Are point-of-care urine drug testing devices suitable for antenatal drug screening? A study verifying the Alere® Drug Screen Test Cup for the detection of six classes of drug in a pregnant population

Ann Clin Biochem. 2021 May;58(3):166-173. doi: 10.1177/0004563221990699. Epub 2021 Feb 1.

Abstract

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 testing to detect illicit drug use in pregnancy. To determine the suitability of this approach, we have compared the results of urine analysis by point-of-care testing with another NHS specialist clinical toxicology service that uses confirmation mass spectrometry.

Methods: A total of 482 anonymized 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 point-of-care screening, 4.4% tested positive: 19 opiate and 2 cocaine. Concordance between point-of-care 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 point-of-care devices to detect drug use in pregnancy are that is convenient and cheap. However, the clinical utility of point-of-care 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.

Keywords: Pregnancy; drugs of abuse screening; point of care.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amphetamine / urine
  • Benzodiazepines / urine
  • Buprenorphine / urine
  • Chromatography, Liquid
  • Cocaine / urine
  • Female
  • Gas Chromatography-Mass Spectrometry
  • Humans
  • Illicit Drugs / urine
  • Methadone / urine
  • Narcotics / urine
  • Opiate Alkaloids / urine
  • Point-of-Care Testing*
  • Pregnancy
  • Substance Abuse Detection / methods*
  • Substance-Related Disorders / diagnosis
  • Substance-Related Disorders / urine*
  • Tandem Mass Spectrometry
  • Urinalysis / methods*

Substances

  • Illicit Drugs
  • Narcotics
  • Opiate Alkaloids
  • Benzodiazepines
  • Buprenorphine
  • Amphetamine
  • Cocaine
  • Methadone