Impact of regression modeling on the assessment and harmonization of a point-of-care analyzer and commercial laboratory analyzer for feline plasma biochemistry testing.

BACKGROUND: Regression describes the relationship of results from two analyzers, and the generated equation can be used to harmonize results. Point-of-care (POC) analyzers cannot be calibrated by the end user, so regression offers an opportunity for calculated harmonization. Harmonization (uniformity) of laboratory results facilitates the use of common reference intervals and medical decision thresholds. OBJECTIVE: Our aims were to characterize the relationship of results for multiple biochemistry analytes on a POC and a commercial laboratory analyzer (CL) with three regression techniques and to use regression equations to harmonize the POC results with those of the CL. Harmonized results were assessed by recognized quality goals. We used harmonized results to assess the regression techniques. METHODS: After analyzer imprecision assessments, paired clinical samples were assessed with one dataset to calculate regression parameters that were applied to a second dataset. Three regression techniques were performed, and each was used to harmonize the POC results with those from the CL. POC results were assessed for bias and the number of results reaching quality goals before and after harmonization. RESULTS: All regression techniques could be used to harmonize most analytes so that 95% of results were within ASVCP TEa guidelines. Harmonization could be further improved with alternate regression techniques or exclusions. CONCLUSIONS: Regression offers a means to harmonize POC and CL analyzers. Further work is needed to assess how few samples can reliably be used and to assess likely species differences. No regression technique reliably describes the relationship between methods when correlation is poor.

Accuracy and technical characteristics of CYP2C19 point of care tests: a systematic review.

Aim: To assess the accuracy and technical characteristics of CYP2C19 point of care tests (POCTs).Patients & methods: Systematic review of primary studies, in any population or setting, that evaluated POCTs for detecting CYP2C19 loss of function (LOF) alleles.Results: Eleven studies provided accuracy data (eight Spartan; one Genomadix Cube; one GMEX; one Genedrive). The POCTs had very high sensitivity and specificity for the alleles they tested for. Twenty-two studies reported technical characteristics: POCTs were easy to operate and provided results quickly. Limited data were reported for test failure rate and cost.Conclusion: CYP2C19 POCTs may be a useful alternative to laboratory-based testing to guide antiplatelet therapy. Further data are required on accuracy (GMEX; Genedrive), test failure and cost (all POCT).

[Box: see text].

Performance evaluation of the glycated hemoglobin A1c analyzer for point-of-care testing compared with laboratory-based devices: a multicenter validation study.

In this dual-center study, we assessed the BioHermes A1C EXP M13 system for point-of-care (POC) HbA1c testing against two NGSP-certified HPLC instruments, the Bio-Rad D100 and Tosoh G8. Analyzing 605 samples, we evaluated the A1C EXP's reproducibility, sensitivity, specificity and impact of anemia on HbA1c measurements. The device showed excellent reproducibility with CVs under 2.4% and high sensitivity and specificity for diabetes diagnosis-98.1% and 96.8% against D100, and 97.1% and 96.7% against G8. Passing-Bablok regression confirmed a close correlation between A1C EXP and the HPLC instruments, with equations y = 0.10625 + 0.9688x (D100) and y = 0.0000 + 0.1000x (G8), and Bland-Altman plots indicated mean relative differences of -1.4% (D100) and -0.4% (G8). However, in anemic samples, A1C EXP showed a negative bias compared to HPLC devices, suggesting that anemia may affect the accuracy of HbA1c results. The study indicates that A1C EXP is a reliable POC alternative to laboratory assays, albeit with considerations for anemic patients.

Performance evaluation and characterization of pre-analytical effects by sample types and storage conditions on tumor marker measurement by the point-of-care test platform IchromaTM II.

