粪便血红蛋白定性免疫化学检测 (FIT) 可用于对结直肠癌研究进行分类，可供专业人士使用。目的是评估这些侧向层析测试。以前没有发表过分析评估。分析灵敏度 (AS) 是使用制造商引用的 AS 样品与定量 OC-SENSOR PLEDIA 一起评估的，使用制造商缓冲液中的 Hb 加标样品（n≥5；≤9-99） ng Hb/mL 缓冲液）、加 Hb 的粪便（n=6；<2-34μg Hb/g 粪便）和天然粪便（n=17；<2-82μg/g）；将检测到的 50%/100% Hb 浓度与引用的 AS 进行比较。测试了与两种外部质量评估方案 (EQAS) (n=9; 3-96μg/g) 的兼容性以及与制造商限值 (n=9; 2,500-10,000,000ng/mL) 相比的 prozone。评估了五名医护人员的易用性。与 OC-SENSOR 相比，使用 Hb 加标水样时，七种产品的 AS (ng/mL) 低于制造商报价，其中一种是模棱两可的；另一种是模棱两可的。六家制造商以 µg/g 为单位引用 AS，其中 5 家制造商使用加有 Hb 的粪便显示更低的 AS。自然粪便的结果相似，但不太一致。低浓度的结果线可能很模糊并且易于解释。结果与制造商引用的前带限值一致。两种 EQAS 的七种产品的结果是一致的。易用性为68.5-85.6%；得分较低的产品可以通过更好的说明和样品瓶进行改进。与 OC-SENSOR 相比，七种产品（水样）和五种产品（水样/粪便样品）的 AS 较低，前带与制造商预期浓度一致。 EQAS 结果与预期结果基本一致；尽管制造商可以进行一些改进，但产品可供医疗保健专业人员使用。© 2024 Walter de Gruyter GmbH，柏林/波士顿。

Qualitative faecal immunochemical tests for haemoglobin (FIT), for triaging for colorectal cancer investigations, are available for professional use. The aim was to evaluate these lateral flow tests. No previous analytical evaluations have been published.Analytical sensitivity (AS) was assessed using samples spanning manufacturers' quoted AS, concurrently with the quantitative OC-SENSOR PLEDIA, using Hb-spiked samples in manufacturers' buffer (n≥5; ≤9-99 ng Hb/mL buffer), Hb-spiked faeces (n=6; <2-34 µg Hb/g faeces) and natural faeces (n=17; <2-82 μg/g); concentrations for 50 %/100 % Hb-detected were compared with quoted AS. Compatibility with two external quality assessment schemes (EQAS) (n=9; 3-96 μg/g) and prozone compared with manufacturers limits (n=9; 2,500-10,000,000 ng/mL) were tested. Ease-of-use by five healthcare personnel was assessed.Seven products showed lower AS (ng/mL) than manufacturers quoted using Hb-spiked aqueous samples compared with OC-SENSOR, one was equivocal; six manufacturers quoted AS in µg/g, five showed lower AS using Hb-spiked faeces. Results were similar but less consistent for natural faeces. Result lines for low concentrations can be faint and open to interpretation. Results were consistent with manufacturers quoted prozone limits. Results were consistent for seven products for two EQAS. The ease-of-use was 68.5-85.6 %; products with lower scores could be improved with better instructions and sample bottles.AS was lower for seven products (aqueous samples) and five products (aqueous/faecal samples) and prozone consistent with manufacturers expected concentrations, compared with OC-SENSOR. EQAS results were mostly consistent with expected results; products can be used by healthcare professionals, though some manufacturer improvements could be made.© 2024 Walter de Gruyter GmbH, Berlin/Boston.