scholarly journals Utility of Commonly Used Commercial Human Chorionic Gonadotropin Immunoassays in the Diagnosis and Management of Trophoblastic Diseases

2001 ◽  
Vol 47 (2) ◽  
pp. 308-315 ◽  
Author(s):  
Laurence A Cole ◽  
Shohreh Shahabi ◽  
Stephen A Butler ◽  
Hugh Mitchell ◽  
Edward S Newlands ◽  
...  
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
False Positive ◽  
False Negative ◽  
Β Subunit ◽  
Serum Samples ◽  
Diagnosis And Management ◽  
Trophoblastic Diseases ◽  
Positive Results ◽  
Hcg Test

Abstract Background: Patients with trophoblastic diseases produce ordinary and irregular forms of human chorionic gonadotropin (hCG; e.g., nicked hCG, hCG missing the β-subunit C-terminal segment, hyperglycosylated hCG, and free β subunit) that are recognized to differing extents by automated immunometric hCG (or hCGβ) assays. This has led to low or false-negative results and misdiagnosis of persistent disease. False-positive hCG immunoreactivity has also been detected, leading to needless therapy for trophoblastic diseases. Here we compare seven commonly used hCG assays. Methods: Standards for five irregular forms hCG produced in trophoblastic diseases, serum samples from 59 patients with confirmed trophoblastic diseases, and serum samples from 12 women with previous false-positive hCG results (primarily in the Abbott AxSYM assay) were blindly tested by commercial laboratories in the Beckman Access hCGβ, the Abbott AxSYM hCGβ, the Chiron ACS:180 hCGβ, the Baxter Stratus hCG test, the DPC Immulite hCG test, the Serono MAIAclone hCGβ tests, and in the hCGβ RIA. Results: Only the RIA and the DPC appropriately detected the five irregular hCG standards. Only the Beckman, DPC, and Abbott assays gave results similar to the RIA in the patients with confirmed trophoblastic diseases (values within 25% of RIA in 49, 49, and 54 of 59 patients, respectively). For samples that were previously found to produce false-positive hCG results, no false-positive results were detected with the DPC and Chiron tests (5 samples, median <2 IU/L), but up to one-third of samples were false positive (>10 IU/L) in the Beckman (1 of 5), Serono (2 of 9), and Baxter assays (1 of 5), and the hCGβ RIA (3 of 9; median for all assays, <5 IU/L). These samples, which produced false-positive results earlier in the Abbott AxSYM assay, continued to produce high values upon reassessment (median, 81 IU/L). Conclusions: Of six frequently used hCG immunometric assays, only the DPC detected the five irregular forms of βhCG, agreed with the RIA, and avoided false-positive results in the samples tested. This assay, and similarly designed assays not tested here, seem appropriate for hCG testing in the diagnosis and management of trophoblastic diseases.

Effect of peptide nicking in the human chorionic gonadotropin β-subunit on stimulation of recombinant human thyroid-stimulating hormone receptors

1994 ◽  
Vol 130 (1) ◽  
pp. 92-96 ◽  
Author(s):  
Masayoshi Yoshimura ◽  
A Eugene Pekary ◽  
Xuan-Ping Pang ◽  
Loretta Berg ◽  
Laurence A Cole ◽  
...  
Keyword(s):  
Los Angeles ◽  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Hormone Receptors ◽  
Thyroid Stimulating Hormone ◽  
Human Thyroid ◽  
Β Subunit ◽  
Trophoblastic Diseases ◽  
Thyrotropic Activity ◽  
Stimulating Hormone

Yoshimura M, Pekary AE, Pang X-P, Berg L, Cole LA, Kardana A, Hershman JM. Effect of peptide nicking in the human chorionic gonadotropin β-subunit on stimulation of recombinant human thyroid-stimulating hormone receptors. Eur J Endocrinol 1994;130:92–6. ISSN 0804–4643 It is now generally accepted that human chorionic gonadotropin (hCG) has thyroid-stimulating activity. Heterologous forms of the hCG molecule occur in the purified preparations extracted from urine of pregnant women and patients with trophoblastic diseases. This work was undertaken to determine the effect of peptide nicking in the hCG-β subunit on its thyrotropic potency. Using Chinese hamster ovary cells expressing functional human thyroid-stimulating hormone (TSH) receptors, we examined the effect of nicked hCG on cyclic AMP (cAMP) production and receptor binding. The effect of human leukocyte elastase (hLE), a nicking enzyme, on standard hCG also was examined in the cAMP assay and on receptor binding. We studied five hCG preparations extracted from the urine of normal pregnancy (CR-127 and P8) and trophoblastic diseases (C2, C5 and M4). Two preparations (C2, 96% nicked and M4, 100% nicked in the β44–49 region) showed about a 1.5-fold potency of standard hCG CR-127, which is also 20% nicked in the same region. Non-nicked hCG (P8) had the weakest potency among all of the samples tested. Treatment of standard hCG with hLE increased the cAMP response about two-fold. Dose-dependent displacement of bovine [125I]TSH by standard hCG and hLE-digested hCG was observed and was almost identical. We have confirmed the increased in vitro thyrotropic activity of hCG nicked in the β-intercysteine loop on recombinant human TSH receptors. These data suggest that peptide heterogeneity of the hCG molecule may modulate the in vivo thyrotropic activity of hCG in pregnant women and patients with trophoblastic diseases. Jerome M Hershman, Endocrinology-W111D, West Los Angeles VA Medical Center, Los Angeles, California 90073, USA

