Abstract
BackgroundExternal quality assurance (EQA) programmes, which are routinely used in laboratories, have not been widely implemented for point-of- care tests (POCTs). A study was performed in ten health centres in Tanzania, to implement the use of dried blood spots (DBS) as an EQA method for HIV and syphilis (POCTs).MethodDBS samples were collected for retesting at a reference laboratory and the results compared to the POCT results obtained at the clinic. In total, 2341 DBS samples were collected from 10 rural health facilities over a period of nine months, of which 92.5% were correctly collected and spotted.ResultsThe EQA method was easily implemented by healthcare workers under routine conditions in Northern Tanzania. For HIV, 967 out of 972 samples (99.5%) were concordant between DBS and POCT results. For syphilis, the sensitivity of syphilis tests varied between clinics with a median of 96% (25th and 75th quartile; 95-98%). The specificity of syphilis POCT was consistent compared to laboratory based test using DBS, with a median of 96% (25th and 75th quartiles; 95-98%).ConclusionOverall, the quality of testing varied at clinics and EQA results can be used to identify clinics where healthcare workers require remedial training, suggesting the necessity for stringent quality assurance programmes for POC testing. As Tanzania embarks on scaling up HIV and syphilis testing, DBS can be a useful and robust tool to monitor the quality of testing performed by healthcare workers and trigger corrective action to ensure accuracy of test results.
Highlights
External quality assurance (EQA) programmes, which are routinely used in laboratories, have not been widely implemented for point-of- care tests (POCTs)
dried blood spots (DBS) as EQA method To evaluate the implementation of the EQA method across the ten antenatal care clinics (ANC), the quality of DBS samples was reviewed
Out of the 2201 samples included in this study, 972 (44.1%) had recorded HIV test results and 966 (99.5%) were concordant between POCT and DBS
Summary
External quality assurance (EQA) programmes, which are routinely used in laboratories, have not been widely implemented for point-of- care tests (POCTs). A study was performed in ten health centres in Tanzania, to implement the use of dried blood spots (DBS) as an EQA method for HIV and syphilis (POCTs). Point-of-care diagnostic tests (POCTs) are increasingly used in both developing and developed countries [1]. They allow same day testing and treatment at remote locations where no laboratory support is available. In Tanzania, the Ministry of Health currently recommends the use of POCTs to screen pregnant women for HIV and syphilis, but an External quality assurance (EQA) method has not been implemented [3]. Dried blood spots (DBS) have been suggested as a potential method for QA for HIV POCT [6], but this has not been implemented under routine testing services
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