At-home Test Kits for HbA1c and Urine Microalbum-Creatinine Ratio
- This RFQ was uploaded by the owner.
The Boston VA Research Institute, Inc. ("BVARI") is accepting quotes to provide 1,600 mail-ready in-home test kits for determination of hemoglobin A1c (HbA1c) and urine microalbum-creatinine ratio (i.e. requiring measurement of urine albumin and creatinine to calculate the ratio) for use in a single-site clinical trial. Patients will mail specimens to the lab for central processing. All testing will be performed over a 15 month period (tentatively: Sept 2013 - Dec 2014).
Each kit should include collection instructions, collection equipment (for a dry blood spot specimen and a urine specimen), and a mailing pouch (stamped and addressed for sending the specimen to a central lab). Shelf-lives of the HbA1c and urine test kits should be >1.5 years. Once obtained, the specimens should remain stable for at least 14 days during postal delivery with rugged handling of the package and with temperature tolerances between 20-100 degrees Farenheit. Assay for HbA1c must use a temperature and transport-stable methodology. Lab should hold certification from the National Glycohemoglobin Standardization Program. The HbA1c assay should have a coefficient of variation of 2%.
Specimens will be processed using coded identifiers. Each week, the lab will be required to transmit to the research team the specimens received (listed by coded identifier) and the test results. Reporting of results can occur via secure e-mail or secure website posting.
BVARI will code envelopes and/or vials and cover postage to send kits to the patients. Kits should be provided in a mail-ready envelope and should contain a stamped and addressed envelope for patients to send the specimen to the lab. BVARI will receive the entire shipment at once.