scholarly journals Free β-Subunit of Human Chorionic Gonadotropin in Serum Is a Diagnostically Sensitive Marker of Seminomatous Testicular Cancer

2008 ◽  
Vol 54 (11) ◽  
pp. 1840-1843 ◽  
Author(s):  
Anna Lempiäinen ◽  
Ulf-Håkan Stenman ◽  
Carl Blomqvist ◽  
Kristina Hotakainen
Keyword(s):  
Testicular Cancer ◽  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Reference Intervals ◽  
Β Subunit ◽  
Serum Samples ◽  
Additional Information ◽  
Sensitive Marker

Abstract Background: We studied whether measurement of the free β subunit of human chorionic gonadotropin (hCGβ) in serum offers additional diagnostic information compared to determination of intact hCG alone in testicular cancer. Methods: We determined hCG and hCGβ with ultrasensitive assays in 94 serum samples obtained preoperatively, 22 samples obtained during relapse, and 3687 samples obtained during routine follow-up of 351 patients with testicular tumors. Results: In preoperative samples, isolated increases of hCGβ were seen in 40% of the samples from seminoma patients (n = 42) and in 8% of those from patients with nonseminomatous testicular cancer (NSGCT) (n = 51). Both markers were increased in 12% of the seminoma and 71% of the NSGCT patients and were within reference intervals in 43% of the seminoma and 20% of the NSGCT patients. Specific determination of hCGβ increased the frequency of marker-positive seminomas from 17% to 57% and of marker-positive relapses from 32% to 59% (n = 22). Theoretically, about 40% of marker-positive seminomas and relapses would have been missed with an assay measuring hCG and hCGβ together. Preoperative hCG and hCGβ concentrations correlated with stage, tumor histology, and disease-related mortality. Additionally, hCGβ correlated with tumor size. Conclusions: hCGβ is a diagnostically sensitive marker for testicular cancer. In patients with seminomatous testicular cancer, hCGβ is superior to hCG, and in some NSGCT patients it provides additional information.

scholarly journals False-Negative Results in Point-of-Care Qualitative Human Chorionic Gonadotropin (hCG) Devices Due to Excess hCGβ Core Fragment

2009 ◽  
Vol 55 (7) ◽  
pp. 1389-1394 ◽  
Author(s):  
Ann M Gronowski ◽  
Mark Cervinski ◽  
Ulf-Håkan Stenman ◽  
Alison Woodworth ◽  
Lori Ashby ◽  
...  
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Point Of Care ◽  
False Negative ◽  
The Core ◽  
Core Fragment ◽  
Negative Results ◽  
False Negative Results ◽  
Positive Results ◽  
Urine Specimens

Abstract Background: During pregnancy, human chorionic gonadotropin (hCG) immunoreactivity in urine consists of intact hCG as well as a number of hCG variants including the core fragment of hCGβ (hCGβcf). We identified 3 urine specimens with apparent false-negative results using the OSOM® hCG Combo Test (Genzyme Diagnostics) qualitative hCG device and sought to determine whether an excess of 1 of the fragments or variants might be the cause of the interference. Methods: We measured concentrations of hCG variants in the urine from 3 patients with apparent false-negative hCG results. Purified hCG variants were added to urines positive for hCG and tested using the OSOM, ICON® 25 hCG (Beckman Coulter), and hCG Combo SP® Brand (Cardinal Health) devices. Results: Dilution of these 3 urine samples resulted in positive results on the OSOM device. Quantification of hCG variants in each of the 3 patient urine specimens demonstrated that hCGβcf occurred in molar excess of intact hCG. Addition of purified hCGβcf to hCG-positive urines caused false-negative hCG results using the OSOM and ICON qualitative urine hCG devices. Conclusions: Increased concentrations of hCGβcf can cause false-negative results on the OSOM and ICON qualitative urine hCG devices. .

