Coronavirus (SARS-CoV-2): Test Kits to Detect the Causative Agent of COVID-19

SARS-CoV-2 Antibodies

*rapidmicrobiology.com does not supply any products we help connect buyers with appropriate manufacturers, the information on this page is intended for healthcare professional use only,

Key points: 

  • Within seven weeks of the first reported case of COVID-19, there had been 76,769 people infected with the virus and 2,249 deaths caused by the virus. 
  • Most qPCR assays have three targets; Orf1, E-gene and N-gene. 
  • Check what authorizations a kit has, many kits are Research Use Only (RUO)
  • But manufacturers can apply for emergency use authorization (EUA) from the US FDA for clinical diagnostic use.
  • In the EU, manufacturers can obtain CE marking for In Vitro Diagnostic use

Updated: 15th of May 2020

Introduction: SARS-CoV-2 (novel coronavirus) was first reported on 31st Dec 2019 in the city of Wuhan, China. Initial cases were linked to a seafood market in Wuhan, and within two weeks, China and international airports began screening passengers coming from the area with infrared thermometer devices.

Although efforts were made to contain its spread, incidences of infection were reported in neighbouring countries, i.e. Korea and Japan. In one notable case, where government health officials were criticized for mishandling the containment of the virus, and where the virus was allowed to be spread between people, was on the Diamond Princess cruise ship.

In this incident, passengers were told they could not leave the cruiser after it was found that one person who departed a week previously, had shown positive for the virus. The ship was then used to 'quarantine' the remaining passengers until they were all tested. However, this had an undesired effect, as more people on the ship showed positive for the virus, it was clear that this impromptu quarantine holding was acting more like an incubator for the virus and allowed its transmission between people on board. 

By the 30th of January, WHO had declared SARS-2-CoV, the virus that causes the disease Covid-19, a public health emergency of international concern.

The virus has been designated SARS-CoV-2 by the Coronavirus Study Group (CSG) of the International Committee on Taxonomy of Viruses. The CSG formally recognizes this virus as a sister to severe acute respiratory syndrome coronaviruses (SARS-CoVs) of the species Severe acute respiratory syndrome-related coronavirus and designates it as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Infection by the virus can cause respiratory symptoms, fever, and fatigue. But in severe cases, especially people with compromised immune systems, the virus can cause severe acute respiratory syndrome (SARS), organ failure and even death. 

Coronaviruses are enveloped viruses with a positive-sense, single-stranded RNA genome belonging to the Coronaviridae family. The virus belongs to the 2B group of the betacoronavirus family, which is the same family as SARS-CoV and MERS-CoV and has 70% similarity in genetic sequence to SARS. These viruses are given the name corona (Latin for crown) because they possess a crown-like coat ( club-shaped glycoprotein spikes protruding from it's surface). These spikes allow the viruses to bind to certain receptors on our cells. 

The structure of SARS-CoV-2; consists of a spike protein; which includes two regions, S1 and S2, where S1 is for host cell receptor binding and S2 is for membrane fusion. The spike protein is a typical target for neutralizing with antibodies and vaccines. It been reported that SARS-CoV-2 can infect the human respiratory epithelial cells 100-1000 times more than previous coronavirus strains and does so by interacting with human ACE2 receptors. 

The Nucleocapsid Protein is the most abundant protein in SARS-CoV-2. The N-protein is a highly immunogenic phosphoprotein and rarely changes. The N protein of SARS-CoV-2 is often used as a marker in diagnostic assays.

There is also the hemagglutinin-esterase dimer, a membrane glycoprotein, an envelope protein,  and RNA. 

COVID-19 Nucleic Acid Testing:  

The majority of molecular-based detection kits made available for SARS-CoV-2 are real-time reverse transcriptase PCR assays. In some of the kits that were released in the early days of the outbreak, mismatching with SARS-CoV was a problem. But as time went on and more countries became involved, more companies began developing highly specific test kits for SARS-CoV-2.  These kits were helped by the public database GISAID, which laboratories were using to share sequence information from positive SARS-CoV-2 samples to the science community.

