted by a federally funded national laboratory has found that 15 of 20 commercial SARS-CoV-2 antibody assays should not be marketed (FDA: Independent Evaluations of COVID-19 Serological Tests [Accessed 29 June 2020])
- Study assays were each compared against 110 frozen serum samples with known IgM and IgG status (30 positive and 80 negative)
- Performance characteristics were evaluated, including sensitivity, specificity, positive predictive value and negative predictive value (assumed prevalence of 5%)
- EUA authorization was granted for 5 serological assays based on this study:
- Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG Antibody Test Kit
- Euroimmun SARS-COV-2 ELISA (IgG)
- Hangzhou Biotest Biotech, Co., Ltd. Covid-19 IgG/IgM Rapid Test Cassette
- Hangzhou Laihe Biotech Co., Ltd. Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
- Healgen COVID-19 IgG/IgM Rapid Test Cassette
- 15 serological test kit manufacturers received “should not be distributed” status or market withdrawal notice based on unacceptable assay performance:
- Abacus Pharma International; Accudiagnostics; Atlas-Link (Beijing); Aurora Biomed Inc.; Biomedomics; ChemBio; Chemtron Biotech, Inc.; GP Getein Biotech, Inc.; Phamatech; SD BIOSENSOR, Inc.; Shanghai Fosun Long March Medical Science Co., Ltd.; TESTSEALABS; Tianjin Beroni Biotechnology Co., Ltd.; W.H.P.M, Inc.; Zhongshan Bio-Tech Co LTD
ICD, CPT and Medicare rate
- The first ICD-10-CM diagnostic code listed below can be used for positive COVID-19 laboratory test results, while the last three below for negative or unknown test results:
- The following CPT billing codes and their corresponding Medicare reimbursement rates can be used for SARS-CoV-2 laboratory testing (CMS: Medicare Administrative Contractor (MAC) COVID-19 Test Pricing [Accessed 7 August 2020], ACOG: Coding for COVID-19 Testing [Accessed 7 August 2020]):
CPT code Medicare rate Description 86328 $45.23 Immunoassay for SARS-CoV-2 (COVID-19) antibody(ies), qualitative or semiquantitative, single step method (e.g. reagent strip used in the point-of-care setting) 86769 $42.13 Immunoassay for SARS-CoV-2 (COVID-19) antibody(ies); qualitative or semiquantitative; multiple step method 87635 $51.31 Infectious agent detection by nucleic acid (DNA or RNA); SARS-CoV-2 (COVID-19), amplified probe technique 87426 $45.23 Antigen detection by immunoassay, (e.g., enzyme immunoassay [EIA], enzyme linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple step method; SARS-CoV or SARS-CoV-2 U0001 $35.91 2019 novel coronavirus real time RT-PCR diagnostic test panel at a CDC lab U0002 $51.31 2019-nCoV coronavirus, SARS-CoV-2/2019-nCoV (COVID-19) using any technique, multiple types of subtypes at a non-CDC lab U0003 $100 Infectious agent detection by nucleic acid (DNA or RNA); SARS-CoV-2 (COVID-19), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R U0004 $100 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R 0223U $416.78 QIAstat-Dx Respiratory SARS-CoV-2 (proprietary laboratory analyses), infectious disease (bacterial or viral respiratory tract infection), pathogen specific nucleic acid (DNA or RNA), 22 targets including SARS-CoV-2, qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected 0202U $416.78 BioFire® respiratory panel 2.1 (RP2.1) (proprietary laboratory analyses; contractor priced until a national fee schedule can be established), infectious disease (bacterial or viral respiratory tract infection), pathogen specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected
