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Abstract
Background
The performance of the fecal occult blood test (FOBT) has recently improved with the use of quantitative immunochemical assays. We evaluated the two latest immunochemical FOBTs: OC-Sensor PLEDIA (Eiken Chemical, Japan) and NS-Prime (Alfresa Pharma, Japan).
Methods
The precision was evaluated by using the quality control materials at two levels and carry-over rates were measured at high and low concentrations of the sample, prepared from the calibrators. Linearity was measured by using five concentrations of human hemoglobin (0-1,000 ng/mL), prepared from erythrocyte lysates. Correlation between the two systems was analyzed by testing approximately 50 selected stool specimens per day and comparing the results obtained with those of the currently used analyzer, OC-Sensor DIANA (Eiken Chemical), for 10 consecutive working days.
Results
The variation for repeatability, between-run, between-day, and intermediate precision at both levels was <5.0%, and carry-over rates were <0.01% for both systems. Linearity slopes were 0.857 and 0.594 for PLEDIA and NS-Prime, respectively, with r2>0.99 for both systems. In total, 499 stool specimens were analyzed, of which 127 (25.5%), 130 (26.1%), and 129 (25.9%) specimens tested positive by DIANA, PLEDIA, and NS-Prime, respectively. The agreement between PLEDIA and NS-Prime was 98.4%. Quantification by PLEDIA was linear to that by NS-Prime (y=1.0372x+17.744; r2=0.9064).
Figures and Tables
Fig. 1
Linearity analysis of OC-Sensor PLEDIA (A) and NS-Prime (B) using human hemoglobin (Hb) prepared from erythrocyte lysates. The trend line was determined by a linear regression of the measured Hb concentrations with target Hb concentrations.
Table 1
Analytical imprecision of OC-Sensor PLEDIA and NS-Prime
Table 2
Correlation between the results obtained by OC-Sensor PLEDIA and NS-Prime, using 499 clinical specimens
| NS-Prime | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| OC-Sensor PLEDIA | Positive | 128 | 2 | 130 |
| Negative | 1 | 368 | 369 | |
| Total | 129 | 370 | 499 | |
Table 3
Discrepant results (N=3) among OC-Sensor DIANA, OC-Sensor PLEDIA, and NS-Prime for 499 clinical specimens
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