Analytical and clinical evaluation of a human chorionic gonadotrophin plus β (hCG + βhCG) immunoassay in germ cell tumours and gestational trophoblastic disease

Anckaert, Ellen; Elst, K. Ver; Mees, Marleen; Lecomte, Sophie; Bock, S. De; Schiettecatte, Johan; Smitz, Johan

doi:10.1016/j.immbio.2004.12.003

Cited by 3 publications

(5 citation statements)

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“…Moreover, the Centaur assay does appear to preferentially recognize free b hCG and not detect b-core hCG, making this particular immunoassay less than optimal for use in measuring hCG as a tumour marker. 14,20,28 In relation to laboratory provision, the National Academy of Clinical Biochemistry and the European Group on tumours markers guidelines emphasize that both intact hCG and its free b-subunit should be recognized by hCG assays used in oncology and that good baseline stability is essential for hCG because treatment may be instituted on the basis of relatively small increases in marker concentrations. 23 In our case, we reported three patients with germinoma properly established, so the diagnostic sensitivity of a concentration of hCG in CSF above the upper limit established in our laboratory is 100%.…”

Section: Discussionmentioning

confidence: 99%

“…The assay is calibrated against the Fourth International Standard for hCG from the National Institute for Biological Standards and Control, code 75/589. 20 The measuring range is 0.1-10,000 IU/L. According to the package insert, normal values for serum hCG are less than 2 IU/L for men and to 1 IU/L for premenopausal women.…”

Section: Design and Subjectsmentioning

confidence: 99%

“…The specific monoclonal antibodies used by the Elecsys assay measure intact hCG, free b-hCG, nicked forms, hCG missing the carboxyterminal peptide of the b-subunit and b-core hCG. 20 So, the antibodies are directed to an epitope present on intact hCG and the free b fraction, and therefore can detect the two separate entities, thus making it adequate for measuring hCG þ b in clinical practice. 22,23 Analytical validation of the mentioned method for application in CSF has been developed in two stages.…”

Section: Design and Subjectsmentioning

confidence: 99%

“…It is, therefore, important to select a hCG immunoassay method, which is able to measure the clinically relevant hCG variants for diagnosis and monitoring of germinal cell tumours. 20–22 In addition, to our knowledge, the existing immunoassays of the hormone have been validated mainly for application in serum, and few studies have been performed regarding the validation of such techniques in CSF. 14 Because matrix effects can influence test results when alternative sample types are used, CSF should be validated for the assay before clinical use.…”

Section: Introductionmentioning

confidence: 99%

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Validation of the human chorionic gonadotropin immunoassay in cerebrospinal fluid for the diagnostic work-up of neurohypophyseal germinomas

et al. 2011

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Background: The measurement of human chorionic gonadotropin (hCG) in cerebrospinal fluid (CSF) is useful for the differential diagnosis of suprasellar lesions. However, the concentrations that prove diagnostic for neurohypophyseal germinoma have not been well defined. In addition, the immunoassays used for such measurements are the same as those applied in serum, and few studies have been performed regarding the validation of such techniques in CSF. The present study aims to apply the Elecsys w hCG þ b immunoassay from Roche Diagnostics to measure hCG in CSF, as a useful tool in the diagnosis of neurohypophyseal germinomas in children and young adults. Methods: Validation of the immunoassay involved calculation of the functional sensitivity and reference values for hCG in CSF in 35 controls in the absence of pregnancy, trophoblastic disease or tumour pathology. For the clinical application study, three patients diagnosed with neurohypophyseal germinoma have been reviewed. Results: The functional sensitivity obtained was 0.4 IU/L. The reference values for hCG in CSF ranged from undetectable values to 0.7 IU/L. The hCG concentrations in CSF in the three studied patients, with confirmed diagnosis of neurohypophyseal germinoma, were 21.1, 32.6 and 23 IU/L, respectively. Conclusions: The Elecsysw hCG þ b immunoassay from Roche Diagnostics can be used to detect hCG in CSF with high precision. According to our results, CSF-hCG concentrations that exceed the established reference interval (undetectable values to 0.7 IU/L) in the presence of suprasellar lesions and hypophyseal stalk thickening must be considered pathological, establishing the need to exclude the presence of germinoma.