Diagrams / tables
- Below is a partial list of commercially available SARS-CoV-2 assays in the U.S. and a comparison of the key features based on manufacturers’ claims gleaned from package inserts and news releases (FDA: Emergency Use Authorizations - In Vitro Diagnostics EUAs [Accessed 24 April 2020])
- Independent studies are needed to verify the comparative performances of these assays; due to the rapid rollout of these emergency use authorization assays, peer reviewed publications will take time to catch up
- The analytical sensitivities (limits of detection) vary widely among assays
Table 1. Performance Characteristics of Some EUA SARS-CoV-2 Assays
| Manufacturer | In Vitro Diagnostic EUAs | Technology | Claimed LoD | Sensitivity | Specificity |
| Abbott | Abbott RealTime SARS-CoV-2 Assay | rRT-PCR | 100 copies/mL | 100% at 1-2x LoD | 100% |
| Abbott | ID NOW COVID-19 Test | Isothermal nucleic acid amplification | 125 copies/mL | 100% at 2-5x LoD | 100% |
| Becton Dickonson | BD SARS-CoV-2 Reagents | rRT-PCR | 40 copies/mL | 95% at 1-2x LoD, 100% at 3-5x LoD | 100% |
| Becton Dickonson | BioGX SARS-CoV-2 Reagents | rRT-PCR | 40 copies/mL | 95% at 1-2x LoD, 100% at 3-5x LoD | 100% |
| BGI Genomics | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV | rRT-PCR | Throat: 150 copies/mL; BALF: 100 copies/mL | Throat: 95% at 1x LoD; BALF: 100% at 1x LoD | 100% |
| *Bio-Rad | Platelia SARS-CoV-2 Total Ab assay | ELISA (IgM, IgA, IgG) | 100% serum (n=27), 83% plasma (n=24) | 99.6% | |
| BioFire | BioFire COVID-19 Test | rRT-PCR | 330 copies/mL | 100% at 1x LoD | 100% |
| *Cellex | qSARS-CoV-2 IgG/IgM Rapid Test | Lateral flow immunoassay (IgM, IgG) | 94% (n=128, no symptoms to severe) | 95.6% | |
| Cepheid | Xpert Xpress SARS-CoV-2 | rRT-PCR | 250 copies/mL | 100% at 2x LoD | 100% |
| Co-Diagnostics | Logix Smart Coronavirus Disease 2019 (COVID-19) Kit | rRT-PCR | 4290 copies/mL of sputum | 100% at 1x LoD | 100% |
| DiaCarta | QuantiVirus SARS-CoV-2 Test Kit | rRT-PCR | ABI QuantStudio 5: 200 copies/mL; ABI 7500 Fast Dx: 100 copies/mL | ABI QuantStudio: 95% at 1x LoD; ABI 7500 Fast Dx: 100% at 1x LoD | 100% |
| DiaSorin | Simplexa COVID-19 Direct Assay | rRT-PCR | 500 copies/mL | 100% at 1x LoD | 100% |
| GenMark | ePlex SARS-CoV-2 Test | RT-PCR, electrochemical detection | 1 x 105 copies/mL | 94.4% at 1x LoD | 100% |
| Gnomegen | Gnomegen COVID-19 RT-Digital PCR Detection Kit | rRT-PCR, digital, nanofluidic chip | 60 copies/mL | 100% at 1-2x LoD | 100% |
| Hologic | Panther Fusion SARS-CoV-2 Assay | rRT-PCR | 0.01 TCID50/mL | 100% at 1-5x LoD | 100% |
| InBios | Smart Detect SARS-CoV-2 rRT-PCR Kit | rRT-PCR | 7500 Fast Dx: 1100 copies/mL; CFX96 Touch: 860 copies/mL | 100% at 1x LoD | 100% |
| Ipsum | COV-19 IDx Assay | rRT-PCR | 8.5 x 103 copies/mL | 100% at 1x LoD | 100% |