Many of the kits contain three assays, each assay targeting a different gene in the virus, so if the virus does mutate the chances of all three targets mutating is low. However if one, or two, of these assays, is positive, then the result must be recorded as inconclusive. These targets are the Orf1 gene (human RNA polymerase protein), the N-gene (the nucleocapsid protein) and the E-gene (envelope protein). There are some kits which target the S-gene (spike protein) but these are limited. An increasing number of the products have received Emergency Use Authorisation (EUA) from the FDA and have received CE-marking for sale in Europe, with still some products only available for Research Use Only (RUO).

Swabs: Based on CDC guidelines for clinical specimensswabs with synthetic fibers and plastic shafts should be used for nasopharyngeal collections when 2019-nCoV is suspected. It's important not to use calcium alginate swabs or those with wooden shafts as they may contain materials that interfere with test results. For upper respiratory specimens, the CDC is recommending nasopharyngeal washes/aspirates, nasal aspirates or to collect both a nasopharyngeal swab AND an oropharyngeal swab made of synthetic fibre with plastic applicators. Once the specimens are collected, it is recommended that the swabs are placed in 2-3 ml of viral transport media. Suppliers of these swabs are listed in tables below. 

COVID-19 Immunoassays: 

Antibody tests: These tests are performed on blood samples from infected persons became a useful tool in elucidating the links between several cases. These links would not have been made if viral particles were looked for via PCR methods. This is due to the fact that the patient's immune defence might be successful in eliminating the virus and hence removing any trace of where it came from. However, when specific antibodies are searched for in the same patient, they will be able to be detected because they stay within the blood for several years. Commercial immunoassay tests to detect COVID-19 include a dual ELISA test to be performed. This detects specific IgA and IgG against the virus in the blood of infected patients. There is also an automated fluorescent immunoassay system to measure quantitatively or semi-quantitatively the concentration of the targeted analyte, which can be the viral antigen or IgM/IgG

Antigen tests: These tests are new to the market and rely on the detection of viral proteins in swab samples They consist of monoclonal antibodies specific for the viral antigens and results are seen by the naked eye by way of chromatographic particles. There have only been a few of these tests commercialized and normally require a high viral count to work effectively. There were reports in the media, that national health authorities who had purchased these tests, could not rely on the results due to its poor accuracy upon validating them.

 

COVID-19 Tests In development:

Near ‘patient care’ or near POC assays that test for SARS-CoV-2 are currently in development and are awaiting approval by regulatory agencies in the form of a EUA or CE-IVD certification. There has so far been one POC test given FDA-EUA. These kits need to be used on a small analyser the hospital laboratory would need to have. On average, results are returned within the hour after taking a sample from the patient.

There is also nanosensor diagnostics platforms in development to test for the virus, which would replace thermal screening guns, currently screening for high fever in people coming through airports and border controls. This technology, which will be in the form of a hand-held device, claims to give results specific for this virus and can produce a result within one minute. It does this by detecting the nucleocapsid protein specific for this virus by nanosensor and aptamer technology.

* NOTE - Antigen and antibody (IgG/IgM) detection kits should not be used as sole basis for diagnosis due to possible false positives and false negatives - check with the manufacturer for claimed specificity and sensitivity.

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Supplier Information

- Reagents for qPCR + Standards and Controls

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Helix Elite - SARS-CoV-2 IVD Control US Microbiologics, Inc. Website
SOLIScript® 1-step CoV Kit Solis BioDyne Website
SARS-CoV-2 Synthetic RNA Control 229E OC43 Microbiologics, Inc. Website
Magnetic Prep Kit VI (RNA Extract + Purification) BIOTECON Diagnostics Website
qPCRbio Probe 1-step-go Kit PCR BioSystems Website
SARS-CoV-2 Standard Bio-Rad Laboratories (Clinical Diagnostics) Website
RNA Extraction Products Thermo Fisher Website
CDC & WHO Genes, NL63, 229E, OC43 (not sold to US) Helvetica Health Website
AccuPlex COVID-19 Ref Materials SeraCare Life Sciences Website
Reference Materials, Standards and Cell Lines LGC Standards Website
RNA Extraction Kit Advanced Molecular Diagnostics Website
Quick-DNA/RNA™ Viral MagBead extraction kits Zymo Research Website
Twist Synthetic SARS-CoV-2 RNA Control 1 & 2 (FDA) Twist BioScience Website
229E, NL63,OC43, SARS-CoV-2 Recombinant Control & Viral Culture Fluid ZeptoMetrix Corporation Website
Custom Lentivirus Pseudotyped AMSBIO Website
VIRSeek RNA Extractor 96 tests Eurofins Gene Scan Technologies Website
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- Ready-to-Use qPCR Kits

