hCG Assays Research Articles

Target-mediated silver deposition-based electrochemical biosensor for highly sensitive detection of human chorionic gonadotropin

As a glycoprotein hormone, human chorionic gonadotropin (hCG) is an established marker for pregnancy test. On the basis of the target-mediated silver deposition (TSD), in this work, we report the development of an amplification-free electrochemical biosensor for the highly sensitive detection of hCG. The detection of hCG involves the use of the affinity peptide-modified electrode for hCG capture (the CGGSSPPLRINRHILTR peptide containing the hCG-binding domain of the PPLRINRHILTR sequence is used as the affinity peptide), the oxidation of the diol sites of the glycan chains on hCG hormones into aldehyde groups by NaIO4, and the deposition of silver nanoparticles (AgNPs) for the solid-state voltammetric stripping analysis. Due to the deposition of multiple AgNPs while the solid-state Ag/AgCl voltammetric process has a high signal-to-noise ratio, the TSD-based electrochemical biosensor can be applied to the highly sensitive detection of hCG without the need for signal amplification. Under optimal conditions, the stripping current increased linearly with an increasing hCG concentration over the range from 1.0 to 25 mIU/mL, with a detection limit of 0.45 mIU/mL. Owing to the high specificity of the hCG-binding peptide PPLRINRHILTR, this electrochemical hCG biosensor exhibits high selectivity. The results of the quantitative assay of hCG in urine samples at the concentrations of 25, 10, and 1.0 mIU/mL are desirable, indicating the good anti-interference capability. As the TSD-based electrochemical biosensor allows the amplification-free detection of low-abundance hCG, it is easy to use and cost-effective, showing great promise in point-of-care assay of hCG for pregnancy test.

Detection of the GH analog somatrogon in sports drug testing: Immunological approaches and LC-HRMS/MS.

Due to the presumed lipolytic and anabolic properties, the misuse of human growth hormone (hGH) and its synthetic analogs in sports is prohibited both in- and out-of-competition. Within this research project, the detectability of somatrogon, a recombinant fusion glycoprotein of 22 kDa hGH and the C-terminal peptide (CTP) of the human chorionic gonadotropin (hCG) β-subunit, with current WADA-approved doping control assays for hGH and hCG was investigated. For that purpose, cross-reactivity tests and a somatrogon administration study were conducted, and only "Kit 2" of the GH isoform differential immunoassays proved applicable to the detection of somatrogon administration in serum. In urine, the immunoassay specific for total hCG yielded presumptively positive findings for several post-administration samples, which can probably be attributed to the presence of an immunoreactive fragment of the hCG β-subunit. As the detectability of somatrogon with these approaches was found to be limited, a highly specific detection assay (LOD: 10ng/mL) for the drug in serum samples was developed by using affinity purification with GH receptor (GHR)-conjugated magnetic beads, proteolytic digestion, and liquid chromatography high-resolution tandem mass spectrometry (LC-HRMS/MS). Following optimization, the approach was comprehensively characterized, and authentic post-administration serum samples were successfully analyzed as proof-of-concept, indicating a detection window of at least 96 h. Consequently, the presented method can be employed to confirm the presence of somatrogon in serum samples, where only "Kit 2" of the currently used immunoassay kits yielded an abnormally high Rec/Pit ratio.

P-286 Comparative study of frozen-thawed embryo transfer with modified natural cycle versus HRT cycle in previously cancelled true natural cycle patients

