Molecular-based assays are powerful tools for the detection and identification of clinically relevant microbial pathogens. These technologies provide several advantages over traditional culture-based approaches, including rapid turnaround time, the potential for multiplexing, increased analytical sensitivity and specificity, and the ability to detect difficult-to-grow organisms. While molecular-based assays exhibit numerous benefits, they must be properly validated to guarantee accurate results and uncompromised data.
To meet this need, ATCC has made it a priority to provide a variety of ready-to-use, fully authenticated standards that can be used throughout the assay development process.
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Genomic nucleic acids – Quantitative 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.
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Synthetic nucleic acids – Quantitative DNA and RNA synthetically manufactured under ISO 13485 guidance to include key target regions from select bacterial, protozoan, and viral species. These standards enable researchers to work with higher concentrations of target nucleic acid sequences for unculturable or high-containment species.
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Certified reference materials – Genomic DNA produced under an ISO 17034–accredited process to confirm identity, well-defined characteristics, and an established chain of custody. These materials are ideal for establishing sensitivity, linearity, and specificity during assay validation or implementation; challenging assay performance; and for benchmarking critical assay performance for regulatory submissions.
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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).
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NGS standards – Mock microbial communities available in a variety of formats and levels of complexity to challenge your assay standardization process.
See our products for assay development
ATCC is offering a 20% discount on microbial molecular standardsUse promo code ATCC-000069 at checkout to take advantage of this special discount. This limited-time offer is effective through July 31, 2026, so place your order before time runs out! *This offer is effective until July 31, 2026. The 20% discount applies only to the microbial molecular standards product numbers ending in DQ or SD; all other items are excluded from this promotion. For non-profit customers, the promotional discount is applied to the customer-specific pricing. The promo code must be applied at the time of checkout. The promo code must be applied in the “Promotional code” field in the shopping cart. For orders not placed through the website, the promo code must be included with the order at time of submission. U.S. customers only who receive direct shipments from ATCC. Void where prohibited. Restrictions may apply. |
Explore assay development resources for current outbreaks
SARS-CoV-2 molecular diagnostics development
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 strains and genomic and synthetic nucleic acids for evaluating limit of detection, inclusivity, and cross-reactivity.
Develop your SARS-CoV-2 AssayCyclospora cayetanensis molecular diagnostics development
Accurate detection of Cyclospora cayetanensis is critical for supporting food safety testing and outbreak investigations. To help diagnostic developers respond to emerging testing needs, ATCC offers a research use only (RUO) Quantitative Synthetic Cyclospora cayetanensis DNA (ATCC® PRA-3000SD™) designed to support assay development, validation, limit of detection studies, and inclusivity/exclusivity testing.
Develop your assay