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1copy™ COVID-19 qPCR Kit (CE-IVD) (US FDA-EUA) 1drop Website
ANDiS® SARS-CoV-2 RT-qPCR (FDA-EUA, CE-IVD) 3DMed Website
2019-nCov nucleic acid (Fluorescence PCR) (CE-IVD) Anlong Gene Website
ARS-CoV-2 Real Time PCR LAB-KIT™ (CE-IVD) Biomaxima Website
RT-PCR Kit For COVID-19 Coronavirus (CE-IVD) Biotec Biomedical Website
Colorimetric and Isothermal Detection COVID-19 (CE-IVD) Biotec Biomedical Website
Logix Smart™ 2019-nCoV qPCR test (CE-IVD) (US FDA-EUA) Co-Diagnostics Website
GeneFinderTM COVID-19 Plus RealAmp Kit (CE-IVD) ELITech Group Website
Roche cobas SARS-CoV-2 Test (CE-IVD, FDA-EUA, WHO-EUA) Roche Diagnostics Website
genesig 2019-nCoV (CE-IVD, WHO-EUA, USA FDA-EUA)) Primerdesign Website
Sansure Biotec 2019-nCoV (China FDA–EUA; CE-IVD) Sansure Biotech Website
2019-Novel Coronavirus Triplex RT-qPCR Kit (CE-IVD) Vazyme Medical Website
Kewei COVID-19 Kit (CE-IVD; RUO) Kewei Diagnostics Website
Std M nCoV Real Time Kit (US FDA-EUA, Korea MFDS–EUA; CE-IVD) SD Biosensor Website
Q-Sens® 2019-nCoV Kit (CE-IVD) CancerRop Website
Real Time Multiplex RT-PCR (China NMPA FDA–EUA; CE-IVD) LifeRiver Website
GenePro COVID-19 Detection Test (CE-IVD) + v2 Gencurix Website
COVID-19 CE IVD qPCR assay AssayGenie Website
ORF1ab Gene Triple Fluor. PCR (China FDA–EUA; CE-IVD) Beijing Applied Biological Website
BIOFIRE® COVID-19 test (USA FDA-EUA) BioFire Defense Website
Real Time Multiplex PCR (China FDA–EUA; CE-IVD) Daan Diagnostics Website
COVID-19 RT PCR Kit (CE-IVD; manual; automated) Chaozhou Hybribio Website
Novel Coronavirus Real Time PCR Kit (CE-IVD) Getein Biotech Website
PowerChek™ Real Time PCR (Korea MFDS–EUA; CE-IVD) Kogene Website
RealStar 2019-nCoV Real Time PCR Kit (US FDA-EUA) altona diagnostics Website
REALQUALITY RQ-2019-nCoV (CE-IVD) AB Analitica Website
WizDx™ Covid-19 Crytsal Mix PCR Kit WizbioSolutions Website
2019 New Coronavirus (2019-nCoV) Test Kit Anitoa Website
Fluorescent RT-PCR Kit, Target:ORf1ab (FDA-EUA) BGI Genomics Website
PerkinElmer® Coronavirus NAT (CE-IVD, USA FDA-EUA) PerkinElmer Website
SARS-COV-2 R-GENE® & BIOFIRE® FILMARRAY® bioMérieux Website
ExAmplar COVID-19 RT PCR kit Boditech Inc Website
Aridia COVID-19 Real-Time PCR test (CE-IVD) CTK Biotech Website
quanty-CONV-19 (CE-IVD) Clonit Website
VIASURE® Real-Time PCR Detection Kits (CE-IVD) Certest Biotec SL Website
GPS™ 2019-nCoV qPCR kit Genetic PCR Solutions Website
ePlex SARS-CoV-2 Test (USA FDA-EUA) GenMark Diagnostics Website
CLART®COVID-19 & qCOVID-19 Genomica Website
US CDC 2019-nCoV qRT-PCR Detection Assay Genscript Website
PerfectLyo SARS-COV-2 Real Time PCR kit Jiangsu Bioperfectus Tech. Website
RADI COVID-19/COVID-19 Triple Detection (CE-IVD) KH Medical Website
COVID-19 CE-IVD qPCR kit Meslo Website
2019-nCoV Real-Time RT-PCR Kit MoBiTec Website
2019-nCoV TaqMan RT-PCR Kit (Catalog# TM67100) Norgen Biotech Website
IDA®GENE SARS-CoV-2 R-Biopharm AG Website
Allplex™ 2019-nCoV Assay (US FDA-EUA) Seegene Website
STAT-NAT® Covid-19 HK and STAT-NAT® Covid-19 B Sentinel CH Website
LAMP-COVID-19 SunStar Joint Stock Company Website
TaqMan™SARS-CoV-2 Assay Kit v2 (EUA-FDA) Thermo Fisher Website
ViroKey™ SA201 SARS-CoV-2 RT-PCR Test Vela Diagnostics Website
VereCoV™ Detection Kit Veredus Laboratories Website
2019-nCoV Fluorescent PCR Wuxi Diagnostics Website
Corona Virus 2019 Nucleic Acid Detection (CE-IVD) Wuhan HealthCare Biotechnology Website
SARS-CoV-2 nucleic acid test (CE-IVD) Wuhan EasyDiagnosis Website
Zena Max-SARS-CoV-2 RT-PCR detection (CE-IVD) Advanced Molecular Diagnostics Website
COV-19 IDx assay, Target: N1 & RdrP (FDA-EUA) Ipsum Diagnostics Website
QIAstat-Dx Respiratory SARS-CoV-2 Panel, Target: RdRP & E gene (FDA-EUA) Qiagen Website
NeuMoDx SARS-CoV-2 Assay, Target: Nsp2 gene and N-gene (FDA-EUA) NeuMoDx Website
NxTAG CoV Extended Panel, Target: ORF1ab, N, E (USA FDA-EUA) Luminex Corp. Website
ARIES® SARS-CoV-2 Assay (US FDA-EUA) Luminex Corp. Website
Acu-Corona™ 2.0/3.0 Kits BIOTECON Diagnostics Website
VISION COVID19 EASYPREP REAL TIME PCR Ageback, Laboratory Systems Website
BioGX SARS-CoV-2 Reagent kit (FDA-EUA) BioGX Website
SARS-CoV-2 qPCR Test (8 Kits in Total Available Targeting all Genes) (RUO) YouSeq Website
TaqPath™ COVID-19 Combo Kit Thermo Fisher Website
Panther Fusion® SARS-CoV-2 Assay (USA FDA-EUA)) Hologic Website
Lyra SARS-CoV-2 Assay (USA FDA-EUA) Quidel Website
Quest SARS-CoV-2 rRT-PCR (USA FDA-EUA) Quest Diagnostics Website
Simplexa COVID-19 Direct (USA FDA-EUA) DiaSorin Molecular Diagnostics Website
Accula™ SARS-Cov-2 Test (USA FDA-EUA) Mesa Biotech Website
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (US FDA-EUA) ScienCell Laboratories Website
Gnomegen COVID-19 RT-Digital PCR Kit (US FDA-EUA) Gnomegendx Website
Smart Detect SARS-CoV-2 rRT-PCR Kit (US FDA-EUA) In Bios International Website
BD SARS-CoV-2Reagents for BD MAX (US FDA-EUA) BD Diagnostic Systems Website
QuantiVirusTMSARS-CoV-2 Test (US FDA-EUA) DiaCarta Website
iAMP COVID-19 Detection Kit (US FDA-EUA) Atila BioSystems Website
GS™ COVID-19 RT-PCR KIT (US FDA-EUA) GenoSensor Website
GeneFinder COVID-19 Plus RealAmp Kit (US FDA-EUA) OSANG Healthcare Website
PhoenixDx 2019-CoV (US FDA-EUA) Procomcure Biotech Website
GeneOne COVID-19 Nucleic Acid Diagnostic Kit (CE-IVD) Yeastern Biotech (GeneOne) Website
US CDC COVID-19 RT-PCR Test International Reagent Resource Website
U-TOPTM COVID-19 Detection Kit (Korea (US FDA, MFDS EUA - CE-IVD Seasun Biomaterials Website
Rheonix COVID-19 MDx Assay (US-FDA) Rheonix Website
LabGun COVID-19 RT-PCR Kit (US-FDA) Lab Genomics Website
FTD SARS-CoV-2 (US FDA-EUA) Fast Track Diagnostics Website
SARS-COV-2 R-GENE (US FDA-EUA) BioMerieux Website
Sherlock CRISPR SARS-CoV-2 Kit (US FDA-EUA) Sherlock BioSciences Website
OPTI SARS-CoV-2 RT PCR Test (US FDA-EUA) OPTIMedical Website
GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR Eurofins Technologies Website
Quick SARS-CoV-2rRT-PCR Kit (US FDA EUA) Zymo Research Website
Alinity m SARS-CoV-2 assay Abbott Website
Linea COVID-19 Assay Kit (US FDA-EUA) Applied DNA Website
TRUPCR® SARS-CoV-2 RT qPCR KIT (India CDSCO) 3B BlackBio Biotech Website
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- Immunoassays - Antibody Detection *Read Note