Abstract Study question Is there any difference in outcome of frozen embryo transfer(FET) between hormone replacement therapy(HRT) and modified natural cycle(MNC) in previously cancelled true natural cycle patients Summary answer In patients with previous history of cancelled true natural cycle, MNC results in higher clinical pregnancy rates after FET, when compared to HRT cycle What is known already Preparation of endometrium lays down the foundation for conception and subsequent successful pregnancy.There has been a plethora of endometrial preparation protocols described in the literature. The established protocols are true natural cycle,MNC with or without luteal phase support(LPS) and HRT cycle with or without gonadotrophin releasing hormone agonist(GnRha) suppression. Nevertheless,there is no consensus on protocol which may provide the best outcome in patients who have had cancelled true natural cycle.In such situations,HRT cycle may be considered as an easy option as the cancellation rate is low.However,HRT treatment is known for higher early pregnancy and obstetric complications,compared to MNC Study design, size, duration Prospective observational study,where 155 patients undergoing FET who had minimum one true natural cycle cancellation were recruited.They were divided into group A undergoing HRT cycle(n = 77) and group B for MNC cycle(n = 78).The study was conducted in a fertility unit over six months from June-November 2023.Primary outcome measures were serum betaHCG estimation and ultrasonographic documentation of intrauterine pregnancy.Results were analysed using statistical software SPSS version25 and p value of less than 0.05 was considered statistically significant Participants/materials, setting, methods HRT patients received injectable GnRha 3.75 mg on day21 of previous cycle.Oral estradiol valerate 6mg daily started on day2 of menses. When ET was minimum 7mm, luteal phase support(LPS) was started with daily oral and vaginal progesterone(30mg and 600mcg respectively),followed by FET. MNC patients received Letrozole 5mg daily from day 2-6 of menstruation.rhCG 250mcg was given subcutaneously,when ET was at least 7mm,dominant follicle 16-18mm and progesterone(P4) less than 1ng/ml.LPS(vaginal progesterone600mcg) was started 36hours after rHCG,followed by FET Main results and the role of chance Mean ET in MNC group was 8.92mm ± SD1.38, which was higher than HRT group (8.31 mm ± SD0.89). This difference was statistically significant with a p value of 0.014.Serum beta HCG estimation was done 2weeks after FET. In HRT group beta HCG was positive in 41 out of 77(53.25%) and in MNC group positivity was higher being 48 out of 78(61.54%). However, this difference was not statistically significant. Transvaginal ultrasonography(TVS) was done to confirm intrauterine pregnancy 2weeks after beta HCG assay. Clinical pregnancy rate(CPR) was higher in MNC group with 32 out of 78(41.03%),compared to 18 out of 77(23.38%) in HRT group. This difference is statistically significant with p value of 0.019 Limitations, reasons for caution Relatively small population in this study may be the reason for caution to interpret the statistical data. Study with higher numbers may bring about more robust conclusions Wider implications of the findings Patients with failed true natural cycles may be considered for modified natural cycle(MNC) stimulation for FET, without attempt of another true natural cycle stimulation Trial registration number NOT APPLICABLE

B-040 Performance Evaluation of Five Reproductive Endocrinology Assays on the Atellica CI 1900 Analyzer

Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer utilizing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica IM Luteinizing Hormone (LH), Progesterone (PRGE), Follicle Stimulating Hormone (FSH), Prolactin (PRL), and Total hCG (ThCG) assays* on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 LH, PRGE, FSH, PRL, and ThCG assays use the same reagents and calibrators as the comparable Atellica IM assays. Precision and method comparison (MC) studies were used as performance indicators for the Atellica CI 1900 Analyzer. Precision studies were performed according to CLSI EP05-A3 using quality control material and native and contrived human serum samples. One aliquot of each sample pool was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥20 days with one reagent lot on two systems. MC studies were performed according to CLSI EP09-A3. Individual native human serum samples were analyzed using the Atellica IM assays on both the Atellica IM and Atellica CI 1900 Analyzers. Results Representative precision and MC results are listed for each assay in the table. Over the five assays tested, repeatability and within-lab %CVs were <7% and <13.5%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica IM LH, PRGE, FSH, PRL, and ThCG assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica IM Analyzer. *The products/features mentioned here are not commercially available in all countries. Their future availability cannot be guaranteed.

Measurement of Human Chorionic Gonadotrophin in Women with Gestational Trophoblastic Disease

