SARS-CoV-2 Molecular Diagnostics Development

Authenticated materials for evaluating analytical sensitivity and specificity

Coronavirus Research Materials

Our growing collection includes genomic and synthetic RNA, heat-inactivated materials, polyclonal antibodies, and more!

Reliable diagnostic tools depend on credible reference materials

The highly pathogenic nature and transmission dynamics of SARS-CoV-2 has necessitated the availability of rapid, robust detection methods to ensure that infected individuals are treated in a timely manner. For commercial manufacturers developing SARS-CoV-2 molecular diagnostic tests for emergency use, the US Food & Drug Administration (FDA) has provided recommendations for validation studies to be conducted. To support this critical research, ATCC provides a variety of authenticated and clinically relevant materials for evaluating limit of detection, inclusivity, and cross-reactivity.

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Molecular Diagnostic Tools

We provide a variety of ready-to-use standards that can be used throughout the assay development process. Explore our collection of molecular standards and inactivated organisms for molecular diagnostics development.

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In Vitro Diagnostics

Health care providers rely on diagnostic tests to detect disease and monitor health. Discover why advanced biological models are essential for the development and validation of these essential tools.

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Design your SARS-CoV-2 assay

Our extensive collection contains a variety of species recommended by the FDA for SARS-CoV-2 molecular diagnostics development, including SARS-CoV-2 reference materials, high priority pathogens from the same genetic family as SARS-CoV-2, and high priority organisms likely present in respiratory specimens. To support your unique assay development needs, we provide these materials in a variety of formats.

  • Heat-inactivated preparations – Inviable, non-replicative preparations that are quantitated by Droplet Digital PCR or qPCR. These materials are ideal for use in molecular assays or as a process control (e.g., nucleic acid extraction through the qPCR amplification process).
  • Live strains – Minimally passaged, fully characterized strains that are authenticated using a polyphasic approach that confirms genotype and phenotype.
  • Genomic nucleic acids – Whole-genome preparations aseptically prepared from minimally passaged ATCC cultures. Each preparation is supported by stringent quality control testing to ensure product authenticity and functionality.
  • Synthetic nucleic acids – Quantitative DNA and RNA synthetically manufactured under ISO 13485 guidance to include key target regions from select viral, bacterial, and protozoan species. These standards enable researchers to work with higher concentrations of target nucleic acid sequences for unculturable or high-containment species.

Table 1. ATCC Resources representing FDA-recommended species for SARS-CoV-2 molecular diagnostic development 
Organism Heat-inactivated Strains Live Strains Genomic Nucleic Acids Synthetic Nucleic Acids
Human coronavirus 229E
Human coronavirus OC43
Human coronavirus HKU1
Human coronavirus NL63
Human metapneumovirus
Parainfluenza virus 1-4
Influenza A & B
Respiratory syncytial virus
Chlamydophila pneumoniae
Haemophilus influenzae
Legionella pneumophila
Mycobacterium tuberculosis
Streptococcus pneumoniae
Streptococcus pyogenes
Bordetella pertussis
Mycoplasma pneumoniae
Candida albicans
Pseudomonas aeruginosa
Staphylococcus epidermidis
Streptococcus salivarius ✓*

*A quantitative genomic format is not currently available for this product
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Evaluate assay performance

Because molecular diagnostic assays provide powerful tools for the rapid detection and identification of clinically relevant pathogens, it is essential that they are properly validated to guarantee accurate results and uncompromised data. To evaluate the performance of a novel molecular diagnostic test for SARS-CoV-2, the FDA recommends the species listed above for validation studies on the limit of detection, inclusivity, and cross-reactivity of the assay. These studies help ensure that the assay is able to accurately detect SARS-CoV-2 without reacting to related pathogens.

  • Limit of detection – The minimum amount of a target that can be accurately distinguished from the absence of a sample within a given level of confidence. For SARS-CoV-2 molecular diagnostic assays, the FDA recommends testing a quantitated inactivated viral preparation spiked into a clinical matrix as the inactivated preparation closely reflects the live virus in a clinical sample. Genomic RNA is also recommended as a material for testing.
  • Inclusivity testing – Confirmation that your assay detects the intended target. Testing should include multiple strains of SARS-CoV-2 and demonstrate that the strains can be detected by the proposed assay. In silico analysis of published SARS-CoV-2 sequences is also acceptable.
  • Cross-reactivity testing – Confirmation that your assay does not react with related pathogens or normal/pathogenic flora that may be present in the clinical sample. For this study, the FDA recommends testing high priority pathogens from the same genetic family and high priority organisms that are likely present in a respiratory specimen.

SARS-CoV-2 Molecular Diagnostics Development

Watch our webinar to discover how to remove culturing from the equation

Synthetic SARS-CoV-2 RNA are compatible with existing assays

ATCC has developed four quantitative synthetic molecular standards for use as controls in the development of assays designed to detect and quantify SARS-CoV-2. Because these standards are synthetically derived, they eliminate the need to culture viruses in the laboratory and they are safe to use under biosafety level 1 conditions. These constructs are compatible with several assays, including the nucleocapsid-targeted real-time RT-PCR primer and probe sets developed by the CDC.

SARS-CoV-2 Synthetic RNA

Table 2. ATCC synthetic SARS-CoV-2 RNA and compatible assays
ATCC No. Description Compatible assays
VR-3276SD Quantitative Synthetic SARS-CoV-2 RNA containing portions of ORF1ab, N, E, nsp12 (RdRp), and ORF1b-nsp14 genes

China CDC Primers and probes for detection 2019-nCoV (24 January 2020)

Diagnostic detection of Wuhan coronavirus 2019 by real-time RT-PCR – Charité, Berlin Germany (17 January 2020)

Detection of 2019 novel coronavirus (2019-nCoV) in suspected human cases by RT-PCR – Hong Kong University (23 January 2020) PCR and sequencing protocol for 2019-nCoV - Department of Medical Sciences, Ministry of Public Health, Thailand (Updated 28 January 2020)

US CDC Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus (28 January 2020)

US CDC panel primer and probes– U.S. CDC, USA (28 January 2020)

VR-3277SD Quantitative Synthetic SARS-CoV-2 RNA: containing a portion of Spike 5’ end gene.

Detection of WN-Human1 sequence from clinical specimen. – National Institute of Infectious Diseases Japan (17 January 2020)

VR-3278SD Quantitative Synthetic SARS-CoV-2 RNA: containing a portion of Spike 3’ end gene.

PCR and sequencing protocols for 2019-nCoV- National Institute of Infectious Diseases Japan (24 January 2020)

VR-3279SD Quantitative Synthetic SARS-CoV-2 RNA containing the portion of nsp9 and nsp12 (RdRp) genes

RT-PCR assays for the detection of SARS-CoV-2 with RdRp - Institut Pasteur, Paris (2 March 2020)

Diagnostic detection of Wuhan coronavirus 2019 by real-time RT-PCR – Charité, Berlin Germany (17 January 2020)