Tumor markers should be measured regularly and accurately to prevent, diagnose, and monitor cancers efficiently. We aimed to characterize the pre-analytical factors effecting on the analytical performance of point-of-care test (POCT) platform IchromaTM II (Boditech Med Inc., Gangwon-do, Korea) for alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and prostate specific antigen (PSA) and evaluate their consequences in clinical practice. Based on comprehensive evaluation for the analytical performance of IchromaTM II including precision, linearity, and method comparison performed according to CLSI guidelines, pre-analytical factors of sample types and conditions were extensively analyzed. A total of five sample types [serum, plasma (PL) and whole blood (WB) from EDTA tube, PL and WB from sodium heparin tube] from 40 patients were used for comparing among specimen types. Additionally, stability was assessed up to 21 h at room temperature, refrigerated for 8 days, and frozen for 16 weeks by using 4 levels of pooled patient samples which were measured in triplicate. Precision, linearity and correlation with central laboratory analyzers observed in all three tumor markers were within acceptable criteria. However, variable degrees of percent deviations were observed according to sample type and storage conditions. Only EDTA PL samples presented clinically acceptable percentage biases for all three tumor markers when stored at room temperature or refrigerated condition. Positive bias of CEA and PSA in storage duration until 16 weeks were observed when stored in frozen condition. While IchromaTM II showed an adequate analytical performance as a POCT platform with simple operating procedures for the measurement of tumor markers, clinical laboratories should be aware of stability issues when different types of blood specimens are practically utilized.

A 12-year Retrospective Cohort Study of Point-of-care Ultrasound and Aortic Dissection Risk Score in Type A Aortic Dissection.

BACKGROUND: Aortic dissection (AD) is a vascular emergency with time-dependent mortality. Point-of-care ultrasound (POCUS) and AD risk score (ADRS) have been proposed as diagnostic tools to risk stratify patients and reduce time to diagnosis. STUDY OBJECTIVE: We evaluate POCUS findings and ADRS in a retrospective cohort of patients with known type A AD. The objective of this study is to describe the prevalence of POCUS findings and ADRS in this population. METHODS: This is a retrospective cohort study of patients with acute type A AD as confirmed on computed tomography scan over a 12-year period from 2008 to 2020, with a subgroup analysis of patients who received POCUS in the emergency department. ADRS was calculated and POCUS findings were reviewed. Descriptive statistics were used to describe the distribution of POCUS findings. RESULTS: Ninety-one patients met inclusion criteria. POCUS was performed in 41 but only 35 had images of adequate quality for inclusion. Of the POCUS images available, 30/35 (86%) patients had a POCUS finding consistent with dissection and 5/35 (14%) had no findings on POCUS. Twelve percent (11/91) of patients had ADRS = 0. Two patients with ADRS = 0 received POCUS, and one patient had no findings on POCUS. CONCLUSION: Although POCUS provides rapid information in the diagnosis of type A AD, 14% of patients with images available for review had no findings on POCUS. Of the whole cohort, 12% had an ADRS = 0. Further studies are needed to identify an optimal diagnostic pathway for this catastrophic disease.

A veterinary-calibrated point-of-care glucometer accurately measures blood glucose concentration in dogs and cats.

OBJECTIVE: To determine the clinical and analytical accuracy of a new veterinary-calibrated portable blood glucose monitor (PBGM) compared to a reference laboratory analyzer. ANIMALS: Client-owned dogs (n = 77) and cats (n = 64). METHODS: Peripheral and paired capillary whole-blood glucose concentrations measured via PBGM were compared to plasma glucose concentrations measured via a Cobas c501 reference analyzer (Roche). Analytical accuracy was evaluated with the Spearman rank correlation coefficient, Bland-Altman difference plot analysis, and Deming regression. Clinical accuracy was evaluated with Parkes error grid analysis. Paired peripheral and capillary blood samples were compared with the Wilcoxon matched-pairs signed-rank test. RESULTS: There was a high correlation between PBGM and reference analyzer readings in dogs and cats. Human quality assurance standards (International Organization for Standardization 15197:2013 guidelines) for analytical accuracy were met for 95% of feline peripheral blood samples and 89% of canine samples. Similar veterinary standards (American Society of Veterinary Clinical Pathology guidelines) were met for 89% of canine and 92% of feline peripheral blood glucose measurements. Error grid analysis showed that all peripheral canine and 97% of feline measurements were clinically accurate (zone A). Any altered clinical decision for the remaining feline measurements was expected to minimally impact outcome (zone B). No significant difference was found between peripheral and capillary blood glucose measurements in either species. CLINICAL RELEVANCE: The PBGM produced clinically accurate results and is suitable for use in veterinary and home settings to measure blood glucose.

Optic Nerve Sheath Diameter Point-of-Care Ultrasonography Quality Criteria Checklist: An International Consensus Statement on Optic Nerve Sheath Diameter Imaging and Measurement.

