J Clin Pathol Qual Control.  1998 Jun;20(1):281-287.

Evaluation of the OC-SENSOR (Automatic Measuring Apparatus) for Immunological Fecal Occult Blood Test

• Kim DC
• Cho SS
• Song J
• Kim EC
• Kim JQ

Abstract

BACKGROUND: As the incidence of gastrointestinal cancer is increasing in Korea, several trials for its early detection have been conducted. Fecal occult blood testing has been proved to be useful in mass screening of colorectal cancer. OC-SENSOR (Eiken Chemical Co., Japan) is an apparatus for quantitative determination of fecal hemoglobin by latex agglutination nephelometric immunoassay. We evaluated the performance of OC-SENSOR.
METHODS
Patient samples and standard solutions were used for evaluation. Within-run and between-day precision by both manual drop and auto drop methods of OC-SENSOR were evaluated. The prozone phenomenon and the storage effects of specimens were evaluated. OC-SENSOR method was compared with chemical method (guaiac) using 100 stool specimens.
RESULTS
Coefficients variation of within-run precision were between 2.0% and 4.3% by manual drop method and between 3.8% and 6.0% by auto drop method using patient samples. Those for manual drop method using standard solution were between 2.1% and 4.4%. The CVs of between-day precision were between 3.6% and 9.3%. The linearity was good (r=0.999). The hemoglobin concentration of 1000 microgram/mL measured 393 ng/mL by OC-SENSOR for the prozone phenomenon. When stored in usual sampling bottle (OC-SENSOR), the fecal hemoglobin concentration were decreased to 98.7% at -20degrees C, 70.8% at 4degrees C, 17.8% at room temperature on 11th day of storage. The concordance rate between OC-SENSOR and guaiac chemical method was 55%.
CONCLUSIONS
These data showed that OC-SENSOR has good performance for fecal occult blood test. While other guaiac and immunological tests are technically complicated, this new test is rather easy and time-sparing. Considering these advantages. OC-SENSOR is expected to be useful in the general laboratory and the mass screening of gastrointestinal cancer.

MeSH Terms

Agglutination
Colorectal Neoplasms
Gastrointestinal Neoplasms
Guaiac
Humans
Immunoassay
Immunologic Tests
Incidence
Korea
Latex
Mass Screening
Occult Blood*
Guaiac
Latex