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Titolo:
EVALUATION OF THE COBAS CORE IMMUNOASSAY FOR MEASURING PROSTATE-SPECIFIC ANTIGEN (PSA) - MULTICENTER STUDY RESULTS
Autore:
SCHAMBECK CM;
Indirizzi:
UNIV WURZBURG,MED KLIN,ZENT LAB,JOSEF SCHNEIDER STR 2 D-97080 WURZBURG GERMANY
Titolo Testata:
European journal of clinical chemistry and clinical biochemistry
fascicolo: 8, volume: 33, anno: 1995,
pagine: 541 - 547
SICI:
0939-4974(1995)33:8<541:EOTCCI>2.0.ZU;2-P
Fonte:
ISI
Lingua:
ENG
Soggetto:
TUMOR-MARKER; SERUM; CANCER; ASSAY; STANDARDIZATION; TIME;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
26
Recensione:
Indirizzi per estratti:
Citazione:
C.M. Schambeck, "EVALUATION OF THE COBAS CORE IMMUNOASSAY FOR MEASURING PROSTATE-SPECIFIC ANTIGEN (PSA) - MULTICENTER STUDY RESULTS", European journal of clinical chemistry and clinical biochemistry, 33(8), 1995, pp. 541-547

Abstract

Hoffmann-La Roche has introduced a fully automated COBAS CORE EIA forthe measurement of prostate specific antigen (PSA). A regular and an ultrasensitive version of the assay are available. Both versions of the COBAS CORE PSA EIA were compared with the established IMx PSA assay from Abbott. Sera from 98 apparently healthy males, 224 patients with benign prostate hyperplasia, 17 patients with prostatitis and 111 patients with prostate cancer were determined using the COBAS CORE PSA EIAin comparison with the IMx PSA assay. The sera were drawn before treatment. Sera from 26 patients were also monitored through follow-up testing. The COBAS CORE analyser allows rapid analysis of large series ofsamples. Intra-assay imprecision (CV) was between 1.7% and 4.9% (IMx PSA: between 2.4% and 2.7%). The coefficient of variation for inter-assay imprecision was between 3.4% and 6.5% (IMx PSA: between 3.2% and 3.3%). The analytical detection limit was determined as 0.2 mu g/l for the regular COBAS CORE PSA EIA and 0.05 mu g/l for the ultrasensitive version. A biological detection limit of 0.1 mu g/l was determined forthe ultrasensitive version. Results obtained using the COBAS CORE PSAEIA and IMx PSA assays were in excellent correlation: coefficient of correlation r = 0.99 and slope = 0.92, using prostate-specific antigenvalues from the complete study. Only in the measuring range below 10 mu g/l did the coefficients of correlation vary between 0.82 and 0.93. The diagnostic sensitivity for both assays is approximately the same:at a specificity of 95% with regard to benign prostate hyperplasia, the COBAS CORE PSA EIA showed a sensitivity of 41% and the IMx PSA assay a sensitivity of 47%. In the follow-ups of all 26 patients, the two assays showed very good correspondence. The regular COBAS CORE PSA EIAperforms similarly to the IMx PSA assay with respect to reproducibility and diagnostic sensitivity. Values from both assays compare well with each other. The biological detection limit for the ultrasensitive version of the COBAS CORE PSA EIA differs only slightly from that for the IMx PSA assay.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/09/20 alle ore 12:12:02