A curious case of a negative control line on a dengue duo assay due to interference - A case report.

IF 2.1 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY
Sheila X Soh, Tze Ping Loh, Sharon Saw, Ai Teng Chong, Jia Sing Yap, Sunil K Sethi, Lizhen Ong
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Abstract

An elderly patient who presented with 1 week of fever and respiratory symptoms was tested for dengue infection with an Abbott Bioline™ Dengue Duo immunochromatographic assay. Unexpectedly, the control line of the dengue non-structural protein 1 (NS1) component was absent, necessitating result invalidation. It remained absent when the test was repeated on the SD Biosensor Standard™ Q Dengue Duo, but present on the Wells Bio careUSTM Dengue Combo and Asan Easy Test® Dengue DUO assays, suggesting potential interference. Dilution, polyethylene glycol (PEG) precipitation and centrifugation with a 100 kDa filter were performed to reduce/remove the potential interferent. Sera from other patients that showed a control line, and a test line that was either positive or negative for NS1, were used as controls. Upon dilution with negative control serum, a faint control line emerged. PEG precipitation resulted in disappearance of control and test lines in the positive control. Filtration led to emergence of the control line for the patient's serum but caused the test line for the positive control serum to disappear. Overall, investigations suggested the presence of a high molecular weight (>100 kDa) substance which interferes with chicken IgY-anti-chicken IgY binding at the control line of affected assays. Our results highlight two important points: firstly, some commonly used laboratory procedures (e.g. PEG or filtration) may inadvertently remove the target biomarker (e.g. multimeric NS1) and should be interpreted with appropriate controls. Secondly, alternative kits that use a different antigen-antibody combination for the control line can be considered when similar patients are encountered in future.

登革热二重奏检测阴性对照线受干扰的奇特病例--病例报告。
雅培 Bioline™ Dengue Duo 免疫层析检测仪对一名发烧一周并伴有呼吸道症状的老年患者进行了登革热感染检测。出乎意料的是,登革热非结构蛋白 1 (NS1) 成分的对照线缺失,结果无效。在 SD Biosensor Standard™ Q Dengue Duo 检测试剂盒上重复检测时,仍然没有对照线,但在 Wells Bio careUSTM Dengue Combo 和 Asan Easy Test® Dengue Duo 检测试剂盒上却出现了对照线,这表明可能存在干扰。稀释、聚乙二醇(PEG)沉淀并用 100 kDa 过滤器离心,以减少/去除潜在干扰物。其他患者的血清显示出对照线,而检测线则显示出 NS1 阳性或阴性,这些血清被用作对照。用阴性对照血清稀释后,出现微弱的对照线。PEG 沉淀使阳性对照中的对照线和检测线消失。过滤后,患者血清的对照线出现,但导致阳性对照血清的检测线消失。总之,研究表明,在受影响的检测中,存在一种高分子量(>100 kDa)物质干扰鸡 IgY 与抗鸡 IgY 的结合。我们的结果强调了两个要点:首先,一些常用的实验室程序(如 PEG 或过滤)可能会无意中去除目标生物标记物(如多聚体 NS1),因此应使用适当的对照来解释。其次,今后遇到类似患者时,可考虑使用不同抗原-抗体组合的替代试剂盒作为对照品。
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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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