Background: Currently there are no national guidelines for antenatal drug testing. At Colchester Hospital we use a strategy of screen-only using point of care (POC) testing to detect illicit drug use in pregnancy. To determine the suitability of this approach we have compared results of urine analysis by POC testing with another NHS specialist clinical toxicology service that uses confirmation mass spectrometry.

Methods: 482 anonymised random urine specimens from antenatal clinics were tested for six drug classes: amphetamine, benzodiazepines, buprenorphine, cocaine, methadone and opiates using the Alere™ Drug Screen Urine Test Cup. The manufacturer’s claims for positive cut off and result stability were verified using spiked blank urine. Confirmatory testing was performed using ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) for detection of 26 individual drugs.

Results: Of 473 urine samples with adequate volume for POC screening, (4.4%) tested positive; 19 opiate and 2 cocaine. Concordance between POC screening and UPLC-MS/MS confirmation was 97.9% for all drugs and 78.9 % for opiates. Using spiked urine, only positive results for opiates were stable when read up to the manufacturer’s recommended time of 60 min.

Conclusions: The key advantages of using POC devices to detect drug use in pregnancy are that is convenient and cheap. However, the clinical utility of POC testing is limited by its poor sensitivity. Best practice is to confirm results using a more specific and sensitive method. As a result of this study we are now reviewing our own procedures to consider introducing routine confirmation by mass spectrometry.

背景：目前尚无用于产前药物测试的国家指南。在科尔切斯特医院，我们采用仅进行筛查的策略，即使用即时护理（POC）测试来检测怀孕期间的非法药物使用情况。为了确定这种方法的适用性，我们将POC测试的尿液分析结果与另一家使用确认质谱的NHS专业临床毒理学服务进行了比较。

方法：使用Alere™药物筛查尿杯，对来自产前诊所的482例匿名随机尿标本进行了六个药物类别的测试：苯丙胺，苯并二氮杂卓，丁丙诺啡，可卡因，美沙酮和鸦片剂。使用加标的空白尿液可验证制造商声称的阳性截止值和结果稳定性。使用超高效液相色谱串联质谱法（UPLC-MS / MS）进行了确认性测试，以检测26种药物。

结果：在473份具有足够POC筛查能力的尿液样本中，（4.4％）测试呈阳性；19鸦片和2可卡因。所有药物的POC筛查与UPLC-MS / MS确认之间的一致性为97.9％，鸦片制剂为78.9％。使用加标的尿液，直到制造商建议的60分钟建议时间，鸦片制剂的阳性结果才稳定。

结论：在怀孕期间使用POC设备检测药物使用的主要优点是方便且便宜。但是，POC检测的临床实用性受到其敏感性差的限制。最佳实践是使用更具体，更敏感的方法来确认结果。这项研究的结果是，我们现在正在审查我们自己的程序，以考虑采用质谱法进行常规确认。