| Luminex | NxTAG CoV Extended Panel Assay | rRT-PCR | 5.0 x 103 copies/mL | 95% at 2x LoD | 100% |
| Luminex | ARIES SARS-CoV-2 Assay | rRT-PCR | 7.5 x 104 copies/mL | 100% at 1x LoD | 100% |
| Mesa Biotech | Accula SARS-CoV-2 | rRT-PCR, lateral flow | 200 copies/60uL reaction (pooled nasal & throat) | 100% at 2-50x LoD | 100% |
| NeuMoDx | NeuMoDx SARS-CoV-2 Assay | rRT-PCR | 150 copies/mL | 100% at 1.5x LoD | 100% |
| *Ortho | Vitros Anti-SARS-CoV-2 Total Reagent Pack and Total Calibrator | Immunometric luminescent reaction (IgG) | 92.3% at 1-5 days, 88.9% at 6-15 days, 75% at 16-22 days post-PCR | 100% | |
| PerkinElmer | PerkinElmer New Coronavirus Nucleic Acid Detection Kit | rRT-PCR | ORF1ab: 8.3 copies/mL; N: 27.2 copies/mL | ORF1ab: 100% at 1.5x LoD; N: 100% at 1.5x LoD | 100% |
| Primerdesign | Primerdesign Ltd COVID-19 genesig Real-Time PCR assay | rRT-PCR | 330 copies/mL | 94.7% at 1-2x LoD, 100% at 3-5x LoD | 100% |
| QIAGEN | QIAstat-Dx Respiratory SARS-CoV-2 Panel (22 bacterial & viruses) | rRT-PCR | 500 copies/mL | 100% at 1-2x LoD | 100% |
| Quidel | Lyra SARS-CoV-2 Assay | rRT-PCR | 800 copies/mL | 100% at 1x LoD | 100% |
| Roche | cobas SARS-CoV-2 Assay | rRT-PCR | 0.007 TCID50/mL | 100% at 1.5x LoD | 100% |
| *Roche | Elecsys Anti-SARS-CoV-2 | Sandwich immunoassay (antibodies) | 65.5% at ≤ 6 days, 88.1% at 7-13 days, 100% ≥ 14 days post-PCR | 99.8% | |
| Thermo Fisher | TaqPath COVID-19 Combo Kit | rRT-PCR | 10 copies/140uL | 100% at 1x LoD | 100% |
Abbreviations: LoD = limit of detection; rRT-PCR = real time reverse transcriptase polymerase chain reaction
Table 2. Categories of SARS-CoV-2 EUA Assays and Examples
| Category | In Vitro Diagnostic EUAs | Instruments | Throughput | Cycle Time |
| Point of Care Setting | ||||
| Abbott ID NOW COVID-19 Test | ID NOW | Nonbatch | 5 min (+), 13 min (-) | |
| Cepheid Xpert Xpress SARS-CoV-2 | GeneXpert Xpress System | Nonbatch modular | 45 min per cartridge | |
| Mesa Biotech Accula SARS-CoV-2 | Accula/Silaris Dock | Nonbatch cassette | 30 min | |
| Respiratory Pathogen Panel | ||||
| Qiagen QIAstat-Dx Respiratory SARS-CoV-2 Panel (22 bacterial & viruses) | QIAstat Dx Analyzer System | Nonbatch modular | About 1 hour per cartridge | |
| Serology | ||||
| Bio-Rad Platelia SARS-CoV-2 Total Ab | None | 96 wells per microplate (manual) | 1st incubation: 60 min 2nd incubation: 30 min | |
| Cellex qSARS-CoV-2 IgG/IgM Rapid Test | None | Nonbatch cassette | 15-20 min per cassette | |
| Ortho VITROS Immunodiagnostic Anti-SARS-CoV-2 Total Reagent and Calibrator | VITROS Eci/EDiQ/3600 or VITROS 5600/XT 7600 | Automated | 37 min incubation plus 48 min testing | |
| Roche Elecsys Anti-SARS-CoV-2 | cobas e411, e601, e602, e801 | Automated | 18 min | |
| Modular Cartridge / Cassette / Pouch | ||||
| BioFire COVID-19 Test | FilmArray 2.0 or Torch | Nonbatch modular | 50 min per pouch | |
| Cepheid Xpert Xpress SARS-CoV-2 | GeneXpert Dx / Infinity | Nonbatch modular | 45 min per cartridge | |
| GenMark ePlex SARS-CoV-2 Test | ePlex | Nonbatch modular | cartridge | |
| Luminex ARIES SARS-CoV-2 Assay | ARIES System | Nonbatch cassette | 2 hours per cassette | |
