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

Author(s):  
Rachel C Dale ◽  
Loretta T Ford ◽  
Catherine Street

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.

2014 ◽  
Vol 14 (1) ◽  
Author(s):  
Han-Zhu Qian ◽  
Valerie J Mitchell ◽  
Sally Bebawy ◽  
Holly Cassell ◽  
Gina Perez ◽  
...  

Author(s):  
Steve George

AbstractThere is a continuing increase in the use of immunological techniques in the field of clinical toxicology. This is primarily due to the rapidity by which analytical results are now required, and can be obtained, following the testing of individuals for drug use. There has recently been an increase in the repertoire of assays now available to testing laboratories (e.g., buprenorphine and heroin metabolite assays), with the techniques themselves becoming increasingly more specific for the drugs and/or metabolites being monitored (e.g., methadone metabolite assays). The near patient testing (NPT), or point-of-care testing (POCT), devices are now several generations forward from their inception, with some tests now approaching the sensitivity and specificity of automated laboratory-based methods. This review has been collated from the literature to illustrate some of the possible reasons for the move towards the increasing use of immunological techniques, and to highlight some of the advantages and disadvantages associated with such drug screening methods. In particular, it has been shown that it is important to determine, monitor and review the knowledge and training of the individual using the technique. In addition, quality control and quality assessment are paramount to ensure the validity of any drug testing being performed. It has also been shown that it is vital to maintain and develop the relationships between the staff performing the testing, the laboratory (if the testing is performed using NPT devices), and the clinicians utilising the results obtained from drug testing. Without these links, interpretive errors could arise which could adversely affect the diagnosis and management of patients.


The Analyst ◽  
2019 ◽  
Vol 144 (4) ◽  
pp. 1034-1051 ◽  
Author(s):  
Fan Pu ◽  
Spencer Chiang ◽  
Wenpeng Zhang ◽  
Zheng Ouyang

Direct sampling mass spectrometry enables high-performance clinical analysis, such as imaging, drug monitoring and point-of-care testing.


Author(s):  
Shaun Ungaro ◽  
Francesca Wirth ◽  
Lilian M. Azzopardi ◽  
Anthony Serracino-Inglott

2021 ◽  
Vol 58 (S1) ◽  
pp. 18-18
Author(s):  
C. Kyriacou ◽  
S. Kapur ◽  
S. Jeyapala ◽  
S. Bobdiwala ◽  
H. Fourie ◽  
...  

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0253135
Author(s):  
Olga P. M. Saweri ◽  
Neha Batura ◽  
Rabiah Al Adawiyah ◽  
Louise M. Causer ◽  
William S. Pomat ◽  
...  

Background Sexually transmitted and genital infections in pregnancy are associated with adverse pregnancy and birth outcomes. Point-of-care tests for these infections facilitate testing and treatment in a single antenatal clinic visit and may reduce the risk of adverse outcomes. Successful implementation and scale-up depends on understanding comparative effectiveness of such programmes and their comparative costs and cost effectiveness. This systematic review synthesises and appraises evidence from economic evaluations of point-of-care testing and treatment for sexually transmitted and genital infections among pregnant women in low- and middle-income countries. Methods Medline, Embase and Web of Science databases were comprehensively searched using pre-determined criteria. Additional literature was identified by searching Google Scholar and the bibliographies of all included studies. Economic evaluations were eligible if they were set in low- and middle-income countries and assessed antenatal point-of-care testing and treatment for syphilis, chlamydia, gonorrhoea, trichomoniasis, and/or bacterial vaginosis. Studies were analysed using narrative synthesis. Methodological and reporting standards were assessed using two published checklists. Results Sixteen economic evaluations were included in this review; ten based in Africa, three in Latin and South America and three were cross-continent comparisons. Fifteen studies assessed point-of-care testing and treatment for syphilis, while one evaluated chlamydia. Key drivers of cost and cost-effectiveness included disease prevalence; test, treatment, and staff costs; test sensitivity and specificity; and screening and treatment coverage. All studies met 75% or more of the criteria of the Drummond Checklist and 60% of the Consolidated Health Economics Evaluation Reporting Standards. Conclusions Generally, point-of-care testing and treatment was cost-effective compared to no screening, syndromic management, and laboratory-based testing. Future economic evaluations should consider other common infections, and their lifetime impact on mothers and babies. Complementary affordability and equity analyses would strengthen the case for greater investment in antenatal point-of-care testing and treatment for sexually transmitted and genital infections.


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