Objectives: The objective of this study was to collect information on human chorionic gonadotrophin (hCG) laboratory testing and reporting in women with gestational trophoblastic disease (GTD), to assess the associated challenges, and to offer perspectives on hCG testing harmonisation. Design: Information was collected from laboratories by electronic survey (SurveyMonkey) using a questionnaire designed by members of the European Organisation for the Treatment of Trophoblastic Disease (EOTTD) hCG working party. Participants: The questionnaire was distributed by the EOTTD board to member laboratories and their associated scientists who work within the GTD field. Setting: The questionnaire was distributed and accessed via an online platform. Methods: The questionnaire consisted of 5 main sections. These included methods used for hCG testing, quality procedures, reporting of results, laboratory operational aspects, and non-GTD testing capability. In addition to reporting these survey results, examples of case scenarios which illustrate the difficulties faced by laboratories providing hCG measurement for GTD patient management were described. The benefits and challenges of using centralised versus non-centralised hCG testing were discussed alongside the utilisation of regression curves for management of GTD patients. Results: Information from the survey was collated and presented for each section and showed huge variability in responses across laboratories even for those using the same hCG testing platforms. An educational example was presented, highlighting the consequence of using inappropriate hCG assays on clinical patient management (Educational Example A), along with an example of biotin interference (Educational Example B) and an example of high-dose hook effect (Educational Example C), demonstrating the importance of knowing the limitations of hCG tests. The merits of centralised versus non-centralised hCG testing and use of hCG regression curves to aid patient management were discussed. Limitations: To ensure the survey was completed by laboratories providing hCG testing for GTD management, the questionnaire was distributed by the EOTTD board. It was assumed the EOTTD board held the correct laboratory contact, and that the questionnaire was completed by a scientist with in-depth knowledge of laboratory procedures. Conclusions: The hCG survey highlighted a lack of harmonisation of hCG testing across laboratories. Healthcare professionals involved in the management of women with GTD should be aware of this limitation. Further work is needed to ensure an appropriate, quality-assured laboratory service is available for hCG monitoring in women with GTD.

Persistently elevated serum concentrations of human chorionic gonadotropin (hCG).

We describe a woman with constantly elevated hCG levels in serum. Since assay interference, pregnancy or cancer did not explain the elevated levels, we measured the concentrations of hCG, its β subunit (hCGβ) and its core fragment (hCGβcf) in serum and urine using specific assays, to understand the nature of the elevated hCG levels. We used 3 assays for total hCG (these assays also recognize hCGβ and to various degrees hCGβcf), 3 for intact hCG heterodimer, 3 for free hCGβ and one for hCGβcf. With an hCG assay detecting total hCG the serum concentrations were in the range of 150-260 IU/L for the whole study period of almost 5 years, except for a peak of 1,200 IU/L, coinciding with a spontaneous abortion. Quantitation of different forms of hCG with specific immunoassays showed that the immunoreactivity in serum consisted of hCGβ. Urine contained hCGβ and hCGβcf. The laboratory findings are in keeping with familial hCG syndrome. However, so far the condition remains to be determined in any family members. Elevated hCG levels without any explanation are problematic as they cause suspicion of cancer or ectopic pregnancy and may lead to harmful therapy. Specific assays, as used here, will aid in diagnosis of such cases.

Limitations of the Human Chorionic Gonadotropin (hCG) Assay in the Diagnosis of Gestational Trophoblastic Disease

A 31-year-old lady presented with abnormal vaginal bleeding during her first trimester of pregnancy. Based on the ultrasound findings and the decreasing hCG trend (from 1040 mIU/mL to 759 mIU/mL), a diagnosis of missed miscarriage was made. A week later, the patient presented with heavy vaginal bleeding. Ultrasound findings showed classic snowstorm appearance suggestive of complete hydatidiform mole. The serum hCG level however, was 357 mIU/mL. In a case of hydatiform mole with inappropriately low hCG, analytical interference was suspected. Post- dilution serum hCG of 5,775,000 mIU/mL confirmed the presence of hook effect in a two-site hCG immunoassay. Discordance between serum hCG and clinical findings should be actively investigated by the laboratory to prevent delay in diagnosis and treatment. This case also highlights the need for clinicians to be aware of the hCG assay used in their hospital’s laboratory so that they may recognise false negative hCG results.

Limitations of the Human Chorionic Gonadotropin (hCG) Assay in the Diagnosis of Gestational Trophoblastic Disease

A 31-year-old lady presented with abnormal vaginal bleeding during her first trimester of pregnancy. Based on the ultrasound findings and the decreasing hCG trend (from 1040 mIU/mL to 759 mIU/mL), a diagnosis of missed miscarriage was made. A week later, the patient presented with heavy vaginal bleeding. Ultrasound findings showed classic snowstorm appearance suggestive of complete hydatidiform mole. The serum hCG level however, was 357 mIU/mL. In a case of hydatiform mole with inappropriately low hCG, analytical interference was suspected. Post- dilution serum hCG of 5,775,000 mIU/mL confirmed the presence of hook effect in a two-site hCG immunoassay. Discordance between serum hCG and clinical findings should be actively investigated by the laboratory to prevent delay in diagnosis and treatment. This case also highlights the need for clinicians to be aware of the hCG assay used in their hospital’s laboratory so that they may recognise false negative hCG results.

