CLIA LDT Validation Services

Innovative, efficient, and superior lab-developed tests (LDTs) are key for diagnostic laboratories to differentiate their portfolios. PanoHealth can help you expand your diagnostic menu with our LDT validation and assay development services. Our large R&D team has significant experience in rapidly developing and evaluating assays that are used for research and clinical use.

Assay Development

PanoHealth can rapidly develop an LDT-ready assay from scratch or help you validate a pre-established LDT at your high-complexity laboratory. Our comprehensive service is tailored to your laboratory needs.

LDT Process

  1. Validation Requirements: Our team will determine the test validation requirements and the best approach for you (e.g., platform, sample type, throughput, etc.).
  2. Development of Validation Protocol: The validation protocol is established according to CLSI regulatory guidelines, or a custom protocol can be determined in coordination with your medical director.
  3. Assay Development: Preliminary assay development will be performed at PanoHealth leveraging our qPCR, recombinant protein, antibody production, enzyme-linked immunosorbent assay (ELISA), lateral flow assay (LFA), and other immunoassay technologies.
  4. On-Site LDT Establishment: We will travel to your laboratory to provide on-site clinical validation testing according to regulatory requirements.
  5. Clinical Testing: With the LDT established, your CLIA laboratory can process clinical samples.

Our in-house LDT-ready menu contains diverse, pre-validated qPCR and immunoassay assays that can be run on a variety of commercially-available equipment and platforms.

Highlighting COVID-19 Specific LDT-ready Assays!
  • COVID-19 1-Step High Throughput PCR Assay: utilizes the RT-PCR method for the in vitro detection of SARS-CoV-2 nucleic acid in nasopharyngeal swab samples. The unique 1-Step Nucleic Acid Stabilization Buffer preps crude swabs for use directly in the PCR reaction, without laborious RNA extraction. The assay can detect as few as 4 copies/┬ÁL of SARS-CoV-2 virus. Only needing the green channel, this PCR kit can be used with a wide range of PCR instruments
  • COVID-19 Total Neutralizing Antibody (NAb) Assay: utilizes an ELISA-based method for the detection of total binding antibodies that correlate to neutralization to SARS-CoV-2 in human serum through the binding affinity of the SARS-CoV-2 Spike (S1 RBD) protein and the Angiotensin I Converting Enzyme 2 (ACE2) receptor complex

Please contact us to discuss your assay needs for your laboratory now!

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