OBJECTIVES: To standardize optic nerve sheath diameter (ONSD) point-of-care ultrasonography (POCUS) and improve its research and clinical utility by developing the ONSD POCUS Quality Criteria Checklist (ONSD POCUS QCC). DESIGN: Three rounds of modified Delphi consensus process and three rounds of asynchronous discussions. SETTING: Online surveys and anonymous asynchronous discussion. SUBJECTS: Expert panelists were identified according to their expertise in ONSD research, publication records, education, and clinical use. A total of 52 panelists participated in the Delphi process. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Three Delphi rounds and three asynchronous discussion rounds generated consensus on quality criteria (QC). This started with 29 QC in addition to other QC proposed by expert panelists. The QC items were categorized into probe selection, safety, body position, imaging, measurement, and research considerations. At the conclusion of the study, 28 QC reached consensus to include in the final ONSD POCUS QCC. These QC were then reorganized, edited, and consolidated into 23 QC that were reviewed and approved by the panelists. CONCLUSIONS: ONSD POCUS QCC standardizes ONSD ultrasound imaging and measurement based on international consensus. This can establish ONSD ultrasound in clinical research and improve its utility in clinical practice.

Bedside Nurse Documentation Practices: At the Patient Bedside or Not?

High-quality care requires precise and timely provider documentation. Hospitals have used technology to document patient care within both the inpatient and outpatient areas and long-term care facilities. Research has demonstrated, by revealing a reduction in medical errors, that there has been a worldwide improvement in our community health and welfare since the implementation and utilization of documenting patient care electronically. Although electronic documentation has proven to be an improvement in patient record keeping, the most efficient location in which this documentation is to occur remains a question. At the location where this project took place, only the ICU had computers within the patient rooms for documentation purposes. This project evaluated bedside nurses' opinions related to the efficiency of documentation practices compounded by the location where documentation took place. The options were at the patient's bedside, on a workstation on wheels, or at the nursing station. Surveys were provided to bedside nursing staff both before and after computers were installed in patients' rooms in surgical and medical/surgical nursing units at a Veteran Affairs Medical Center located in the Northeastern region of the United States. The results of this project inconclusively answer the question posed: "Which mode of entry do nurses feel is more efficient to document patient care, on a computer in the patient room, at the nurses' station, or on a workstation on wheels?" Innovative strategies should be explored to develop a user-friendly design for computers located within the patient rooms for patient documentation.

Agreement of point of care ultrasound and final clinical diagnosis in patients with acute heart failure, acute coronary syndrome, and shock: POCUS not missing the target.

Point-of-care ultrasound (POCUS) is an important tool for clinical diagnosis and decision-making in critical and non-critical scenarios. Dyspnea, chest pain, and shock are conditions susceptible to evaluation with ultrasound considering diagnostic accuracy and clinical impact already proven. There is scarce evidence in diagnosis agreement using ultrasound as an extension of physical examination. We aimed to evaluate ED patients in whom POCUS was performed, to analyze agreement between clinical initial diagnosis using ultrasound images and final diagnosis. Furthermore, we analyze failed diagnosis, inconclusive POCUS exams, and discuss details. A cross-sectional analytical study was conducted on adults who visited the emergency department with any of these three chief complaints: dyspnea, chest pain, and shock. All were evaluated with ultrasound at admission. Agreement between initial diagnosis using POCUS and final definite diagnosis was calculated. Failed diagnosis and inconclusive exams were analyzed. A total of 209 patients were analyzed. Populations: mostly males, mean age 64 years old, hypertensive. Agreement on patients with dyspnea and suspicion of acute decompensated heart failure was 0.98; agreement on chest pain suspicion of non-ST acute coronary syndrome was 0.96; agreement on type of shock was 0.90. Among the population, 12 patients had an inconclusive POCUS exam, and 16 patients had a failed diagnosis. The use of POCUS in the emergency department shows almost perfect agreement when compared with the final diagnosis in individuals experiencing acutely decompensated heart failure, acute coronary syndrome, and shock. Prospective studies are needed to evaluate the impact of this tool on mortality and prognosis when there are diagnostic errors.

Analytical performance and user-friendliness of four commercially available point-of-care devices for C-reactive protein.

