Sample comparison of BÜHLMANN fCAL Turbo and OC-FCa faecal calprotectin methods.

IF 2.1 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Annals of Clinical Biochemistry Pub Date : 2024-08-14 DOI:10.1177/00045632241273266
Shane O'Driscoll, Carolyn Piggott, Sally C Benton
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Abstract

Background: Faecal calprotectin is an inflammatory marker used to triage patients for further investigation with suspected inflammatory bowel disease (IBD). Our current method requires faecal samples be sent to the laboratory, where calprotectin is extracted before analysis. This is a time-consuming, potential bottleneck in the pathway. We have recently evaluated the OC-SENSOR PLEDIA fCAL method that uses the same sampling device as used in some bowel cancer screening and symptomatic colorectal cancer programmes that detect faecal haemoglobin. The below study is a comparison of the OC-FCa method with the BÜHLMANN fCAL Turbo which is used routinely within BSPS.

Method: 150 homogenised and 110 non-homogenised faecal samples were loaded into OC-Sampling Bottle 3 and BÜHLMANN CALEX cap sampling devices. The samples were then analysed on their respective systems according to manufacturer's instructions.

Results: The OC-FCa assay had a mean positive bias of 67.3% (homogenised) and 88.4% (non-homogenised). Homogenised samples showed substantial agreement between the methods for normal (<50 µg/g) and elevated (150+µg/g) risk categories (k = 0.794, k = 0.788, respectively) and moderate agreement for borderline (51-150 µg/g) (k = 0.25) according to the current Berkshire and Surrey Pathology Service (BSPS) guidelines. Non-homogenised samples had none to slight agreement for normal and borderline values (k = 0.02 for both) and moderate agreement for elevated (k = 0.596).

Conclusion: The OC-FCa method is a viable alternative for faecal calprotectin testing, but requires an adjustment to clinical cut-off values due to the lack of standardisation and strong positive bias. A clinical comparative study is required to assess the impact of patients collecting their own samples into the devices, as this may negate any potential degradation samples may exhibit during transit to the laboratory.

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BÜHLMANN fCAL Turbo 和 OC-FCa 粪热蛋白检测法的样本比较。
背景:粪便钙蛋白是一种炎症标志物,用于对疑似 IBD 患者进行分流,以便进一步检查。我们目前的方法需要将粪便样本送至实验室,在分析前提取钙蛋白。这是一个耗时的潜在瓶颈。我们最近对 OC-SENSOR PLEDIA fCAL 方法进行了评估,该方法使用的采样装置与一些肠癌筛查和有症状的结直肠癌项目中使用的采样装置相同,都是用来检测粪便血红蛋白的。以下研究比较了 OC-FCa 方法和 BSPS 常规使用的 BÜHLMANN fCAL Turbo 方法:方法:将 150 份均质粪便样本和 110 份非均质粪便样本分别装入 OC 采样瓶 3 和 BÜHLMANN CALEX 盖采样装置。然后根据制造商的说明在各自的系统中对样本进行分析:结果:OC-FCA 分析法的平均阳性偏差为 67.3%(均质化)和 88.4%(非均质化)。均质化样本的正常值与两种方法的正常值基本一致:OC-FCa 方法是粪便钙粘蛋白检测的可行替代方法,但由于缺乏标准化和较强的阳性偏倚,需要对临床临界值进行调整。需要进行临床比较研究,以评估患者将自己的样本收集到设备中的影响,因为这可能会抵消样本在运送到实验室过程中可能出现的任何降解。
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来源期刊
Annals of Clinical Biochemistry
Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry
CiteScore
5.20
自引率
4.50%
发文量
61
期刊介绍: Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine. Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals. Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).
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