| Qiagen QIAstat-Dx Respiratory SARS-CoV-2 Panel (22 bacterial & viruses) | QIAstat Dx Analyzer System | Nonbatch modular | About 1 hour per cartridge | |
| High Throughput Capability | ||||
| Abbott RealTime SARS-CoV-2 Assay | m2000 RealTime | 96 wells per batch | ||
| BGI Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV | ABI 7500 Real Time PCR | 96 wells per batch | ||
| DiaCarta QuantiVirus SARS-CoV-2 Test Kit | ABI QuantStudio 5 / 7500 Fast Dx Real-Time PCR | Batch | ||
| DiaSorin Simplexa COVID-19 Direct Assay | LIAISON MDX | Batch | ||
| Hologic Panther Fusion SARS-CoV-2 Assay | Panther Fusion | 1150 samples per 24 hours | < 3 hours | |
| InBios Smart Detect SARS-CoV-2 rRT-PCR Kit | ABI 7500 Fast Dx Real-Time PCR / CFX96 Touch Real-Time PCR | 96 wells per batch | ||
| Luminex NxTAG CoV Extended Panel Assay | Luminex MAGPIX & bioMerieux easyMAG / EMAG | 96 wells per batch | < 2.5 hours thermal cycler run time | |
| NeuMoDx SARS-CoV-2 Assay | NeuMoDx 96 and 288 Molecular Systems | Random access, modular | ||
| Ortho VITROS Immunodiagnostic Anti-SARS-CoV-2 Total Reagent and Calibrator | VITROS Eci/EDiQ/3600 or VITROS 5600/XT 7600 | 100 wells per reagent pack | 37 min incubation plus 48 min testing | |
| PerkinElmer New Coronavirus Nucleic Acid Detection Kit | ABI 7500 Real-Time PCR | 96 wells per batch | ||
| Primerdesign Ltd COVID-19 genesig Real-Time PCR Assay | ABI 7500 / Bio-Rad CFX Connect / Roche LightCycler 4800 II | Batch | ||
| Quidel Lyra SARS-CoV-2 Assay | ABI 7500 Fast Dx/Standard, Roche LightCycler 480, Qiagen Rotor-Gene Q, BioRad CFX96 Touch, Thermofisher Quantstudio 7 Pro | Batch | ||
| Roche cobas SARS-CoV-2 Assay | cobas 6800/8800 | 384/960 per 8 hours | 3.5 hours | |
| Thermal Fisher TaqPath COVID-19 Combo Kit | Applied Biosystems 7500 Fast Dx | 96 wells per batch | 4 hours (incl. sample prep) | |
Board review style question #1
Which of the following is true regarding serology (nonmolecular) testing for SARS-CoV-2?
- Dual or triple genetic sequences are targeted to increase the performance of the assay
- It is typically based on reverse transcription followed by nucleic acid amplification
- Elevated IgA antibody to COVID-19 indicates suitability for convalescent plasma donation
- Suitable respiratory specimens include the nasopharyngeal swab and bronchial lavage
- The lack of an antibody response does not rule out acute infection
Board review style answer #1
E. The lack of an antibody response does not rule out acute infection
Comment Here
Reference: Diagnostic testing of SARS-CoV-2
Comment Here
Reference: Diagnostic testing of SARS-CoV-2
Board review style question #2
Which of the following groups of individuals is considered a top priority for COVID-19 testing according to the CDC?
- Children with earache
- Pre-employment screening for the retail industry
- Symptomatic healthcare workers and hospitalized patients
- Asymptomatic transportation personnel with contact exposure to a person with COVID-19
Board review style answer #2
C. Symptomatic healthcare workers and hospitalized patients are a top priority for COVID-19 testing
Comment Here
Reference: Diagnostic testing of SARS-CoV-2
Comment Here
Reference: Diagnostic testing of SARS-CoV-2