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Section: Discussionmentioning

confidence: 99%

Section: Design and Subjectsmentioning

confidence: 99%

Section: Design and Subjectsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Validation of the human chorionic gonadotropin immunoassay in cerebrospinal fluid for the diagnostic work-up of neurohypophyseal germinomas

et al. 2011

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“…Human chorionic gonadotrophin (HCG), a 37 kDa glycoprotein hormone [1], belongs to the family of heterodimeric glycoprotein hormones which share a common subunit and differ in the subunits that confer biologic and immunologic specificity [2]. HCG secreted by trophoblast cells of placenta and trophoblast cells in gestational trophoblastic diseases play an important role in early diagnosis of all pregnancy tests and trophoblastic diseases, such as choriocarcinoma, ectopic pregnancy and hydatidiform moles [3].…”

Section: Introductionmentioning

confidence: 99%

An Amperometric Immunosensor Based on Layer‐by‐Layer Assembly of L‐Cysteine and Nanosized Prussian Blue on Gold Electrode for Determination of Human Chorionic Gonadotrophin

et al. 2009

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A novel amperometric immunosensor based on l-cysteine/nanosized Prussian blue bilayer films ({NPB/l-cys} 2 ) and gold nanoparticles (nano-Au) was fabricated for determination of human chorionic gonadotrophin (HCG). First, l-cys and NPB was self-assembled by layer-by-layer (LBL) technology to form {NPB/l-cys} 2 bilayer films on the gold electrode. Subsequently, nano-Au layer was immobilized on the {NPB/l-cys} 2 bilayer films by electrodepositing gold chloride tetrahydrate and then anti-HCG was assembly on the nano-Au layer. Finally hemoglobin (Hb) was employed to block sites against nonspecific binding. With the electrocatalytic ability of Hb and NPB for the reduction of H 2 O 2 , the current signal of the antigen-antibody reaction was amplified and the enhanced sensitivity was achieved. In this study, the assembly process and performance of the immunosensor were characterized by cyclic voltammetry (CV) and the morphology was researched by scanning electron microscopy (SEM). The immunosensor performed a high sensitivity and a wide linear response to HCG in two ranges from 0.5 to 10 mIU/mL and from 10 to 200 mIU/mL with a relatively low detection limit of 0.2 mIU/mL at 3 times the background noise, as well as good stability and long-term life.

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A step forward in identifying the right human chorionic gonadotropin assay for testicular cancer

Ferraro

Panteghini

2019

Clinical Chemistry and Laboratory Medicine (CCLM)

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Clinical practice guidelines for the management of germ cell tumors recommend the measurements of human chorionic gonadotropin (hCG) and/or free hCGβ subunit for earlier diagnosis/recognition of the residual disease, for the prognostic evaluation and for the post-chemotherapy surveillance. However, the marketed hCG assays are validated and approved only for pregnancy purposes, with the sole exception of the Elecsys ‘hCG+β’ assay (Roche Diagnostics), cleared in Europe for oncological application. Theoretically, the hCG assay design for oncological purposes should fulfil the recommendations of the International Society of Oncology and Biomarkers requiring the use of antibodies displaying an equimolar recognition of both intact hCG and hCGβ monomer. Further analytical requirements should also be considered, such as optimal analytical sensitivity to allow an early tumor detection and low cross-reactivity for luteinizing hormone (LH). For the Elecsys assay, the detection limit (0.2 U/L) and the reported cross-reactivity for LH (0.12%) may be considered adequate if compared with the recommended requirements. Another issue is the definition of decision limits for oncologic purposes. After 3 years of clinical experience using the Elecsys assay in the oncology setting, we were able to define limits partitioned by sex and age as follows: males <50 years, 0.3 U/L; males >50 years, 2.3 U/L; female <50 years, 2.1 U/L; female >50 years, 5.6 U/L. There is an urgent need to disseminate appropriate educational information and to boost the clinical use of selective, highly sensitive and precise assays, specifically manufactured for cancer application.

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Analytical and clinical evaluation of a human chorionic gonadotrophin plus β (hCG + βhCG) immunoassay in germ cell tumours and gestational trophoblastic disease

Cited by 3 publications

References 4 publications

Validation of the human chorionic gonadotropin immunoassay in cerebrospinal fluid for the diagnostic work-up of neurohypophyseal germinomas

Validation of the human chorionic gonadotropin immunoassay in cerebrospinal fluid for the diagnostic work-up of neurohypophyseal germinomas

An Amperometric Immunosensor Based on Layer‐by‐Layer Assembly of L‐Cysteine and Nanosized Prussian Blue on Gold Electrode for Determination of Human Chorionic Gonadotrophin

A step forward in identifying the right human chorionic gonadotropin assay for testicular cancer

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