scholarly journals Žmogaus chorioninio gonadotropino reikšmė klinikinėje praktikoje

2013 ◽  
Vol 12 (4) ◽  
pp. 238-242
Author(s):  
Oldas Tamašauskas ◽  
Ieva Šiaudinytė
Keyword(s):  
Ectopic Pregnancy ◽  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
False Positive ◽  
Clinical Status ◽  
Test Results ◽  
Laboratory Equipment ◽  
Heterophilic Antibodies ◽  
Diagnostic Approaches ◽  
Positive Results

Žmogaus chorioninio gonadotropino (hCG) koncentracijos nustatymas dažniausiai naudojamas ankstyvo nėštumo diagnostikai, trukmei nustatyti bei nėštumui stebėti. Be to, HCG yra vertingas diagnozuojant savaiminį persileidimą, nesivystantį arektopinį nėštumą. Šis hormonas leidžia prenataliai įvertinti vaisiaus apsigimimų riziką. Taip pat hCG labai svarbus trofoblastinių ligų ir tam tikrų lokalizacijų vėžio diagnostikai, gydymo efektyvumo vertinimui. Retai, tačiau galimi ir klaidingai teigiamityrimų rezultatai dėl analitinių klaidų, tyrimams naudojamų įrenginių, prietaisų gedimų ar tam tikrų kraujyje esančių medžiagų (pvz.: heterofiliniai antikūnai, autoantikūnai, reumatoidinis faktorius, taip pat bilirubinas, hemoglobinas ar lipidai galilemti klaidingus, netikslius tyrimo rezultatus), todėl svarbu įvertinti ne vieno tyrimo rezultatus, o bendrą klinikinį vaizdą, visą surinktą informaciją ir apsvarstyti visas klinikinės diagnozės galimybes.Reikšminiai žodžiai: žmogaus chorioninis gonadotropinas, hCG, ektopinis nėštumas, klaidingai teigiamas rezultatas, Immulite2000, nėštumo diagnostika.The significance of human chorionic gonadotropin in clinical practice pregnancy, assess its duration and observe its course. In addition, hCG is a valuable tool in the diagnostics of miscarriage, nondeveloping foetus or ectopic pregnancy. The measurements of this hormone allow to suspect the possible risk of foetalabnormalities. hCG is also used to diagnose and follow the course of particular types of cancer and diseases of throphoblastic origin. Rarely, though, it is possible that false positive results ensue due to failures of analysis, malfunction of laboratory equipment or particular substances circulating in the blood, i.e. heterophilic antibodies, autoantibodies, the rheumatoid factor, bilirubin, haemoglobin or lipids could possibly lead to false test results. Taking into consideration all the previously mentionedissues, it is always important to assess the whole clinical status of the patient, to gather all the possible information and to consider various diagnostic approaches and not to rely too heavily on one laboratory test.Key words: human chorionic gonadotropin, ectopic pregnancy, hCG, false-positive rezult, Immulite2000, pregnancy diagnostics

Four rapid serum-urine combination assays of choriogonadotropin (hCG) compared and assessed for their utility in quantitative determinations of hCG

1994 ◽  
Vol 40 (10) ◽  
pp. 1944-1949 ◽  
Author(s):  
S H Mishalani ◽  
J Seliktar ◽  
G D Braunstein
Keyword(s):  
False Positive ◽  
The Other ◽  
Urine Samples ◽  
Serum Samples ◽  
Positive Urine ◽  
Sample Application ◽  
Positive Results ◽  
Hcg Test ◽  
In Pregnancy

Abstract We evaluated the performance of four visually read pregnancy tests (TestPack Plus hCG Combo, ICON II hCG, SureCell hCG-Serum/Urine and PregnaGen 1-Step) designed to detect increased concentrations of choriogonadotropin (hCG) in either serum or urine samples. The biochemical sensitivities and specificity in both serum and urine samples were similar for each kit. All kits correctly identified pregnancy serum samples: The TestPack Plus hCG Combo and SureCell hCG-Serum/Urine were 100% specific; the other two kits exhibited a few false-positive results. For urine samples the ICON II hCG test was 100% sensitive, and the other three were 99.5% sensitive, with false-positive urine results occasionally reported by the PregnaGen 1-Step and ICON II hCG tests. Quantitative hCG concentrations could be estimated in pregnancy serum samples, but not urine samples, through determination of the time elapsed from the sample application or addition of the final reagent to the first appearance of a positive result.

