3-13. SELECTION OF DONORS
A review of some of the donor selection criteria is given in Lesson 1.
a. History and Physical Examination. Specific questions should be designed
to detect a history of past or present hepatitis in the donor or close relatives (or other
close contact with the disease), recent transfusion of blood components (or derivatives),
recent tissue graft, and use of, or exposure to, potentially contaminated needles. The
type of patient contact most hospital personnel have in their routine work is not
considered "close contact" and such work is not a cause for donor exclusion; however,
blood donors in close contact with individuals with viral hepatitis, for example, their
spouses, should be excluded from donating blood for 6 months from the time of last
exposure. Physical examination must include inspection of both arms for evidence of
drug abuse.
b. Payment of the Blood Donor. It has been demonstrated that unpaid donors
are to be preferred as there is no increased risk (5 to 15 times) of post transfusion
hepatitis following the transfusion of blood from commercial source (paid donor) when
compared to unpaid donors' blood. Payment for blood, per se, does not affect the
quality of the blood of course, but this practice may attract undesirable donors, such as
alcoholics or drug addicts, in whom the risk of hepatitis is high. In addition, the
commercial donor is less likely to be reliable in terms of giving an accurate history of his
present and past health.
3-14. TESTING FOR HEPATITIS B SURFACE ANTIGEN AND HEPATITIS C
IN BLOOD
a. General.
(1) The AABB Standards require that all donor blood be tested for hepatitis
B surface antigen (HBsAg) and hepatitis C (HCV). This is also a requirement of the
Bureau of Biologics of the Food and Drug Administration (FDA). Hepatitis B surface
antigen and HCV testing must use reagents and techniques specified by FDA or proven
to have equivalent sensitivity and specificity. The FDA regulation states that all donor
blood "shall be tested for the presence of the hepatitis B surface antigen by a method of
sufficient sensitivity to detect all serums labeled A, (A), B, (B), and C in the Reference
Hepatitis B Surface Antigen Panel, distributed by the Bureau of Biologics, except that, in
emergency situations, a test method of sufficient sensitivity to detect all serums labeled
A, (A), and B in the Reference Hepatitis B Surface Antigen Panel may be used." Thus,
the most sensitive "third generation " test, such as radioimmunoassay (RIA) or reversed
passive hemagglutination (RPHA), must be used for routine testing, while the less
sensitive "second generation " tests, such as counterelectrophoresis (CEP) and latex
agglutination, may be used in "emergency situations". The FDA regulation applies to
blood or components for transfusion, to production of derivatives for transfusion, to
manufacture of reagents for laboratory use, and to blood used for stimulation of
antibody(ies) in donors.
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