       Document 0937
 DOCN  M9620937
 TI    Hemoconcentration prior to serology testing in hemodiluted cadaver bone
       and tissue donors.
 DT    9602
 AU    LeFor WM; Shires DL Jr; McGonigle AF; Shires DL 3rd; Transplantation
       Immunology Laboratory, LifeLink Foundation, Inc.,; Tampa, Florida, USA.
 SO    Clin Transplant. 1995 Aug;9(4):297-300. Unique Identifier : AIDSLINE
       MED/96039205
 AB    Concern about false negative serology tests for infectious diseases in
       hemodiluted cadaver donors resulted in issuance of new regulations and
       guidelines from the FDA and CDC. Bone or tissue from donors receiving >
       or = 4 units of blood, blood products, colloids or crystalloids within
       48 h of sampling must be quarantined unless: (a) a pretransfusion serum
       is available; or (b) an adequate algorithm is employed to ensure
       hemodilution is insufficient to alter test results, i.e. cause false
       negatives. Left undefined in these regulations is, what is an adequate
       algorithm and what amount of hemodilution would cause false negatives. A
       pretransfusion sample was not available for about 20% of our donors and
       many had incomplete infusion histories. We used the unambiguous
       quantitation of serum albumin and total protein to define hemodilution
       and, if present, hemoconcentration of sera by ultrafiltration to normal
       protein levels prior to serology testing. Control experiments showed
       excellent correlation between serum dilution and protein concentration
       (r > 0.99) and a quantitative recovery of 96.9 +/- 1.4% upon
       hemoconcentration. Known positive sera (CMV-Ab; HTLV-1Ab; HIV-1,2Ab;
       HBsAb; HCV-Ab; HBsAg) were spiked into normal sera and diluted up to
       1:2000, well beyond detectable levels. A qualitative recovery of 100%
       and a quantitative recovery of 97.6 +/- 7.5% of antibody or antigen
       reactivity was achieved upon hemoconcentration and retesting. In two
       studies, 14% (30/210) and 43% (23/54) of cadaver donors had serum
       proteins below normal limits and their sera was
       hemoconcentrated.(ABSTRACT TRUNCATED AT 250 WORDS)
 DE    Algorithms  Antibodies, Viral/BLOOD  Blood Proteins/ANALYSIS  Blood
       Substitutes/THERAPEUTIC USE  Blood Transfusion  *Bone Transplantation
       *Cadaver  Colloids/THERAPEUTIC USE  Communicable
       Diseases/BLOOD/*DIAGNOSIS  Cytomegalovirus/IMMUNOLOGY  False Negative
       Reactions  *Hemodilution  *Hemofiltration  Hepatitis B Antibodies/BLOOD
       Hepatitis B Surface Antigens/BLOOD  Hepatitis C Antibodies/BLOOD  Human
       HIV Antibodies/BLOOD  HTLV-I Antibodies/BLOOD  Plasma
       Substitutes/THERAPEUTIC USE  Rehydration Solutions/THERAPEUTIC USE
       Sensitivity and Specificity  *Serodiagnosis  Serum Albumin/ANALYSIS
       *Tissue Donors  *Tissue Transplantation  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