INTRODUCTION: Proper implementation of Point-of-Care testing (POCT) for C-reactive protein (CRP) in primary care can decrease the inappropriate use of antibiotics, thereby tackling the problem of growing antimicrobial resistance. OBJECTIVE: The analytical performance and user-friendliness of four POCT-CRP assays were evaluated: QuikRead go easy, LumiraDx, cobas b 101 and Afinion 2. MATERIALS AND METHODS: Imprecision was evaluated using plasma pools in addition to manufacturer-specific control material. Trueness was assessed by verification of traceability to ERM-DA474/IFCC in parallel to method comparison towards the central laboratory CRP method (cobas c 503) using i) retrospectively selected plasma samples (n = 100) and ii) prospectively collected capillary whole blood samples (n = 50). User-friendliness was examined using a questionnaire. RESULTS: Between-day imprecision on plasma pools varied from 4.5 % (LumiraDx) to 11.5 % (QuikRead). Traceability verification revealed no significant difference between cobas c 503 CRP results and the ERM-DA474/IFCC certified value. cobas b 101 and Afinion achieved the best agreement with the central laboratory method. LumiraDx and QuikRead revealed a negative mean difference, with LumiraDx violating the criterion of > 95 % of POCT-CRP-results within ± 20 % of the comparison method. Regarding user-friendliness, Afinion obtained the highest Likert-scores. CONCLUSION: The analytical performance and user-friendliness of POCT-CRP devices varies among manufacturers, emphasizing the need for quality assurance supervised by a central laboratory.

Characterizing Point-of-Care Ultrasound Credentialing in Pediatric Emergency Departments.

OBJECTIVE: It is unclear which pediatric emergency departments (PEDs) have a point-of-care ultrasound (POCUS) credentialing process or if this process is consistent per expert guidelines. Our objective was to describe formalized POCUS credentialing processes across PEDs that are active in the pediatric emergency medicine POCUS (P2) Network. METHODS: A survey was developed from nationally recommended credentialing guidelines. This anonymous survey was sent out to the P2 Network comprising more than 230 members involved in pediatric POCUS. The survey was analyzed using descriptive analysis with counts and percentages. RESULTS: A total of 36 PEDs responded to the survey. All departments had a faculty member in charge of maintaining the credentialing process, and all faculty members had POCUS education available; 88.6% of education was scheduled didactics or bedside teaching. There were 80.6% of PEDs that had a process for internally credentialing faculty. Some PEDs offered protected education for POCUS, however, 44.8% had <50% of their faculty credentialed. There were 4 PEDs that offered incentives for completion of POCUS credentialing including salary bonuses; only 1 offered shift buy down as incentive. That PED had 100% of its faculty credentialed. All PEDs performed quality assurance on POCUS scans done in the ED, most done weekly. Billing for scans occurred in 26 PEDs. Skin/soft tissue and focused assessment with sonography for trauma were the 2 most common applications credentialed. CONCLUSIONS: Among PEDs surveyed, there was a lack of standardization of POCUS resources and components of credentialing. Incentives may be beneficial in improving credentialing faculty and standardizing the credentialing process.

Usefulness of an Ultrasound-guided Prehospital Care for SCUBA Diving Accidents.

The incidence of diving accidents is increasing. Point-of-care ultrasound is the only imaging tool available in the field for the military physician who practices in isolated conditions. While ultrasound is integrated in the pre-hospital evaluation protocols of severe trauma patients, few applications are described for diving accident victims. Through a clinical case, we propose an algorithm of ultrasound triage for diving accidents with pulmonary symptoms. Point-of-care ultrasound makes it possible to avoid a risky transfer, by supporting a diagnosis and the treatment on the spot, to rule out contraindications to recompression, and to detect and monitor the treatment of high-risk complications such as the capillary leak syndrome.

Point of Care Ultrasounds Obtained by Novice Physician Assistant Residents (POCUS ON PAR).

