Beta-human chorionic gonadotrophin point of care testing for the management of pregnancy of unknown location.

RESEARCH QUESTION: Does a commercially available quantitative beta-human chorionic gonadotrophin (BHCG) point of care testing (POCT) device improve workflow management in early pregnancy by performing comparably to gold standard laboratory methods, and is the performance of a validated pregnancy of unknown location (PUL) triage strategy maintained using POCT BHCG results? DESIGN: Women classified with a PUL between 2018 and 2021 at three early pregnancy units were included. The linear relationship of untreated whole-blood POCT and serum laboratory BHCG values was defined using coefficients and regression. Paired serial BHCG values were then incorporated into the validated M6 multinomial logistic regression model to stratify the PUL as at high risk or at low risk of clinical complications. The sensitivity and negative predictive value were assessed. The timings required for equivocal POCT and laboratory care pathways were compared. RESULTS: A total of 462 PUL were included. The discrepancy between 571 laboratory and POCT BHCG values was -5.2% (-6.2 IU/l), with a correlation coefficient of 0.96. The 133 PUL with paired 0 and 48 h BHCG values were compared using the M6 model. The sensitivity for high-risk outcomes (96.2%) and negative predictive values (98.5%) was excellent for both. Sample receipt and laboratory processing took 135 min (421 timings), compared with 12 min (91 timings) when using POCT (P < 0.0001). CONCLUSIONS: POCT BHCG values correlated well with laboratory testing measurements. The M6 model retained its performance when using POCT BHCG values. Using the model with POCT may improve workflow and patient care without compromising on effective PUL triage.

Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices.

OBJECTIVES: Quantitative human chorionic gonadotropin (hCG) measurements are used to manage women classified with a pregnancy of unknown location (PUL). Two point of care testing (POCT) devices that quantify hCG are commercially available. We verified the i-STAT 1 (Abbott) and the AQT 90 FLEX (Radiometer) prior to use in PUL triage. METHODS: Tests for precision, external quality assurance (EQA), correlation, hook effect and recovery were undertaken alongside a POCT usability assessment during this prospective multi-center verification. RESULTS: Coefficients of variation ranged between 4.0 and 5.1 % for the three i-STAT 1 internal quality control (IQC) solutions and between 6.8 and 7.3 % for the two AQT IQC solutions. Symmetric differences in POCT EQA results when compared with laboratory and EQA stock values ranged between 3.2 and 24.5 % for the i-STAT 1 and between 3.3 and 36.9 % for the AQT. Correlation coefficients (i-STAT 1: 0.96, AQT: 0.99) and goodness of fit curves (i-STAT 1: 0.92, AQT: 0.99) were excellent when using suitable whole blood samples. An hCG hook effect was noted with the i-STAT 1 between 572,194 and 799,089 IU/L, lower than the hook effect noted with the AQT, which was between 799,089 and 1,619,309 IU/L. When hematocrit concentration was considered in sample types validated for use with each device, hCG recovery was 108 % with the i-STAT 1 and 98 % with the AQT. The i-STAT 1 scored lower on usability overall (90/130) than the AQT (121/130, p<0.001, Mann-Whitney). CONCLUSIONS: Both hCG POCT devices were verified for use in clinical practice. Practical factors must also be considered when choosing which device to use in each unit.

Does temperature of distending medium matter in outpatient hysteroscopy? A double-blinded cohort control observational study of room temperature versus warmed saline.

AIM: There is little data assessing outcomes of outpatient hysteroscopy using warmed versus room temperature saline. The aim of this study was to determine if the temperature of the distending medium during outpatient hysteroscopy affect ease of procedure, clarity of view, procedural discomfort/pain and patient satisfaction. METHODS: This was a double-blinded cohort control quasi-randomized prospective study involving 100 women undergoing outpatient diagnostic and operative hysteroscopy for abnormal uterine bleeding, intrauterine contraceptive devices retrieval and removal of endometrial polyps. Outpatient hysteroscopy was performed either with normal saline either at room temperature (control at 25°C) or warmed to body temperature (37°C). RESULTS: Confounding variables such as age, parity, previous cervical surgery, previous vaginal births, menopausal status and indications for hysteroscopy were similar in the room temperature (n = 48) and warmed saline (n = 52) groups. Mean procedure duration (256 vs 233 s), ease of entry (Visual Analogue Scale [VAS] 9.55 vs 9.4) and the clarity of view (VAS 9.02 vs 9.3) were statistically similar in both groups (all P > 0.05) as was discomfort experienced during hysteroscopy (VAS 6.6/10 vs 6.8/10) and at 5 min post-procedure (VAS 4.2/10 vs 3.2/10) (both P > 0.05). The likelihood of recommending the procedure to a friend was similar in both groups (mean VAS 6.9/10 vs 7.2/10; P = 0.1). CONCLUSION: The temperature of the distension medium did not influence ease of procedure, clarity of hysteroscopy view, procedural discomfort/pain and patient satisfaction. Patients were not any more likely to recommend the procedure to a friend in the warmed saline compared to the room temperature group.