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Anti-SARS-CoV-2 Rapid Test (FDA-EUA) Hardy Diagnostics Website
Anti-SARS-CoV-2 ELISA IgA and IgG (CE-IVD) Euroimmun Website
Bio-Sheild ELISA COVID-19 Test Kits x 3 IgG, IgM and Total ProGnosis Biotech Website
COV1D-19 IgG/IgM Lateral Flow (CE-IVD) Era Biology Website
ACE II Activity Assay Kit COVID-19 (CE-IVD) AssayGenie Website
AFIAS Covid-19 Lat Flow (auto) & Ichromia Covid-19 Boditech Med, Website
OnSite COVID-19 IgG/IgM Rapid Test CTK Biotech Website
Virusee Covid-19 IgM/IgG Lateral-Flow assay Era Biology Website
Covid-19 IgG/IgM GICA Lateral Flow (CE-IVD) Shenzen Bioeasy Website
2019-nCoV ELISA IgM and IgM/IgG Wuxi Diagnostics Website
VivaDiag COVID-19 IgM/IgG Rapid Test (CE-IVD) VivaChek Website
SARS CoV-2 Rapid Test PharmACT Website
SARS-CoV-2 Antigen Detection ELISA Kit Sino Biological Website
ELISA: Anti-SARS-CoV-2 antibodies & NP antigen (RUO) Creative Diag. Website
COVID-19 Colloidal Gold (CE-IVD, China-FDA) Edinburgh Genetics Website
DPP COVID-19 Igm/IgG Test (US FDA-EUA) Chembio Diag. Website
IgM-IgG Combined Antibody Test BioMedomics Website
VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack Ortho Clinical Diagnostics Website
Roche Elecsys Anti-SARS-CoV-2 serology test (FDA-EUA) Roche Diagnostics Website
CareStart COVID-19 IgG/IgM Test AccessBio Website
GSD’s COVID-19 serology Tests Gold Standard Diagnostics Website
Platelia SARS-CoV-2 Total Ab assay (US-FDA) Bio-Rad Laboratories (Clinical Diagnostics) Website
SARS-CoV-2 (2019-nCoV) Antibody Titer Assay Kit (RUO) Sino Biological Website
AlphaBiolabs IgM-IgG Combined Antibody Rapid Test (CE-IVD) AlphaBioLabs Website
Anti-SARS-CoV-2 Rapid Test (FDA-EUA) Autobio Diagnostics Website
SARS-CoV-2 IgG assay (US-FDA) Abbott Laboratories Website
LIAISON SARS-CoV-2 S1/S2 IgG (US-FDA) DiaSorin Website
Twin Track Coronavirus Test LetsGetChecked Website
Eurofins ELISA Assays (IgA, IgG and IgM) Eurofins Technologies Website
Ansh Labs SARS-CoV2 IgG and IgM ELISA Ansh Labs Website
cPass Neutralizing Antibody Test GenScript Website
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- China NMPA Approved PCR Kits for Export

