title: Multiple false reactions in viral antibody screening assays after influenza vaccination.
abstract: In December 1991, US blood centers reported an unusual increase in donations that tested falsely reactive for antibodies to two or more (multiple false positive) of the following viruses: human immunodeficiency virus type 1 (HIV-1), human T-cell lymphotrophic virus type I (HTLV-I), and hepatitis C virus. Many of these donations were from people who had recently received the 1991-1992 influenza vaccine, raising the possibility that this vaccine had somehow specifically caused the problem of multiple false reactivity. A case-control study of 101 affected donors and 191 matched controls found that recent receipt of any brand of influenza vaccine was significantly associated with testing multiple false positive (p < 0.05), as was a history of recent acute illness (p < 0.05) and of allergies (p < 0.05). Surveillance for monthly rates of multiple reactive donations from May 1990 through December 1992 linked the seasonal cluster of multiple false-positive donations to the use of viral screening test kits thought to react nonspecifically to donor immunoglobulin M. There was no similar increase in multiple false-positive donations during the 1992-1993 influenza vaccination season after the HIV-1 and hepatitis C virus tests were replaced; however, the number of donations that were falsely reactive for only HTLV-I almost doubled, indicating that false reactivity was not specifically associated with the 1991-1992 influenza vaccine. Retesting of affected donors found that the duration of HTLV-I and hepatitis C virus false reactivity was 3-6 months. The cluster of multiple false-positive donations in 1991 was most likely caused by the test kits used, rather than by the influenza vaccine.
authors.affiliation: Division of Viral and Rickettsial Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
authors.forename: L
authors.initials: L
authors.lastname: Simonsen
authors.forename: J
authors.initials: J
authors.lastname: Buffington
authors.forename: C N
authors.initials: CN
authors.lastname: Shapiro
authors.forename: R C
authors.initials: RC
authors.lastname: Holman
authors.forename: T W
authors.initials: TW
authors.lastname: Strine
authors.forename: B J
authors.initials: BJ
authors.lastname: Grossman
authors.forename: A E
authors.initials: AE
authors.lastname: Williams
authors.forename: L B
authors.initials: LB
authors.lastname: Schonberger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001782:Blood Donors; D016022:Case-Control Studies; D016000:Cluster Analysis; D016001:Confidence Intervals; D005189:False Positive Reactions; D005260:Female; D015483:HIV Antibodies / Q000097:blood*; D015481:HTLV-I Antibodies / Q000097:blood*; D016174:Hepacivirus / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000097:blood*; D018937:Hepatitis C Antibodies; D006801:Humans; D007124:Immunoenzyme Techniques; D007252:Influenza Vaccines / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D015995:Prevalence; D012044:Regression Analysis; D012189:Retrospective Studies; D012307:Risk Factors; D012621:Seasons; D013997:Time Factors; D014481:United States / Q000453:epidemiology
chemical_list: D015483:HIV Antibodies; D015481:HTLV-I Antibodies; D006508:Hepatitis Antibodies; D018937:Hepatitis C Antibodies; D007252:Influenza Vaccines