A Customized Microfluidic Paper-Based Platform for Colorimetric Immunosensing: Demonstrated via hCG Assay for Pregnancy Test

Over the past decades, paper-based lateral flow immunoassays (LFIAs) have been extensively developed for rapid, facile, and low-cost detection of a wide array of target analytes in a point-of-care manner. Conventional home pregnancy tests are the most significant example of LFAs, which detect elevated concentrations of human chorionic gonadotrophin (hCG) in body fluids to identify early pregnancy. In this work, we have upgraded these platforms to a higher version by developing a customized microfluidic paper-based analytical device (μPAD), as the new generation of paper-based point-of-care platforms, for colorimetric immunosensing. This will offer a cost-efficient and environmentally friendly alternative platform for paper-based immunosensing, eliminating the need for nitrocellulose (NC) membrane as the substrate material. The performance of the developed platform is demonstrated by detection of hCG (as a model case) in urine samples and subsequently indicating positive or negative pregnancy. A dual-functional silane-based composite was used to treat filter paper in order to enhance the colorimetric signal intensity in the detection zones of μPADs. In addition, microfluidic pathways were designed in a manner to provide the desired regulated fluid flow, generating sufficient incubation time (delays) at the designated detection zones, and consequently enhancing the obtained signal intensity. The presented approaches allow to overcome the existing limitations of μPADs in immunosensing and will broaden their applicability to a wider range of assays. Although, the application of the developed hCG μPAD assay is mainly in qualitative (i.e., positive or negative) detection of pregnancy, the semi-quantitative measurement of hCG was also investigated, indicating the viability of this assay for sensitive detection of the target hCG analyte within the related physiological range (i.e., 10–500 ng/mL) with a LOD value down to 10 ng/mL.

P–587 Highly purified human menopausal gonadotrophin (HP-hMG, Menopur) as a ready-to-use solution for injection in pre-filled pen is bioequivalent to HP-hMG powder for reconstitution

Abstract Study question Are serum FSH levels after single subcutaneous dosing of HP-hMG in a liquid formulation and a powder formulation bioequivalent? Summary answer The 90% CIs for the geometric mean ratios of serum FSH AUCt and Cmax were both within 0.8000–1.2500, thus the two formulations are bioequivalent. What is known already For several decades, HP-hMG (Menopur) has been used for the treatment of infertility; its efficacy and safety compared to other gonadotropins have been consistently demonstrated in several prospective, randomised controlled trials and meta-analyses (Deeks et al 2018; Bordewijk et al 2019). Menopur powder for reconstitution is available in multidose and single dose formulations. Up to 3 single dose vials (each containing 75 IU) may be dissolved into 1 mL solvent for administration. Recently, and for the first time, Menopur has been successfully formulated in a stable, ready-to-use solution for injection, which may be administered by a pre-filled pen. Study design, size, duration This was a randomised, two-way crossover, single dose, bioequivalence trial comparing Menopur liquid injected by pre-filled pen, with Menopur powder injected by conventional syringe and needle. The primary endpoints were AUCt and Cmax of baseline-adjusted FSH. Pituitary-suppressed, healthy women were randomised to receive one treatment sequence including a single subcutaneous injection of 450 IU Menopur liquid (600 IU/0.96 mL) and of 450 IU Menopur powder by two subcutaneous injections of 225 IU in 1 mL. Participants/materials, setting, methods Blood samples were collected pre- and post-dose, until 9 days after each injection. The PK parameters of FSH and hCG were assessed by noncompartmental methods with adjustment for endogenous pre-dose levels. Highly sensitive and specific electrochemiluminescence immunoassays were used for quantification and the LLOQ of the FSH and hCG assays were 1.47 mIU/mL and 0.5 mIU/mL, respectively, and the total validated CV was within 5% for both assays. Main results and the role of chance In total, 76 women were randomised and 56 completed the trial. The main reason for discontinuation was insufficient pituitary suppression prior to the second administration of HP-hMG. The mean FSH and hCG serum concentration-time profiles were comparable between the two HP-hMG formulations. The geometric mean ratios and 90% confidence intervals of FSH for HP-hMG liquid versus HP-hMG powder were 1.12 [1.0562; 1.1889] for AUCt and 1.17 [1.0946; 1.2490] for Cmax, showing that the two formulations were bioequivalent. Maximal serum FSH concentrations were reached at 18.19 h for HP-HMG liquid and 15.55 h for HP-hMG powder. In addition to FSH, the PK parameters for hCG were compared between the two HP-hMG formulations. The geometric mean ratios and 90% confidence intervals for HP-hMG liquid versus HP-hMG powder were 0.93 [0.86; 1.01] for AUCt and 0.94 [0.86; 1.02] for Cmax. There was no difference between the two groups in the incidence or severity of adverse events, and both preparations were well tolerated. Mild injection site reactions were less common after administration of HP-hMG liquid by a single injection compared to HP-hMG powder by two injections and were mostly related to pain and erythema after drug administration. Limitations, reasons for caution This bioequivalence study is based on the comparison of single dose administrations in healthy female volunteers of reproductive age. Wider implications of the findings: The new HP-hMG solution for injection in a pre-filled pen will deliver the efficacy and safety of Menopur in a convenient delivery device. Trial registration number NA

