Clinical Laboratory Evaluation Program

Test Approval

Laboratories who are seeking approval to offer tests on New York State specimens 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 and 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 website directly.

Submission Guidelines for Nucleic Acid Amplification Tests for Infectious Agents - Adopted 02/29/08

• Submission Guidelines (PDF -- 38k)
• 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)

Submission Guidelines for Trace Element Testing - Revised 10/27/06

• Submission Guidelines for Trace Element Testing - Alternate Matrices (PDF -- 41k)
• Submission Guidelines for Trace Element Testing - Alternate Matrices (WORD -- 98k)