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1996-02-26
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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).