Rare Types of Ectopic Pregnancies

The purpose of this review is to inform readers of recent discussions and findings regarding the underlying aetiology and clinical management of rare ectopic pregnancies. Risk factors, early diagnosis, treatment and results of rare ectopic pregnancies are discussed. New surgical/medical modalities and methods that facilitate early diagnosis are shared. With the widespread use of ultrasonography and hcg assays, the diagnosis of ectopic pregnancy is increasing. At the same time, the increase in risk factors (IVF, previous surgeries, pelvic infections) also increases the rare diagnosis of ectopic pregnancy. Accordingly, the probability of detecting rare types increases. There is no clear consensus for the treatment of rare types, but early diagnosis is important to prevent maternal morbidity and mortality, and allows fertility to be preserved in cases in the reproductive age. In conclusion, when ectopic pregnancy is suspected, as well as diagnosis of ectopic pregnancy, non-tubal and other rare types should be considered when no tubal ectopic is detected. Past medical and surgical treatments of the patient should be thoroughly questioned to determine risk factors.

Urinary Tract Infection With Gram-Positive Bacteria Does Not Cause False-Positive Results with the Urine-Based Human Chorionic Gonadotropic Point-of-Care Assay.

False-positive results for human chorionic gonadotropic (hCG) on point-of-care (POC) devices can occur for a variety of technical and biological reasons. It has been postulated that urinary tract infection can result in false-positive POC hCG assays, but the cause of this phenomenon remains elusive. Gram-positive bacteria have previously been reported to express an hCG-like molecule. We investigated whether urinary tract infection with Gram-positive bacteria can result in false-positive POC hCG. We utilized remnant clinical urine specimens that had been submitted for culture as part of evaluation for urinary tract infection. Urine specimens with >100,000 colony-forming units per milliliter of Gram-positive bacteria (n = 95) were tested on ICON 20 POC hCG tests (Beckman Coulter). Specimens from adult patients that had been collected for clinical testing in the prior 48 hours were included in the study, and only 1 specimen per patient was included. Of 95 patients with Gram-positive urine specimens, 42 (44%) were female, and the median age was 62 years. The most common bacteria identified during clinical urine culture of these patients' specimens were coagulase-negative Staphylococcus species (36/95, 38%), Enterococcus species (34/95, 36%), and Streptococcus agalactiae (9/95, 9%). Five of 95 (5.3%) urine specimens were positive for POC hCG. Chart review revealed that 3 specimens were from pregnant women and 2 were from patients with cancer diagnoses. Urine specimens from patients suspected to have urinary tract infection with Gram-positive organisms did not cause positive results on POC hCG test devices.