scholarly journals Human Chorionic Gonadotropin Assays for Testicular Tumors: Closing the Gap between Clinical and Laboratory Practice

2018 ◽  
Vol 64 (2) ◽  
pp. 270-278 ◽  
Author(s):  
Simona Ferraro ◽  
Chiara Trevisiol ◽  
Massimo Gion ◽  
Mauro Panteghini
Keyword(s):  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Clinical Evidence ◽  
False Negative ◽  
Germ Cell Tumors ◽  
Tumor Stage ◽  
Testicular Germ Cell ◽  
Closing The Gap ◽  
Positive Results

Abstract BACKGROUND Clinical practice guidelines recommend the measurement of human chorionic gonadotropin (hCG) and/or hCGβ in serum for management of testicular germ cell tumors (GCTs). These guidelines, however, disregard relevant biochemical information on hCG variants to be detected for oncological application. We set out to provide a critical review of the clinical evidence together with a characterization of the selectivity of currently marketed hCG immunoassays, identifying assays suitable for management of GCTs. CONTENT Evidence sources in the available literature were critically appraised. Most instances of misdiagnosis and mismanagement of testicular GCTs have been associated with hCG results. According to the clinical evidence, 36% of patients with seminoma show an exclusive hCGβ increase, and 71% of patients with nonseminomatous GCTs (NSGCTs) show an increase of intact hCG and/or hCG + hCGβ, whereas the hCGβ increase in NSGCTs is variable according to the tumor stage and histology. SUMMARY hCG + hCGβ assays that display an equimolar recognition of hCG and hCGβ, or at least do not overtly underestimate hCGβ, may be employed for management of testicular GCTs. Assays that underestimate hCGβ are not recommended for oncological application. In addition to the hCG + hCGβ assay in service, an additional assay with broader selectivity for other hCG variants should be considered when false-negative or false-positive results are suspected on the basis of clinical data.

scholarly journals Evaluation of Serum Cryptococcal Antigen Testing Using Two Novel Semiquantitative Lateral Flow Assays in Persons with Cryptococcal Antigenemia

2020 ◽  
Vol 58 (4) ◽  
Author(s):  
Caleb Skipper ◽  
Kiiza Tadeo ◽  
Emily Martyn ◽  
Elizabeth Nalintya ◽  
Radha Rajasingham ◽  
...  
Keyword(s):  
False Positive ◽  
Diagnostic Performance ◽  
False Negative ◽  
Lateral Flow ◽  
Reference Standard ◽  
Serum Samples ◽  
Cryptococcal Antigen ◽  
Negative Results ◽  
Lateral Flow Assays ◽  
Positive Results

ABSTRACT Early cryptococcal disease can be detected via circulating antigen in blood before fulminant meningitis develops, when early antifungal therapy improves survival. Two semiquantitative cryptococcal antigen (CrAg) lateral flow assays (LFAs) have been developed, but their diagnostic performance has not been defined. Cryopreserved serum samples from HIV-infected Ugandans obtained as part of a prospective CrAg-screening cohort were tested in duplicate for CrAg by the CrAgSQ (IMMY) and CryptoPS (Biosynex) lateral flow assays. Case-controlled diagnostic performance was measured using the FDA-approved CrAg LFA (IMMY) as a reference standard via McNemar’s test. Of 99 serum samples tested, 57 were CrAg positive (CrAg+) by the CrAg LFA reference standard. By CrAgSQ, 57 were read as positive, with 98% sensitivity (56/57; 95% confidence interval [CI], 0.91 to 0.99) and 98% specificity (41/42; 95% CI, 0.88 to 0.99) (McNemar’s, P = 0.99). The sample with a false-negative result by CrAgSQ (n = 1) had a titer of <1:5, while the sample with a false-positive result (n = 1) yielded a 1+ result. By CryptoPS, 52 samples were read as positive, with 88% sensitivity (50/57; 95% CI, 0.76 to 0.95) and 95% specificity (40/42; 95% CI, 0.84 to 0.99) (McNemar’s, P = 0.18). The CryptoPS false-negative results included samples with titers of <1:5 (n = 1), 1:5 (n = 5), and 1:20 (n = 1), while samples with false-positive results by CryptoPS (n = 2) yielded Positive results. The CryptoPS assay missed 35% (7/20) of samples with CrAg LFA titers of ≤1:20. The new semiquantitative CrAg LFAs allow rapid estimation of titer levels in easy-to-perform platforms. The CrAgSQ demonstrated better qualitative sensitivity and specificity than the CryptoPS compared to the reference standard. The exact grading of the CrAgSQ results has some subjectivity, with interreader variability; however, qualitative reads were generally concordant for both assays.

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