An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: Validation of a Modified-Approved Method for Accreditation by the College of American Pathologists
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...
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| Format: | Article |
| Language: | English |
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Thieme Medical and Scientific Publishers Pvt. Ltd.
2022-03-01
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| Series: | Journal of Laboratory Physicians |
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| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0041-1733817 |
| _version_ | 1811265348193746944 |
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| author | Yao Hu Jiajin Ni Huating Zhang Wenqing Wu Yanwen Chen Ming Guan |
| author_facet | Yao Hu Jiajin Ni Huating Zhang Wenqing Wu Yanwen Chen Ming Guan |
| author_sort | Yao Hu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-12T20:22:05Z |
| format | Article |
| id | doaj.art-e0e0bdb224924193a7a0a8abb3427a76 |
| institution | Directory Open Access Journal |
| issn | 0974-2727 0974-7826 |
| language | English |
| last_indexed | 2024-04-12T20:22:05Z |
| publishDate | 2022-03-01 |
| publisher | Thieme Medical and Scientific Publishers Pvt. Ltd. |
| record_format | Article |
| series | Journal of Laboratory Physicians |
| spelling | doaj.art-e0e0bdb224924193a7a0a8abb3427a762022-12-22T03:17:59ZengThieme Medical and Scientific Publishers Pvt. Ltd.Journal of Laboratory Physicians0974-27270974-78262022-03-01140101101510.1055/s-0041-1733817An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: Validation of a Modified-Approved Method for Accreditation by the College of American PathologistsYao Hu0Jiajin Ni1Huating Zhang2Wenqing Wu3Yanwen Chen4Ming Guan5Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.Department of Nursing, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.Department of Laboratory Medicine, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.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.http://www.thieme-connect.de/DOI/DOI?10.1055/s-0041-1733817human chorionic gonadotropincerebral spinal fluidmethod validation |
| spellingShingle | Yao Hu Jiajin Ni Huating Zhang Wenqing Wu Yanwen Chen Ming Guan An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: Validation of a Modified-Approved Method for Accreditation by the College of American Pathologists Journal of Laboratory Physicians human chorionic gonadotropin cerebral spinal fluid method validation |
| title | An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: Validation of a Modified-Approved Method for Accreditation by the College of American Pathologists |
| title_full | An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: Validation of a Modified-Approved Method for Accreditation by the College of American Pathologists |
| title_fullStr | An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: Validation of a Modified-Approved Method for Accreditation by the College of American Pathologists |
| title_full_unstemmed | An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: Validation of a Modified-Approved Method for Accreditation by the College of American Pathologists |
| title_short | An Immunoassay for Human Chorionic Gonadotropin in Cerebrospinal Fluid: Validation of a Modified-Approved Method for Accreditation by the College of American Pathologists |
| title_sort | immunoassay for human chorionic gonadotropin in cerebrospinal fluid validation of a modified approved method for accreditation by the college of american pathologists |
| topic | human chorionic gonadotropin cerebral spinal fluid method validation |
| url | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0041-1733817 |
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