SUN-523 Thyroid Storm: A Rare Presentation of HCG Producing Metastatic Choriocarcinoma

Background: The beta subunit of human Chorionic Gonadotropin (hCG) and TSH are very similar and hCG is known to weakly bind the TSH receptor. hCG induced hyperthyroidism has been previously reported as a rare paraneoplastic syndrome in non-seminomatous germ-cell tumors and usually presents with subclinical thyrotoxicosis. We present a noteworthy case of thyroid storm in a patient with hCG producing testicular Choriocarcinoma. Clinical case: A 19-year-old Hispanic man presented to an outside emergency department (ED) with one day of abdominal pain, nausea, recurrent emesis and subjective fever. He had presented to the same ED 9 days prior with similar symptoms which prompted contrasted CT Abdomen/Pelvis demonstrating hepatic masses and a large right testicular mass, suspicious for primary testicular malignancy. On return evaluation, he was noted to have tachycardia with HR 165, mild scleral icterus, tenderness to palpation of right upper quadrant, abdominal pain and a right scrotal mass (5x5 cm). CBC revealed; WBC 12.0 k/uL (n: 4-10.8), AST: 428 u/L (n: 3-34); ALT: 176 u/L (n: 15-41); total bilirubin: 6.3 mg/dL (n: 0.2-1.3), TSH <0.005 uIU/mL (n: 0.4-4.0) and FT4 5.02 ng/dL (n: 0.7-1.4). Clinical scenario was consistent with thyrotoxicosis concerning for thyroid storm (Burch-Wartofsky Point Scale: 50) requiring intensive care for which he was transferred to our institution. Thyroid US revealed increased thyroid vascularity without nodularity. Laboratory workup revealed negative TG Ab, Anti-TPO Ab, TRAb, and TSIG. Conversely, TBG was elevated at 31.2 mcg/ml (n: 13-30). Initial hCG level was obtained as 6,074. After re-testing with dilution was specifically requested, initial hCG was corrected to 6,760,713. Oncologic workup confirmed diagnosis of hCG producing testicular choriocarcinoma with liver and lung metastases. On admission, he was started on oral methimazole and propranolol as well as intravenous steroids which led to marked symptomatic improvement and normalization of FT4 to 1.37 allowing for discontinuation of antithyroid medication on 7th day of hospitalization. He completed 1 cycle of cisplatin/etoposide and experienced marked reduction of his hCG level to 951,460 which correlated with improvement of his TFTs and resolution of his hyperthyroid symptoms.Conclusion:A low threshold of suspicion should be maintained for the possibility of hyperthyroidism in patients with suspected testicular choriocarcinoma, particularly in the context of recent iodinated contrast imaging. If the clinical picture does not support a primary etiology of hyperthyroidism and hCG is not concordantly elevated, re-assessment of hCG by dilution should be considered as hCG assay is also subject to prozone (hook) effect. Hyperthyroidism should be actively managed and closely monitored as response to treatment can be rapid.

Vaginal birth after laparoscopic management of heterotopic pregnancy at the Douala general hospital, Cameroon: A case report

Heterotopic pregnancy is the simultaneous presence of an intrauterine and ectopic pregnancy. The prevalence of the condition is unknown in Cameroon. We report a case of heterotopic pregnancy managed by laparoscopy. MS a 33-year-old G2P0010 woman was admitted to our department because of 7 2/7 weeks' amenorrhea, mild vaginal bleeding, and severe lower abdominal pain. She has a 6 years' history of secondary infertility, one induced abortion, and chlamydia infection treated with doxycycline. Furthermore, she has a history of left laparoscopic salpingotomy for tubo-ovarian abscess. She became pregnant after receiving clomiphene citrate and timed intercourse. Her beta hCG assay was 97000 mIU/mL and transvaginal sonography confirmed ruptured heterotopic pregnancy. She underwent laparoscopic left salpingectomy and the intrauterine pregnancy evolved normally and she gave birth to a healthy female that weighed 3050 g at 38 5/7 weeks gestation. The diagnosis of heterotopic pregnancy needs a high index of suspicion. Laparoscopic treatment of heterotopic pregnancy needs to become widespread in Cameroon.

Guideline-based quality indicators for early pregnancy assessment units

What valid guideline-based quality indicators can measure quality of care in early pregnancy assessment units (EPAU)? The systematic RAND-modified Delphi method was used to develop an indicator set from four evidence-based guidelines. An international expert panel was assembled to extract recommendations from these guidelines to establish quality indicators. A total of 119 recommendations were extracted. Eleven recommendations received a high median score and top five score above the 75th percentile and were selected as key recommendations. The expert panel reassessed 15 high score recommendations and top five score between the 50th and 75th percentile as well as one high score recommendation without consensus. Eight of these 16 recommendations were selected in the second round as key recommendations. The key recommendations were formulated into a set of 19 quality indicators, summarized as follows: women referred to an EPAU could be seen within 24 h and receive a clear explanation on treatment options; designated senior staff members could be responsible for the unit and staff could have had ultrasound training; protocols could be available for daily practice covering all treatment options for miscarriage and ectopic pregnancy; and an EPAU could have access to urine pregnancy testing and serum HCG assays. Nineteen quality indicators to measure early pregnancy care provided by EPAU were identified.

