Abstract：
OBJECTIVE: 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?
METHODS: 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.
METHODS: 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.
摘要：
目的：市售的定量β-人绒毛膜促性腺激素（BHCG）点检测（POCT）装置是否可以通过与金标准实验室方法进行比较来改善妊娠早期的工作流程管理，是否使用POCTBHCG结果维持了经过验证的不明部位妊娠(PUL)分诊策略?
方法:纳入了在2018年至2021年期间在3个早期妊娠单位被PUL分类的女性.使用系数和回归定义未处理的全血POCT和血清实验室BHCG值的线性关系。然后将成对的连续BHCG值合并到经过验证的M6多项逻辑回归模型中，以将PUL分层为临床并发症的高风险或低风险。评估敏感性和阴性预测值。比较了模棱两可的POCT和实验室护理途径所需的时机。
结果：共纳入462PUL。571个实验室和POCTBHCG值之间的差异为-5.2％（-6.2IU/l），相关系数为0.96。使用M6模型比较了133PUL与配对的0和48hBHCG值。对高风险结果（96.2%）和阴性预测值（98.5%）的敏感性都非常好。样品接收和实验室处理耗时135分钟(421个计时),与使用POCT时的12分钟（91个时间）相比（P<0.0001）。
结论：POCTBHCG值与实验室测试测量值相关性良好。M6模型在使用POCTBHCG值时保留了其性能。将该模型与POCT一起使用可以改善工作流程和患者护理，而不会影响有效的PUL分诊。
方法:纳入了在2018年至2021年期间在3个早期妊娠单位被PUL分类的女性.使用系数和回归定义未处理的全血POCT和血清实验室BHCG值的线性关系。然后将成对的连续BHCG值合并到经过验证的M6多项逻辑回归模型中，以将PUL分层为临床并发症的高风险或低风险。评估敏感性和阴性预测值。比较了模棱两可的POCT和实验室护理途径所需的时机。
结果：共纳入462PUL。571个实验室和POCTBHCG值之间的差异为-5.2％（-6.2IU/l），相关系数为0.96。使用M6模型比较了133PUL与配对的0和48hBHCG值。对高风险结果（96.2%）和阴性预测值（98.5%）的敏感性都非常好。样品接收和实验室处理耗时135分钟(421个计时),与使用POCT时的12分钟（91个时间）相比（P<0.0001）。
结论：POCTBHCG值与实验室测试测量值相关性良好。M6模型在使用POCTBHCG值时保留了其性能。将该模型与POCT一起使用可以改善工作流程和患者护理，而不会影响有效的PUL分诊。