INTRODUCTION: The integration of Point of Care Ultrasound (POCUS) into the care of trauma patients, specifically the E-FAST, has improved the accuracy of initial diagnoses and improved time to surgical intervention in critically ill patients. Physician assistants (PAs) are critically important members of any military trauma resuscitation team and are often team leaders in a pre-hospital setting. They may receive training in ultrasound but there are little data to support their use or evaluate their effectiveness in using POCUS. We designed a study to evaluate the image quality of an E-FAST Exam performed by Emergency Medicine Physician Assistant (EMPA) Fellows and Emergency Medicine (EM) Interns following identical training. Our hypothesis is that image quality obtained by EMPAs will be non-inferior to those images obtained by EM Interns. MATERIALS AND METHODS: This is a prospective single-blinded study comparing the image quality of E-FAST exams performed by first year EM interns and first year EMPA fellows. All participants completed standard POCUS training prior to enrollment in the study. A total of 8 EMPAs and 8 EM first year residents completed 10 recorded E-FAST exams to be used as study images. Participants also viewed a 15-question slide show containing images of positive (6) and negative (9) E-FAST exams and recorded their interpretations. Images were reviewed by expert reviewers who were blinded to which images were collected by which group. An image quality score was recorded for each view as well as an overall image quality score. Image quality was rated on a 1 to 5 image quality scale. RESULTS: For overall image quality, the mean score for EMPAs was 3.6 ± 0.5 and for EM residents was 3.2 ± 0.5 with statistical significance favoring better image quality from the EMPAs. The time to completion for the EFAST exam for EMPAs was 4.8 ± 1.3 minutes and for interns it was 3.4 ± 1.4 minutes (P value = 0.02). There was no difference in image interpretation quiz scores between the groups (mean score 92% among interns and 95% among PAs). CONCLUSIONS: POCUS is an imaging modality which is very portable and relatively inexpensive which makes it ideal for military medicine. PAs are essential members of military trauma teams, and often run an initial trauma resuscitation. Being able to correctly identify patients who have free fluid early in the course of treatment allows for more correct evacuation criteria to ensure the sickest patients get to care the fastest. Although there are limited data to support POCUS use by non-physicians, our data support a growing body of evidence that it is not the profession or baseline medical education that determines an individual's ability to use and incorporate ultrasound into bedside and clinical practice. Our study shows that with training and experience PAs or other members of the military health care team can use the EFAST to better care for trauma patients.

Improvement of point of care testing device for accurate whole blood glucose measurement in early neonates.

BACKGROUND: It is important that blood glucose concentrations be accurately and conveniently measured in infants. However, especially in the early neonatal period, point-of-care testing devices used for adults may not accurately measure blood glucose concentrations in neonates. METHODS: In Study 1, the accuracy of neonatal whole-blood glucose measurements was evaluated for the existing glucose analyser Glutest Mint® (hereinafter MINT1; Sanwa Kagaku Kenkyusho, Nagoya, Japan) by comparing the data with reference blood glucose concentrations. In Study 2, we used MINT2, which was modified based on the findings from Study 1, to measure whole-blood glucose concentrations in newborns, and the accuracy of the measurements was compared with that of MINT1. RESULTS: Blood glucose concentrations were measured in 100 infants each in Study 1 and 2. In Study 1, the whole-blood glucose concentrations measured using MINT1 were found to be significantly lower than the reference blood glucose concentrations in early neonates. The results of Study 1 suggested that characteristics of erythrocyte membranes in early neonates affected the measurements. Therefore, we conducted Study 2 using MINT2, which was modified to be less susceptible. MINT2 was found to accurately measure whole-blood glucose concentrations in the early neonatal period. CONCLUSION: The study showed that the point-of-care testing device could be improved to allow for accurate whole-blood glucose measurements in the early neonatal period.

CoaguChek and Coag-Sense PT2 Meter Point of Care INR Device Validation.

OBJECTIVE: To standardize international normalized ratio (INR) measurements and improve data integrity by enabling electronic result transmission for warfarin monitoring, two point-of-care (POC) devices were evaluated against an internal plasma INR reference method. METHODS: A multicenter study was pursued (January 24, 2022, through October 19, 2022) to compare concordance of two commercially available POC devices, Coag-Sense PT2 Meter (Coag-Sense) and CoaguChek XS Pro and Plus devices (CoaguChek), against an internal plasma INR method among patients treated with warfarin. Bias and linear regression analysis were assessed for these devices including dosing decision accuracy compared with plasma INR reference. RESULTS: Two hundred ninety-nine patients treated with warfarin across three Mayo Clinic sites agreed to participate. Atrial fibrillation (n=191, 63.9%), venous thromboembolism (n=65; 21.7%), and heart valve prosthesis (n=46; 15.4%) were common anticoagulant indications with a 2.5 INR target for 280 (93.6%) of patients. For the CoaguChek devices, 243 (81.3%) of values fell within 0.2 INR units with plasma INR referent and 285 (95.3%) within 0.4 units (R2=0.93). For the Coag-Sense device, 102 (34.1%) of values fell within 0.2 INR units and 180 (60.2%) within 0.4 INR units of plasma INR values, (R2=0.83; P<.0001). Using the plasma INR as the gold standard, appropriate dosing recommendations would have occurred for 292 (97.7%) of the CoaguChek and 244 (81.6%) of the Coag-Sense results. CONCLUSION: Compared with a plasma referent, INR values obtained from the CoaguChek devices exhibited less systematic bias compared with Coag-Sense measures. This translates to a greater percentage of concordant management decisions between POC and laboratory INR methods.

