Mahto Mala, Banerjee Ayan, Kumar Mukunda, Kumar Sushil, Pandey Jagjit
Biochemistry Central Lab, Biochemistry Department, AIIMS Patna, IPD Building, D block, 4th floor, Patna, Bihar 801507 India.
Surgical Oncology Department, AIIMS Patna, Patna, India.
Indian J Clin Biochem. 2023 Jan;38(1):142-147. doi: 10.1007/s12291-021-00970-5. Epub 2021 Mar 25.
Varying reports across different laboratories or across different analysers in the same lab for the same sample is not an uncommon phenomena. Experts call this a lack of harmonization. A test that is harmonized provides the same results regardless of the manufacturer of reagents used or the laboratory where the test is performed. When laboratory tests are not harmonized, the entire continuum of patient care can be affected in a number of ways. Here, we present a case of varying reports for a single serum human chorionic gonadotropin (hCG) sample on two different immunoassay platforms for a young female presenting with an abdominopelvic mass. The lab reports for serum hCG for this particular patient showed inconsistent results with the same sample within the same lab. The phenomena behind this was lack of harmonization of test results. We introspect many of the factors responsible for lack of uniformity in hCG results amongst the major ones being with use of antibodies directed against different epitopes of hCG (analyte) and the heterogeneity of the hCG molecule itself. Harmonization is a process to ensure that different clinical testing procedures used by different laboratories give equivalent results. Harmonizing test results will enable healthcare providers to use clinical guidelines with greater confidence for diagnosing disease and managing patients.
对于同一标本,不同实验室之间或同一实验室的不同分析仪给出不同结果,这并非罕见现象。专家称此为缺乏一致性。经过一致性验证的检测,无论使用何种试剂制造商的试剂,也无论在哪个实验室进行检测,都能得出相同结果。当实验室检测缺乏一致性时,患者护理的整个连续过程可能会在多个方面受到影响。在此,我们呈现一例年轻女性腹部盆腔肿物患者的血清人绒毛膜促性腺激素(hCG)单一标本在两种不同免疫分析平台上出现不同报告的案例。该特定患者血清hCG的实验室报告显示,同一标本在同一实验室得出了不一致的结果。其背后的现象是检测结果缺乏一致性。我们反思了导致hCG结果缺乏一致性的诸多因素,其中主要因素包括使用针对hCG(分析物)不同表位的抗体以及hCG分子本身的异质性。一致性是确保不同实验室使用的不同临床检测程序得出等效结果的过程。使检测结果具有一致性将使医疗服务提供者能够更有信心地使用临床指南来诊断疾病和管理患者。