([section]) HBV surface antigen and core antibody, anti-HCV antibody, HCV NAT
, and anti-HIV antibody testing are required for all donors; combined HIV antigen/ antibody or HIV NAT are additionally required for IRDs.
From a single venipuncture, two specimens are collected in separate tubes: one tube for initial HCV antibody testing; and a second tube for HCV NAT if the HCV antibody test is reactive.
The same sample of venipuncture blood used for initial HCV antibody testing, if reactive, is reflexed to HCV NAT without another blood draw for NAT (13).
A separate venipuncture blood sample is submitted for HCV NAT if the OraQuick HCV Rapid Antibody Test for initial testing of HCV antibody has used fingerstick blood.
Similarly, on page 1699, the Figure should indicate that the first kidney recipient's specimen was received by the hospital laboratory on September 19, and the positive HCV NAT
result was reported on September 20.
As of December 16, initial test results from 14 of the musculoskeletal tissue recipients were known, and all were negative based on HCV NAT.
This investigation reveals several areas in which current detection and notification might be improved to prevent similar future transplant transmission events, including: 1) consideration of the use of HCV NAT for organ donors; 2) use of algorithms or other procedures to ensure accurate reading of test results and reduce human error; and 3) timely feedback of possible disease transmission in organ or tissue recipients to organ procurement organizations, tissue banks, public health authorities, and regulators.
Going forward, all HCV NATs
will be expected to have sensitivities in the range of 10 IU/mL, and small sensitivity differences in this range will likely not be relevant for determination of SVR for patients on new highly active therapies.