Performance of immunochemical faecal occult blood test in colorectal cancer screening in average-risk population according to positivity threshold and number of samples.

Immunochemical faecal occult blood tests (I-FOBT) detect more effectively advanced neoplasia than guaiac tests (G-FOBT). The study aim was to compare the performance of an I-FOBT whilst varying the positivity threshold and considering four analysis modalities: one sample was performed (MG(1)), two samples were performed and at least one sample was positive (MG(2+)), both samples were positive (MG(2++)) or the mean of the two samples' log-transformed haemoglobin contents exceeded the cutoff (MG(2m)). Screening for colorectal cancer using both G-FOBT and two samples' I-FOBT was performed by an average-risk population sample of 20,322 subjects. Among the 1,615 subjects with at least one positive test, 1,277 had a satisfactory colonoscopy result; 43 invasive cancers and 270 high-risk adenomas were detected. The I-FOBT was reinterpreted under each analysis modality (a random selection of one sample led to MG(1)). For all modalities, increasing the positivity threshold decreased sensitivity and increased specificity. The relative ROC curves (in reference to G-FOBT) demonstrated similar performance for MG(1) and MG(2+), and improved performance for MG(2m). MG(2++) sensitivity was limited within the range of positivity thresholds evaluated. For any specificity, MG(2m) provided the highest sensitivity. For any sensitivity, MG(2m) provided the highest specificity. For any positivity rate, MG(2m) provided both the highest sensitivity and specificity. This study suggests the replacement of MG(2+) by MG(1) or, for even better performance, by MG(2m) provided that two samples are performed with similar participation (which should be explored). The targeted positivity rate could then be achieved by choosing the positivity threshold.

Usefulness of the hepatitis C virus core antigen assay for screening of a population undergoing routine medical checkup.

We studied the usefulness of the recently designed Trak-C assay for the detection and quantification of the hepatitis C virus (HCV) core antigen (Ag) for the screening of HCV infection in 4,201 subjects selected from 74,150 consecutive volunteers undergoing routine medical checkups. Subjects were selected for screening because they had risk factors (group II, n = 321) and/or elevated alanine transaminase activity (group I, n = 3847). Initially, the anti-HCV antibody assay and the Trak-C assay were performed on each patient. Subsequently, the Trak-C assay was performed only when the anti-HCV enzyme immune assay (EIA) was positive. Positive samples were further evaluated for anti-HCV antibodies by a third-generation strip immunoblot assay and for HCV RNA. Four samples (1.2%) from group II and 113 (2.9%) from group I were anti-HCV EIA positive. We also tested 33 subjects who previously tested positive for anti-HCV in our medical center. Among the 150 anti-HCV EIA-positive samples, the HCV core Ag result was in accord with the HCV RNA result in 146 cases (97.3%). When the EIA result was positive, the HCV core Ag concentration and the HCV RNA load were correlated (r(2) = 0.78; P < 0.001). Four samples with low viral loads were Trak-C negative but HCV RNA positive. Among the 2,395 anti-HCV EIA-negative serum samples collected during the first part of the study, 17 (0.7%) were found to contain very low levels of HCV core Ag (<8.5 pg/ml, the cutoff value being 1.5 pg/ml). All these samples were HCV RNA negative and considered to be false positives. This was confirmed by HCV core Ag neutralization analysis. The HCV core Ag assay is a useful method in the screening strategy of HCV infection and provides a reliable means of distinguishing between current and cleared HCV infections that is well correlated with HCV RNA testing.