PMID- 36186265
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221004
IS  - 0974-2727 (Print)
IS  - 0974-7826 (Electronic)
IS  - 0974-2727 (Linking)
VI  - 14
IP  - 1
DP  - 2022 Mar
TI  - An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: 
      Validation of a Modified-Approved Method for Accreditation by the College of 
      American Pathologists.
PG  - 11-15
LID - 10.1055/s-0041-1733817 [doi]
AB  - Background  Human chorionic gonadotropin (hCG) detection in cerebrospinal fluid 
      (CSF) can provide additional value in the diagnosis of germinoma. However, matrix 
      effects can influence the results when alternative sample types are used. 
      Therefore, modified-cleared/approved methods, which are standard methods used 
      outside their intended scope, are of interest. The aim of the present study was 
      to establish a model to validate modified-approved methods in agreement with the 
      College of American Pathologists (CAP) accreditation requirements. Methods 
       Concentrations of hCG in CSF were determined by means of 
      electrochemiluminescence immunoassay using a Roche Cobas e 602 immunoassay 
      analyzer. Based on the intended use, the following performance characteristics 
      were evaluated: precision, the limit of quantitation (LoQ), and the analytical 
      measurement range (AMR). The reference interval (RI) was also established. For 
      the clinical application study, CSF and serum hCG were measured in 10 patients 
      diagnosed with germinoma. Results  The intra- and inter-assay precisions at two 
      levels (10, 250 IU/L) were 0.64 and 0.57% and 4.26 and 3.54%, respectively. The 
      LoQ for hCG was determined to be 0.25 IU/L. The AMR was set from 0.2 to 1,200 
      IU/L. The RI for hCG in CSF was below 0.40 IU/L. The CSF hCG levels of 10 
      patients were all above 0.4 IU/L before therapy. Conclusion  Modified-approved 
      methods were validated and showed that the quality specifications of the medical 
      laboratory have a positive value in the clinical context. The illustration of 
      quantification of hCG in CSF resulted in compliance with the CAP accreditation 
      requirements.
CI  - The Indian Association of Laboratory Physicians. This is an open access article 
      published by Thieme under the terms of the Creative Commons 
      Attribution-NonDerivative-NonCommercial License, permitting copying and 
      reproduction so long as the original work is given appropriate credit. Contents 
      may not be used for commercial purposes, or adapted, remixed, transformed or 
      built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ).
FAU - Hu, Yao
AU  - Hu Y
AD  - Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, 
      Fudan University, Shanghai, China.
FAU - Ni, Jiajin
AU  - Ni J
AD  - Department of Nursing, Huashan Hospital, Shanghai Medical College, Fudan 
      University, Shanghai, China.
FAU - Zhang, Huating
AU  - Zhang H
AD  - Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, 
      Fudan University, Shanghai, China.
FAU - Wu, Wenqing
AU  - Wu W
AD  - Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, 
      Fudan University, Shanghai, China.
FAU - Chen, Yanwen
AU  - Chen Y
AD  - Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, 
      Fudan University, Shanghai, China.
FAU - Guan, Ming
AU  - Guan M
AD  - Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, 
      Fudan University, Shanghai, China.
LA  - eng
PT  - Journal Article
DEP - 20210908
PL  - Germany
TA  - J Lab Physicians
JT  - Journal of laboratory physicians
JID - 101551511
PMC - PMC9519259
OTO - NOTNLM
OT  - cerebral spinal fluid
OT  - human chorionic gonadotropin
OT  - method validation
COIS- Conflict of Interest None declared.
EDAT- 2022/10/04 06:00
MHDA- 2022/10/04 06:01
PMCR- 2021/09/01
CRDT- 2022/10/03 04:31
PHST- 2022/10/03 04:31 [entrez]
PHST- 2022/10/04 06:00 [pubmed]
PHST- 2022/10/04 06:01 [medline]
PHST- 2021/09/01 00:00 [pmc-release]
AID - 2120556 [pii]
AID - 10.1055/s-0041-1733817 [doi]
PST - epublish
SO  - J Lab Physicians. 2021 Sep 8;14(1):11-15. doi: 10.1055/s-0041-1733817. 
      eCollection 2022 Mar.