No abstract available.
Child* ; Humans ; Occult Blood*

BACKGROUND: Fecal occult blood tests have been widely used as a means of gastrointestinal bleeding and colorectal cancer screening. HM-JACKarc (Kyowa Medex Co. Ltd, Japan) is a recently introduced automated fecal occult blood test analyser, which uses latex agglutination method. We evaluated the analytical performance of HM-JACKarc. METHODS: The linearity and precision for HM-JACKarc were evaluated according to the corresponding Clinical and Laboratory Standard Institute guidelines. The comparison study between HM-JACKarc and OC-SENSOR DIANA (Eiken Chemical Co. Ltd., Japan) was done with stool specimens. RESULTS: The linearity was good (R²=0.999) and the coefficients of variation of within-day precision and between-day precision were 5.2% and 4.9%, respectively, in low concentration and 2.7% each in high concentration. The concordance rate between HM-JACKarc and OCSENSOR DIANA was 99.0% (198 out of 200). CONCLUSIONS: HM-JACKarc showed excellent performance in linearity, precision, and comparison studies. Therefore, it appears to be a useful automated fecal occult blood test analyser.
Agglutination ; Colorectal Neoplasms ; Hemorrhage ; Latex ; Mass Screening ; Methods ; Occult Blood*

BACKGROUND: Fecal occult blood tests (FOBT) have been recommended for gastro- intestinal bleeding and colon cancer screening. This study compared the effectiveness of two fecal blood screening kit, OC-Hemodia II and Ez step FOB for fecal occult blood. METHODS: The detection limit was evaluated by using OC-control and serially diluted samples. The comparison study between OC-hemodia II and Ez step FOB were evaluated in 143 cases. RESULTS: The concordance rate between OC-Hemodia II and Ez step FOB was 85.6% and 50% of non-concordance cases have history related to gatrointestinal bleeding. Ez step FOB was possible to detect 35 ng/mL in serially diluted OC-control. CONCLUSIONS: The result of Ez step FOB satisfactory to clinical application and showed good concordance rate compared to OC-Hemodia II.
Colonic Neoplasms ; Hemorrhage ; Limit of Detection ; Mass Screening ; Occult Blood*

The pathogenesis of intestinal atresia has shown well that mesenteric vascular insults during an intrauterine life played an important role, and it has been shown in animal experiments. Intrauterine intussusception was suggested as one of the etiologies that cause jejunoileal atresia. The aims of this study were 1) to see if polypoid lesions in congenital ileal atresia were associated with intrauterine intussusception and 2) to make diagnostic criteria for possible intrauterine intussusception. Intraluminal polypoid lesions were found in three patients with congenital ileal atresia. They were Louw classification type I in two patients, and type II in one patient. Two lesions were composed of intestinal wall layers contiguous with adjacent small bowels, however, atrophic non-viable tubular structure was found in one patient. All of this signifies that they were a remnant of an intrauterine intussusception which had occurred in a different developmental stage. In conclusion, intraluminal polypoid lesion in ileal atresia was suggested to be the remnant structure of intrauterine intussusception. Such instances were highly suggested by the followings: 1) type I or II in Louw classification 2) intraluminal polypoid lesion adjacent to atretic portion, 3) identifiable intestinal wall layers in histologic examination, 4) positive occult blood in meconium.
Animal Experimentation ; Classification ; Humans ; Intestinal Atresia ; Intussusception* ; Meconium ; Occult Blood

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). CONCLUSIONS: The analytical performances of PLEDIA and NS-Prime warrant their use as diagnostic tests. They showed excellent categorical agreement; however, the quantitative value obtained by NS-Prime was lower than that obtained by PLEDIA.
Diagnostic Tests, Routine ; Erythrocytes ; Humans ; Occult Blood* ; Quality Control

BACKGROUND: Fecal occult blood test is a useful method for mass screening of colorectal cancer. HM-JACK is automatic analyzer for detecting fecal occult blood with latex agglutination methods. We evaluated its apparatus for compatibility for clinical testing. METHODS: The linearity, precision and effect of temperature and container in stool storage were evaluated. The comparison study with OC-Hemodia and prozone phenomenon were evaluated. RESULTS: The linearity was good(R(2)=0.997) and coeffiecinet variation(CV) of within-day precision were 4.6% and 2.6% in low concentration and high concentration. The CV of between-day precision were 4.8% and 3.5%. The hemoglobin concentration of 0.1 g/dL(1x10(6) ng/mL) was measured to 651 ng/mL for Antigen excess zone. The hemoglobin were more decreased in room temperature storage and usual container storage than in low temperature storage and HM-JACK container storage. The concordance rate between HM-JACK and OC-Hemodia was 90%. CONCLUSION: HM-JACK showed good performance for linearity, precision and comparison study. Therefore, it can be used effectively in clinical laboratory due to convenience, and possibility of quantitation and fast reporting.
Agglutination ; Colorectal Neoplasms ; Latex ; Mass Screening ; Occult Blood*