Point-of-care ultrasound in pediatric anesthesiology: considerations for training and credentialing.

PURPOSE OF REVIEW: To discuss considerations surrounding the use of point-of-care ultrasound (POCUS) in pediatric anesthesiology. RECENT FINDINGS: POCUS is an indispensable tool in various medical specialties, including pediatric anesthesiology. Credentialing for POCUS should be considered to ensure that practitioners are able to acquire images, interpret them correctly, and use ultrasound to guide procedures safely and effectively. In the absence of formal guidelines for anesthesiology, current practice and oversight varies by institution. In this review, we will explore the significance of POCUS in pediatric anesthesiology, discuss credentialing, and compare the specific requirements and challenges currently associated with using POCUS in pediatric anesthesia. SUMMARY: Point-of-care ultrasound is being utilized by the pediatric anesthesiologist and has the potential to improve patient assessment, procedure guidance, and decision-making. Guidelines increase standardization and quality assurance procedures help maintain high-quality data. Credentialing standards for POCUS in pediatric anesthesiology are essential to ensure that practitioners have the necessary skills and knowledge to use this technology effectively and safely. Currently, there are no national pediatric POCUS guidelines to base credentialing processes on for pediatric anesthesia practices. Further work directed at establishing pediatric-specific curriculum goals and competency standards are needed to train current and future pediatric anesthesia providers and increase overall acceptance of POCUS use.

In vitro evaluation of a new viscoelastometry-based point-of-care analyzer.

INTRODUCTION: The VCM is a point-of-care analyzer using a new viscoelastometry technique for rapid assessment of hemostasis on fresh whole blood. Its characteristics would make it suitable for use in austere environments. The purpose of this study was to evaluate the VCM in terms of repeatability, reproducibility and interanalyzer correlation, reference values in our population, correlation with standard coagulation assays and platelet count, correlation with the TEG5000 analyzer and resistance to stress conditions mimicking an austere environment. METHODS: Repeatability, reproducibility, and interanalyzer correlation were performed on quality control samples (n = 10). Reference values were determined from blood donor samples (n = 60). Correlations with standard biological assays were assessed from ICU patients (n = 30) and blood donors (n = 60) samples. Correlation with the TEG5000 was assessed from blood donor samples. Evaluation of vibration resistance was performed on blood donor (n = 5) and quality control (n = 5) samples. RESULTS: The CVs for repeatability and reproducibility ranged from 0% to 11%. Interanalyzer correlation found correlation coefficients (r2) ranging from 0.927 to 0.997. Our reference values were consistent with those provided by the manufacturer. No robust correlation was found with conventional coagulation tests. The correlation with the TEG5000 was excellent with r2 ranging from 0.75 to 0.92. Resistance to stress conditions was excellent. CONCLUSION: The VCM analyzer is a reliable, easy-to-use instrument that correlates well with the TEG5000. Despite some logistical constraints, the results suggest that it can be used in austere environments. Further studies are required before its implementation.

Clinical utility of point-of-care glucose testing in the assessment of gestational diabetes: Prospective cohort study.

OBJECTIVE: To assess the clinical utility of point-of-care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT). DESIGN: Prospective cohort study. SETTING: Antenatal clinics at King's College Hospital. POPULATION: Women screened for GDM between March and June 2020. METHODS: The CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse-It 5.40.2. MAIN OUTCOME MEASURES: Diagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method. RESULTS: A total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%-99%) and 97% (93%-98%) at fasting and 97% (91%-99%) and 79% (71%-84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%. CONCLUSIONS: In our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h.