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Respiratory Diagnostics

Authenticated materials for evaluating analytical sensitivity and specificity

Reliable diagnostic tools depend on credible reference materials

Rapid and robust detection methods are essential for containing the spread of dangerous respiratory pathogens and ensuring that infected individuals are treated in a timely manner. For molecular diagnostics manufacturers developing assays for 510(k) premarket submission to the US Food & Drug Administration (FDA), robust testing must be performed to demonstrate that the device is safe and effective as well as substantially equivalent to legally marketed devices. To support these validation studies, ATCC provides an extensive array of authenticated and clinically relevant materials for evaluating limit of detection, inclusivity, and cross-reactivity.

Design your respiratory diagnostic assay

Our extensive collection contains a variety of viral, bacterial, and fungal species for respiratory molecular diagnostics development, including 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.
  • High-titer viruses – Purified preparations provided at an infectious titer of >107 TCID50/mL, CEID50/mL, or PFU/mL.
  • 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.
  • Respiratory inclusivity and exclusivity panels  – ATCC’s respiratory inclusivity and exclusivity panels are composed of authenticated nucleic acids or heat-inactivated material derived from respiratory pathogens commonly cited for use as control materials in SARS-CoV-2 EUA submissions and/or FDA 510(k) submissions.

 

Explore our resources for respiratory molecular diagnostics development by product type

Panels  Viruses  Bacteria  Fungi

Respiratory Inclusivity Panel

MP-36

Price: $3,552.00 ea

Respiratory Exclusivity Panel

MP-37

Price: $3,396.80 ea

Table 1. Viruses

Organism Heat-inactivated Strains Live Strains Genomic Nucleic Acids Synthetic Nucleic Acids
Adenovirus 1       
Adenovirus 4       
Adenovirus 7         
Bocavirus         
Cytomegalovirus (HHV-5)         
Enterovirus A (EV-A71)         
Enterovirus B (Echovirus 6)         
Enterovirus C (Coxsackievirus A17)         
Enterovirus D (68)     
Epstein-Barr virus (HHV-4)        
Human coronavirus 229E         
Human coronavirus HKU1         
Human coronavirus NL63       
Human coronavirus OC43     
Human herpesvirus 1       
Human herpesvirus 2       
Human metapneumovirus
Influenza A virus subtype H1       
Influenza A virus subtype H3         
Influenza B virus       
Measles virus         
MERS-CoV       
Mumps virus     
Parainfluenza virus 1     
Parainfluenza virus 2        
Parainfluenza virus 3    
Parainfluenza virus 4    
Respiratory syncytial virus
Rhinovirus
SARS-CoV       
SARS-CoV-2         

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Table 2. Bacteria

Organism Heat-inactivated Strains Live Strains Genomic Nucleic Acids Synthetic Nucleic Acids
Acinetobacter calcoaceticus
     
Bordetella avium      
Bordetella bronchiseptica    
Bordetella hinzii      
Bordetella holmesii    
Bordetella parapertussis    
Bordetella pertussis
Chlamydophila pneumoniae
Chlamydia trachomatis  
Corynebacterium diphtheriae     
Escherichia coli    
Fluoribacter bozemanae      
Fluoribacter dumoffii (Currently Legionella dumoffii)      
Haemophilus influenzae
Klebsiella aerogenes    
Klebsiella oxytoca    
Klebsiella pneumoniae    
Lactobacillus acidophilus    
Lactobacillus plantarum    
Legionella feeleii      
Legionella longbeachae    
Legionella pneumophila
Moraxella catarrhalis    
Mycobacterium tuberculosis
Mycoplasma genitalium  
Mycoplasma hominis     
Mycoplasma orale    
Mycoplasma pneumoniae
Neisseria elongata      
Neisseria gonorrhoeae    
Neisseria meningitidis    
Proteus mirabilis    
Pseudomonas aeruginosa
Staphylococcus aureus    
Staphylococcus epidermidis       
Serratia marcescens     
Stenotrophomonas maltophilia    
Streptococcus agalactiae    
Streptococcus pneumoniae
Streptococcus pyogenes
Staphylococcus epidermidis
Streptococcus salivarius ✓*
Tatlockia micdadei    
Ureaplasma urealyticum    

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Table 3. Fungi

Organism Heat-inactivated Strains Live Strains Genomic Nucleic Acids Synthetic Nucleic Acids
Aspergillus flavus     
Aspergillus fumigatus
   
Candida albicans
Cryptococcus neoformans
   
Pneumocystis jirovecii
     
*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 respiratory molecular diagnostic test, we provide NGS standards to help optimize your workflow as well as a variety of materials 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 your target without reacting to related pathogens.

 

ATCC products for respiratory diagnostics development

3D illustration of covid-19 virus in red

SARS-CoV-2 Molecular Diagnostics Development

The highly pathogenic nature and transmission dynamics of SARS-CoV-2 have necessitated the availability of rapid, robust detection methods to ensure that infected individuals are treated in a timely manner. For SARS-CoV-2 molecular diagnostics manufacturers moving from emergency use authorization (EUA) to 510(k) premarket submission to the US Food & Drug Administration (FDA), robust testing must be performed to demonstrate that the device is safe and effective as well as substantially equivalent to legally marketed devices. To support these validation studies, ATCC provides an extensive array of authenticated and clinically relevant materials for evaluating limit of detection, inclusivity, and cross-reactivity.

Develop your SARS-CoV-2 assay

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