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COVID-19 Hybrid Capture Fluorescence Immunoassay Test Anbio Website
ORF1ab Gene Triple Fluor. PCR (China FDA–EUA; CE-IVD) Beijing Applied Website
2019-nCoV NA detection cPAS, combinatorial probe-anchor synthesis sequencing) BGI Genomics Website
2019-nCoV NA (Fluorescent PCR) BGI Genomics Website
2019-nCov PCR Kit (fluorescent PCR method) BioGerm Website
Respiratory Virus NA (isothermal amplification chip method) Capitol Biotech Website
Real Time Multiplex PCR (China FDA–EUA; CE-IVD) Daan Diagnostics Website
2019-Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit Fosun Pharma Website
2019-nCoV NA Detection (Fluores. PCR) (China FDA–EUA) GeneoDx Website
Real Time Multiplex RT-PCR (China NMPA,FDA–EUA,CE-IVD) LifeRiver Website
Novel Coronavirus 2019-nCov PCR Kit (fluorescent PCR method) Maccura Biotech Website
Sansure Biotec 2019-nCoV (China FDA–EUA; CE-IVD) Sansure Biotech Website
Nucleic Acid Reagent Test Kits for for the Novel Coronavirus (2019-nCoV) (Fluorescent Isothermal Amplification) Ustar Biotechnologies Website
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Test Kit (colloidal gold method) Vazyme Medical Website
SARS-CoV-2 nucleic acid test (CE-IVD) Wuhan EasyDiagnosis Website
2019-nCoV Nucleic acid Test Dual amplification) Wuhan Zhongzhi Biotechnology Website
2019-nCoV Nucleic acid Test(RNA isothermal amplification lateral flow assay Wuhan Zhongzhi Biotechnology Website
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- China NMPA Approved Antibody Detection Kits for Export *Read Note

