Comparison of two anti-hepatitis C virus enzyme-linked immunosorbent assays: Wellcozyme VK45 and Ortho 2.0.
BACKGROUND
The aim of the present study was to compare 2 anti-HCV ELISA tests with respect to sensitivity and specificity in detecting Hepatitis C antigen.


METHODS
A 3rd-generation anti-HCV ELISA (Wellcozyme anti-HCV VK45) was compared with a 2nd-generation anti-HCV ELISA (Ortho HCV 2.0) in various serum panels: A) anti-HCV ELISA-positive samples of blood donations (n = 536), B) non-A, non-B hepatitis patients (n = 188), C) multi-transfused patients (n = 79), D) hemodialysis patients (n = 473), and E) random blood donors (n = 1,080).


RESULTS
Of 248 cDNA polymerase chain reaction (cDNA-PCR) positive samples in panels A, B, and C, ELISA-VK45 detected 247 (99.6%) and Ortho-2 248 (100%). The cDNA-PCR-positive sample missed by ELISA-VK45 showed isolated anti-C33c reactivity in a 2nd-generation recombinant immunoblot (RIBA-2). Of 281 RIBA-2-positive samples, ELISA-VK45 detected 274 (97.5%) and Ortho-2 279 (99.3%). ELISA-VK45-negative, RIBA-2-positive samples showed combined anti-C100/5-1-1 reactivity in RIBA-2 in 6/7 cases and anti-C22 and C33c reactivity in one. Ortho-2-negative, RIBA-2-positive samples showed combined anti-C100/5-1-1 reactivity in RIBA-2 in 2/2 cases. The specificities of ELISA-VK45 and Ortho-2 were not significantly different in 1,080 blood donors.


CONCLUSIONS
It is concluded that the ELISA-VK45 lacks sensitivity because a cDNA-PCR-confirmed positive sample was missed in the assay. The specificity of both ELISAs was comparable.
Vrielink
H
H
Rode Kruis Bloedbank Amsterdam, The Netherlands.
van der Poel
C L
CL
Reesink
H W
HW
Lelie
P N
PN
D000328:Adult; D000368:Aged; D000956:Antigens, Viral / Q000097:blood*; D001782:Blood Donors; D001803:Blood Transfusion; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006526:Hepatitis C / Q000175:diagnosis* / Q000276:immunology / Q000517:prevention & control; D018936:Hepatitis C Antigens; D006801:Humans; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D012016:Reference Values; D006435:Renal Dialysis
D000956:Antigens, Viral; D018936:Hepatitis C Antigens