The following is a general description of typical contractual details, subject to discussion and alteration as needed.

General Information

Confidentiality (Non-disclosure) agreements signed as needed.

Preliminary discussion with contractor regarding the performance characteristics of the assay(s) to be used. Discussion to include details of:

1. Standard curve range
2. Declared threshold of analytical sensitivity
3. Sample type/volume required for assay
4. Declared cross-reactivity of the assay with significant molecules
5. Any known sample stability issues/storage recommendations

Testing

• All testing performed in duplicate unless otherwise specified.
• All testing performed on batches of samples (batch size to be agreed on prior to testing)

Samples

• Types of samples and approximate volume/sample to be agreed on prior to testing
• Samples to be submitted with simple identifiers (sample numbers).  No patient names or proprietary information required.
• Samples to be tested/reported within 5 working days of date received.
• Typically, any samples that read high off the standard curve will be pre-diluted and retested if the assay has proven linearity of sample dilution.
• Samples lower than the threshold of analytical sensitivity for the assay will be reported “<(level of anal. sens.)

Reporting

• Samples to be reported in two formats unless otherwise specified:
  1. Excel spreadsheet listing sample numbers and showing Mean value of the duplicate assay results (password protected).  Options open to discussion.
  2. FAX of raw data printout from our instrument with all Standards, controls, samples clearly identified, to include nominal values of all standards and ranges of all controls.
• Contractor invited to call us and participate in review of all FAXed data.

Payment

Payment is due for each batch of samples reported, at the time each batch of samples is reported/reviewed.   Typically we require that the contractor provide a PO number or credit card information that can cover the complete cost of all samples to be tested.  This needs to be in place before any samples will be tested.

We warrant that our lab tests are accurate and reproducible.  No warranty is made that the test results will support the null hypothesis of a research study.