- Automated Workstations for qPCR

- Next-Generation Sequencing (NGS) COVID-19 Kits

- Near-Patient/Point-of-Care qPCR

- Swabs

- Immunoassays - Antigen Detection *Read Note

- Components for COVID-19 Kit Manufacture

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Antigens and Antibodies for SARS-CoV-2 Immunoassays Sino Biological Website
SOLIScript® 1-step CoV Kit Solis BioDyne Website
LGC SARS-CoV-2 Probes and Primer Kit (FDA-EUA) Biosearch Technologies Website
AccuPlex™ COVID-19 reference materials SeraCare Life Website
Proteins, Antibodies, ACE2 Plasmids, RNAi, CRISPR AMSBIO Website
Outsource Manufacturing for SARS-CoV-2 Abingdon Health Website
Lateral Flow Components for SARS-CoV-2 ahlstrom-munksjo Website
Hi-Flow™ Plus Membranes for lateral flow Merck Millipore Website
SARS-CoV-2 spike, nucleocapsid antigens Creative Diagnostics Website
Reference Material, Standards and Cell Lines LGC Standards Website
SARS-COV-2 Proteins & IgM/IgG +Colloidal Gold Sheets For Immunoassay Kit Dev Real-Gene Labs Website
SARS-CoV-2 Spike, Nucleocapsid Antigens, Uncut sheets for Immunoassays Production AIVD Biotech Inc. Website
Custom Lentivirus Pseudotyped AMSBIO Website
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- COVID-19 Proficiency Testing

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COVID-19 EQA PROGRAM Oneworld Accuracy Website
SARS-CoV-2 molecular PT LGC Standards Website
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- Environmental Testing for SARS-CoV-2 on surfaces, waste water, air etc.

- Veterinary Diagnostics for COVID-19

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IDEXX SARS-CoV-2 (COVID-19) RealPCR™ Test for pets IDEXX Website
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- Home Testing for COVID-19

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testing rapidmicro Website
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