Clinical Laboratory Evaluation Program
Test Approval
Laboratories who are seeking approval to offer tests on New York State specimens, using assays which have not been cleared by the FDA, FDA approved tests that have been modified from their intended use, in-house developed assays, or assays labeled ASR, IUO or RUO, must submit materials as described in these Submission Guidelines.
These guidelines and accompanying forms represent current Program policy and procedure for granting the approval required pursuant to 10NYCRR Section 58-1.10(g).
The following files are are available as Adobe Portable Document Format (PDF) files. The Adobe Acrobat Reader software is required to view and print these forms. The software is free and can be downloaded from the Adobe web site directly.
Expedited approval of molecular assays for the detection of novel influenza A / H1N1 (swine-like) UPDATE (06/23/09)
Laboratories wanting to offer novel influenza A / H1N1 (swine-like) detection assays that have been developed and validated for use under public health emergencies can submit the assay for expedited approval using the following guidelines, criteria, and algorithm.
- NYSDOH Influenza Assay Validation Updated Guidelines (PDF file size: 30K)
- Amended Result and Reporting for Expedited H1N1 (PDF file size: 21K)
- Novel H1N1 Resulting Algorithm (PDF file size: 80K)
Submission Guidelines for Nucleic Acid Amplification Tests for Infectious Agents - Adopted 02/29/08
- Submission Guidelines - updated 07/01/09 (PDF -- 72K)
- Section I Notification (PDF -- 66K)
- Example of validation study for the detection of Neisseria meningitidis using real-time PCR in CSF and whole blood (PDF -- 136K)
- Example of validation study for the detection of Anaplasma phagocytophilum using real-time PCR in whole blood (PDF -- 99K)
Comments, Responses and Finalization Announcement
- Comments and Responses to Proposed Guidelines - 10/30/06 (PDF -- 74K)
- Finalization Announcement of Guidelines - 02/29/08 (PDF -- 10K)