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

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.

Le point sur les dosages de l’hormone gonadotrophine chorionique : lequel prescrire pour quelle prise en charge ?

The point on chorionic gonadotropin assays: which tests prescribe for the best take care? hCG assays are very often prescribed for biological investigations or before medical investigations. Physicians and biologists have to discuss about these different available hCG assays for an optimal patient's follow-up. Patients must be advised to have blood sample in the same laboratory to avoid analytical variations, possibly prejudiciable in case of cinetic observations.

Facile Fabrication of Surface-Imprinted Macroporous Films for Chemosensing of Human Chorionic Gonadotropin Hormone.

We present an improved approach for the preparation of highly selective and homogeneous molecular cavities in molecularly imprinted polymers (MIPs) via the combination of surface imprinting and semi-covalent imprinting. Toward that, first, a colloidal crystal mold was prepared via the Langmuir-Blodgett(LB) technique. Then, human chorionic gonadotropin (hCG) template protein was immobilized on the colloidal crystal mold. Later, hCG derivatization with electroactive functional monomers via amide chemistry was performed. In a final step, optimized potentiostatic polymerization of 2,3'-bithiophene enabled depositing an MIP film as the macroporous structure. This synergistic strategy resulted in the formation of molecularly imprinted cavities exclusively on the internal surface of the macropores, which were accessible after dissolution of silica molds. The recognition of hCG by the macroporous MIP film was transduced with the help of electric transducers, namely, extended-gate field-effect transistors (EG-FET) and capacitive impedimetry (CI). These readout strategies offered the ability to create chemosensors for the label-free determination of the hCG hormone. Other than the simple confirmation of pregnancy, hCG assay is a common tool for the diagnosis and follow-up of ectopic pregnancy or trophoblast tumors. Concentration measurements with these EG-FET and CI-based devices allowed real-time measurements of hCG in the range of 0.8-50 and 0.17-2.0 fM, respectively, in 10 mM carbonate buffer (pH = 10). Moreover, the selectivity of chemosensors with respect to protein interferences was very high.

Negative interference in a hCG assay from anti-streptavidin antibody

Negative interference in a hCG assay from anti-streptavidin antibody

Analytical evaluation of the Radiometer AQT90 FLEX βhCG assay

ObjectivesMany hospitals cannot afford an hCG assay on a central lab analyzer and turn to point of care testing (POCT) solutions. The Radiometer AQT90 FLEX is a small benchtop immunoareement between the AQT90 and comparator methods for samples with hCG ssay analyzer for use in the laboratory or at the patient bedside. This study evaluated the analytical performance of the AQT90's βhCG assay. MethodsPrecision was assessed using whole blood patient samples and two levels of quality control. Linearity was assessed by dilution of a high hCG plasma sample. Carryover and hook effect were assessed using high and low hCG samples. Method comparisons were done against Abbott i-STAT Total βhCG, Beckman Coulter Total βhCG (5th IS), and Roche hCG+β. Sample concentrations ranged from<2 IU/L to 4,973 IU/L. ResultsRepeatability and within-laboratory precision passed most manufacturer's claims and allowable error criteria. Linearity was validated from<2 IU/L to 4,741 IU/L. Hook effect was not observed up to 2,446,448 IU/L. Carryover was<4.0 ppm. A linear relationship was observed with i-STAT, Beckman and Roche methods. At>20 IU/L, biases were apparent against all three comparator assays (i-STAT: +20%, Roche: +30%, Beckman: +5 to 15%). At ≤20 IU/L, the acceptability of agreement varied according to TAE specifications. Concordance between AQT90 and comparator assays using 5 IU/L as the medical decision level ranged from 69% to 81%. ConclusionsOverall, the AQT90 hCG assay performed well and would be suitable for smaller suburban or rural hospitals. Some limitations have been noted and should be kept in mind during clinical testing.