Clinical specimens are used in three applications:
- Ongoing improvement/monitoring after an assay is launched
Usually the Validation step is the most demanding because regulatory agencies often require hundreds of samples be tested from multiple races, geographic areas, ages, gender, anticoagulants and sometimes even certain medical conditions or medications. In addition, they often specify which instrument can be used as the predicate. This requirement makes the acquisition of such a vast assortment of samples very challenging and time-consuming.
Cantor BioConnect helps assay manufactures obtain rare clinical specimens by facilitating complex collections worldwide. Remnants from clinical labs are the first choice (1-2ml), but if this isn’t possible, a prospective collection will be arranged (more costly and time-consuming but greater flexibility for volume, matrix, anticoagulant, instrument and demographics). Cantor BioConnect utilizes a variety of testing labs and hospitals to obtain almost any type of specimen including plasma/serum, urine, nasal swabs, sputum, and stool.
Matched sets (multiple anticoagulants from the same donor) are often available.
All sources are carefully reviewed before approval in order to ensure a high level of sample integrity and confirm that strict cold-chain requirements are adhered to. All specimens are collected under an approved IRB protocol and/or informed consent.
In order to validate the sensitivity of an assay, manufacturers use a series of serum samples collected from the same donor over a short period of time (usually a few weeks or months) following the development of a disease. The first few samples are positive, then the disease becomes increasingly positive. These seroconversion panels are normally obtained from a chronological series of regular blood donations (and so the most common analytes are HIV, Hepatitis, Zika, West Nile Virus, Chagas, and sometimes TORCH and Measles/Mumps). As soon as a donor becomes positive, the preceeding few donations and the proceeding few donations are sequestered and aliquoted for the panel. Each panel normally contains 1ml of each donation (typically 3-10 donations).
Cantor BioConnect offers fresh leukopaks, adipose tissue and bone marrow for stem cell/regenerative medicine work. Other human tissues are also available, such as skin, muscle, etc. All tissue is collected under approved IRB protocols.