An Epidemiological and Clinical Study of Transaminase Levels and Hepatitis B Antibodies in 1,100 Blood Donors

Abstract

In order to provide epidemiological and clinical information on surrogate testing of blood donations, the respective prevalences of serum hepatitis B virus (HBV) markers and elevated transaminase levels were studied in 1,100 blood donors according to their geographic origin and socioeconomic level. The frequency of serum HBV markers varied as a function of HBV endemicity in the country of origin; however, it was inversely correlated (p<0.05) to the socioeconomic level of the donors, even in those originating from countries of low HBV endemicity. There was no association between serum HBV markers and the increased transaminase level which was observed in 48 (4.3%) donors. Twenty-five of these accepted further clinical evaluation. A diagnosis appeared probable in 12 of the 25; alcohol in 5; drugs in 6; non-A, non-B hepatitis in 1. Seven of the remaining 13 subjects were more than 25% above ideal body weight. Transaminase activities determined at the time of clinical assessment were normal in 14. In addition, serum HBV DNA was found in 5 of 247 donors, even in the absence of any usual HBV marker and/or hypertransaminasemia. This could account for the few cases of B and B-like posttransfusion hepatitis which are known to still occur despite careful HBsAg screening of blood donors.

High Prevalence of HBV Infectivity in Blood Donors Detected by the Dot Blot Hybridisation Assay

“…Thus, PCR by its high sensitivity may be detecting viremia less than the infective dose. HBV DNA was also found in 5 of 247 donors negative for all serological markers of HBV infection and normal ALT in France [3]. In the only other study from India, in which HBV DNA was detected in 24% of 126 HBsAg-negative blood donors by PCR [14], a good correlation was reported between HBV DNA positivity and anti-HBc; however, ALT was not evaluated.…”

“…The exact relationship of ALT elevation with incidence of PTH-B in different countries with low, intermediate and high prevalence rates of HBV is not clear. In France 2.7% of blood donors had an elevated ALT [3] while their HBV carrier rate was 0.2-0.59'0 [4]; in Sardinia these rates were 4 and 3%, respectively [5]. However, since blood units with elevated ALT levels cause PTH more often than those with normal ALT [3], it appears important to determine the role of testing of ALT and other surrogate markers in areas with intermediate and high HBV carrier rates.…”

Prevalence and Consistency of ALT Elevation in Plasmapheresis Donors: Implications for the Assessment of Blood Product Infectivity

“…1.3-12% of donations, less than a third of which may be infective) might prevent about 30% of PTH [ 1 4 , 10-151. Doubts have been expressed as to whether this expectation has been fulfilled (5,16,171 and this has been difficult to assess in the absence of prospective studies. In countries with low endemic rates of nonA, nonB hepatitis, it has been suggested that ALT screening may be of minimal benefit with most ALT elevations being due to non-viral causes such as obesity [12,15] or failure to apply appropriate cutoff levels for the differences that occur between sexes [3,4,.…”

“…Concern has also been expressed over the potential impact on donor deferral or exclusion rates of serial ALT testing of long-standing or frequently donating donors. If ALT elevation is an essentially random event, rather than occuring consistently in a few identifiable donors, it has been estimated that up to 50% of a donor panel might be lost over a 10-year-period for groups such as plasmapheresis donors who give blood frequently [5]. The limited duration studies that have been performed to date indicate persistent ALT elevation in 25-66%, and intermittent elevation of 30-80% of such donors [4,5,14,29,30].…”

“…Testing of blood donations for alanine aminotransferase (ALT) levels has been introduced by some transfusion services for two reasons: as a surrogate marker for nonA, nonB hepatitis in blood donors and as a diagnostic criterion for post-transfusion hepatitis (PTH). For the former, ALT testing has a relatively low specificity and sensitivity [ 1-41, and concern has been expressed that the relatively high level of false-positive results may lead to rejection of healthy donors, particularly those who repeatedly donate, if elevation of ALT is a purely random event [5]. The recently reported multicentre study of routine blood (as opposed to plasmapheresis) donors of Anderson et al [6] is probably more relevant to the potential impact of introduction of ALT testing of blood donors in the UK.…”