Nucleic Acid Testing (NAT) Managed Service

The Scottish National Blood Transfusion Service, Northern Ireland Blood Transfusion Service and the Welsh Blood Service each require a fully integrated microbiology managed service system for NAT (Nucleic Acid Testing). This includes equipment, maintenance, consumables, spare parts, upgrades, training, clinical education material, remote diagnostics, reporting and supports all to deliver a final result to the Authority’s information management system. Mandatory assays include the ability to detect HCV RNA, HBV DNA, HIV RNA, HEV RNA, B19V DNA and HAV RNA in plasma/serum samples from blood donors and HCV RNA, HIV RNA, HBV DNA, HEV RNA, B19V DNA and HAV RNA in plasma/ serum samples from tissue and stem cell donors.

The Authorities currently have the ability to detect Hepatitis C (HCV) ribonucleic acid (RNA), Human Immunodeficiency virus (HIV) RNA and Hepatitis B (HBV) deoxyribonucleic acid (DNA) in donations from blood, tissue and stem cell donors.

Tissue and stem cell donations may only be tested as individual donations for HCV RNA, HBV DNA, HIV RNA. SNBTS test various tissue and stem cell blood samples as singletons but do not carry out any testing on non-heart beating donations. An approximate indication of volumes for this testing is 1500 samples per annum.

The Authorities currently have the ability to detect Hepatitis E (HEV)) in donations from blood, tissue and stem cell donors. The successful Bidders system must be capable of detecting HEV RNA. (95% of donations will be tested in pools, 5% as ID NAT).

SNBTS currently have the ability to detect B19 DNA and HAV RNA in donations from blood, tissue and stem cell donors. If screening is performed in minipools, B19 testing must ensure that B19 DNA can be detected at a level that will ensure less than 104 IU/mL of B19V DNA in homogenous plasma pools.

WNV Testing is currently performed as a discretionary test by SNBTS and WBS and will possibly be introduced during the lifespan of the contract by NIBTS.

The routine screening period for WNV RNA commences each year on 1st May and ends 31st December however there is still a requirement to undertake a limited amount of screening in the intervening period. The requirements for WNV RNA testing are reviewed annually.

The Authorities uses a combination of Serum, EDTA plasma and EDTA gel collection tubes for all microbiological screening and the successful Bidders system must therefore be validated for both sample types.