The fecal immunochemical test (FIT) is the initial non-invasive investigation of choice for population-based colorectal cancer (CRC) screening. We evaluated the positivity rate in repeated tests using the same fecal specimen that showed borderline results in the FIT. A total of 6,465 patients were tested with the FIT in a tertiary-care hospital from July to December 2016. FIT was done using OC-Sensor PLEDIA (Eiken Chemical Co., Tokyo, Japan). Among 6,465 patients, 364 (5.6%) patients showed a positive FIT result of over 20 µg Hb/g feces. A total of 112 (1.7%) patients showed borderline scores of 10.2–20 µg Hb/g feces, and 5,989 (92.6%) patients showed negative results of less than 10 µg Hb/g feces. Among the 101 repeat-tested patients, 19 (18.8%) of the patients' scores converted to levels above the positive cut-off threshold. Repeated results of 19 patients showed score elevations from 20.2 to 68 µg Hb/g feces. These results suggest that it is most important to analyze properly prepared samples, even if only once. Therefore, the laboratory staff should ensure the proper preparation of stool specimens for FIT. Laboratory directors should choose the best cut-off value for detecting CRC at their respective institutions.
Colorectal Neoplasms ; Feces ; Humans ; Mass Screening ; Occult Blood

BACKGROUND: Fecal occult blood tests have been widely used to screen for colorectal cancer. SENTiFIT 270 (Sentinel diagnostics, Italy) is a fecal occult blood test with an immunochemical method that utilizes FOB Gold reagents. We evaluated the performance of SENTiFIT 270 using the FOB Gold reagent. In addition, FOB Gold was evaluated with the HITACHI 7180 (Hitachi Ltd., Japan). METHODS: The precision and linearity of the SENTiFIT 270 was evaluated in accordance with applicable Clinical and Laboratory Standard Institute guidelines. The comparison study between SENTiFIT 270-FOB Gold and the OC-Sensor (Eiken chemical Co., Japan) was performed using stool specimens. RESULTS: In the precision evaluation, the total precision of SENTiFIT 270-FOB Gold was 4.94% and 2.54% at high and low concentrations, respectively. The HITACHI 7180-FOB Gold had excellent precision of 4.60% and 2.09% at high and low concentrations, respectively. Linearity was also excellent for the SENTiFIT 270-FOB Gold and HITACHI 7180-FOB Gold at 0.9987 and 0.9986, respectively. The SENTITIF 270-FOB Gold showed excellent agreement with a kappa value of 0.830 and a concordance rate of 93.6%. The HITACHI 7180-FOB Gold showed high agreement with a kappa value of 0.832 and a concordance rate of 93.9%. CONCLUSION: The SENTiFIT 270-FOB Gold showed excellent performance in accuracy, linearity, and comparative inspection ability.
Colonic Neoplasms ; Colorectal Neoplasms ; Indicators and Reagents ; Methods ; Occult Blood

OBJECTIVETo assess the accuracy of immunological fecal occult blood test (iFOBT) for detection of colorectal cancer (CRC).

METHODSA total of 1 197 studies published before June 2014 were selected from PubMed and Embase and 17 of which were finally included in this meta-analysis. A bivariate mixed-effects models was used for overall value merging and heterogeneity testing. In addition to the overall sensitivity and specificity, the analyses were also performed among certain subgroups, including a "colonoscopy group" (all were referred for colonoscopy diagnosis regardless screening results) and a "follow-up group" (only the screening positive were referred and all were then followed up), a qualitative group and a quantitative group (classified by the way of iFOBT result reading).

RESULTSA total of 161 502 subjects aged from 48 to 63 years were included in the analysis. IFOBT had an overall integrated sensitivity of 0.85 (95% CI: 0.79-0.89) (heterogeneity test: Q = 59.67, P < 0.001) and an overall integrated specificity of 0.93 (95% CI: 0.92-0.94) (heterogeneity test: Q = 1 722.53, P < 0.001) for detection of CRC. In the subgroup analysis, it was found that in the "colonoscopy group" and in the "follow-up group", the sensitivity were 0.81 (95%CI: 0.73-0.87) and 0.88 (95% CI: 0.81-0.92), respectively; the specificity were 0.92 (95% CI: 0.89-0.93) and 0.95 (95% CI: 0.94-0.96), respectively. It was also found that in the qualitative group and the quantitative group, the sensitivity were 0.84 (95% CI: 0.76-0.90) and 0.86 (95% CI: 0.78-0.92), respectively; the specificity were 0.94 (95% CI: 0.91-0.96) and 0.93 (95% CI: 0.91-0.94), respectively.

CONCLUSIONIFOBT had high overall sensitivity and specificity for detecting colorectal cancer.

Colorectal cancer (CRC) is the fourth most common cause of cancer death in China and the incidence has been increasing during the decades. It is reported to take decades for adenoma to transform to carcinoma, which is known as the main CRC pre-cancer lesion. It is important to carry out mass screening in the average risk populations to find the pre-cancer lesion and early cancer, which was the key approach to improve CRC survival. Fecal occult blood test and flexible sigmoidoscopy are the two CRC screening methods, which have been shown to reduce CRC mortality. It still needs to be confirmed in random clinical trials that the value of colonoscopy in CRC screening. In China, the most CRC screening experience was drawn from the works in Zhejiang province in 1970s. Consequently, the Chinese CRC treatment and guideline was founded to provide standard for the CRC screening project.
Adenoma ; China ; Colonoscopy ; Colorectal Neoplasms ; Early Detection of Cancer ; Humans ; Incidence ; Mass Screening ; Occult Blood ; Sigmoidoscopy