Supply chain management and accessibility to point-of-care testing in resource-limited settings: a systematic scoping review

A study aimed at comparing healthcare workers experiences and challenges in scaling up from a highly supported non-Government Organization-led pilot to a large-scale ministry of health-led national programme in Zambia has shown that half of the piloted sites reported a stock-out on one occasion [51]. It was also shown that almost a third of rollout sites reported a complete stock-out of RSTs during the month preceding interviews [51]. Another study in Zambia that evaluated the impact of RST and treatment in pregnant women also reported stock-out of RSTs at various stages [47]. A total of 33.3% (2/6) of the facilities documented stock-outs during the baseline ranging from 8 to 20 weeks, 33% (5/15) during the midline period ranging from 4 to 12 weeks with a median stock-out period of 6 weeks; and 60% (9/15) during the end line period ranging from 1 to 16 weeks, with a median stock-out period of 5.5 weeks [47]. Peeling and Ronald (2009) further reported that RSTs stock-out was one of the causes of poor levels of syphilis testing among pregnant women in LMICs [54]. The findings showed weaknesses in the supply chain system such as procurement, inventory and stock management, and human resource capacity for SCM during implementation hence, resulted in significant RST stock-outs.

A substantial high levels of malaria RDTs stock-out was reported in Capo Delgado province in Mozambique [48]. This high levels of stock out was associated with poor test usage [48]. Estimated loss of consumption percentage for malaria RDTs were significantly high with a weighted average of 78% [48]. Increased rates of stock-outs were observed with increasing levels of consumption [48]. In a study aimed at assessing health system’s capacity to absorb Parasite based Malaria Diagnosis in Uganda has shown that, malaria RDTs were available only in 24% (30) out of the 125 lower level health facilities [45]. The study also reported limited availability of malaria RDTs, as well as lack of glucometers [45]. A survey aimed at assessing the quality and safety of having community health workers (CHWs) use RDTs and provide integrated management of malaria and pneumonia revealed 72.2% of CHWs did not receive malaria RDTs kits for 6 months [43].These findings demonstrate limited availability of malaria RDTs, stock out of malaria RDTs, and lack of glucometers in the study settings. The findings also demonstrate that further research is needed to determine the impact of malaria RDTs stock outs on patients’ outcomes in these settings.

A study conducted in rural antenatal clinic and community- based settings in Guatemala showed that nearly half of the women who turned up for HIV, syphilis, and hepatitis b virus testing services did not get tested partly due to stock-outs [44]. Another study has also demonstrated the prevalence of blood pressure monitoring devices, diabetes, and dyslipidaemia POC assays stock-outs in LMICs [55]. It was reported that manufacturers of new assays entering the market are most often unable to meet the demand of rapid recommendations [52]. A delayed response by Guava trained technicians resulted in Guava EasyCD4 downtimes of 8 out of 45 months, nearly 18% of the total available operating time was reported [50]. In addition, poor stock management resulted in expiration of Guava EasyCD4 since the shelf life was limited to 12 months from the time of production [50]. Shott et al. (2012) noted that, quality management systems of POC diagnostics can really transform the availability of tests in real time to inform proper patient care [53]. Jaya et al. (2017) study findings in primary healthcare clinics in rural KwaZulu-Natal in South Africa showed 4 out of eleven clinics reported past experiences of HIV rapid test kits shortage [46]. Three of the 4 clinics, informed patients when there was a shortage and asked them to return at a later date, whilst the fourth clinic referred the patients to neighbouring healthcare facilities [46]. A study aimed to highlight challenges faced in decentralizing POC testing showed that access to HIV testing can be challenging when the service is only available at the national level [56]. It also demonstrated that long turn-around time for release of test results accounted for a significant proportion of people failing to return for test results in LMICs [56]. These findings reveal stock-outs of HIV and HBV test kits, CD4 test, blood pressure monitoring devices, diabetes, and dyslipidaemia POC assays that requires further investigations to ascertain the supply chain management challenges for these diagnostics in LMICs.

This review revealed that POC test stock-outs mostly was due to poor quantification and forecasting, inventory management of POC diagnostic tests, and inadequate/lack of supervision during implementation [44, 51, 54]; inaccurate documentations and distribution systems [48, 57]; lack of storage space [45]; and poor commodity management [47]. The rest included: high cost and poor quality management systems [52, 53]; poor regulatory controls and limited guideline [52]; and inability of production line to meet global uptake [52]. Therefore, future studies are recommended in LMICs aiming at determining the impact of diagnostic test stock-outs and health outcomes especially for HIV, syphilis, and malaria test.

A research study conducted in Zambia showed increased syphilis testing during the early stages of RSTs introduction but subsequently dropped at the midline and end line [47]. It demonstrated increased syphilis testing from (140/1365, 10.6%) at the baseline to (976/1446, 67.5%) midline, and dropped to (752/1337, 56.3%) at the end line (P < 0.001) for both midline and end line compared with the baseline [47]. Mabey et al. (2012) study in Tanzania, Uganda, China, Peru and Zambia and Brazil has shown that more than 100,000 pregnant women were tested for syphilis in all the study site [49]. It also showed that in Brazil, healthcare workers exceeded the original set target (30–40%) in remote communities and succeeded in testing 55% of the sexually active population for syphilis [49]. Smith et al. (2015) indicated that, HIV and syphilis testing uptake by pregnant women was 50.3% HIV and 42.2% for HBV following the introduction of these tests in the antenatal clinic [44]. The study also reports corresponding increases for HIV and syphilis testing uptake as 143.9% (P < 0.001) and of 1.3% (P = 0.87) respectively [44]. In all, 51.3% (462/901) pregnant women were tested either at the health posts or by outreach teams and 48.7% (439/901) at the district healthcare center [44]. This finding indicates increased use and uptake of syphilis RSTs, HIV and HBV test though use of RSTs declined at some stages. This also demonstrates a gap in literature on the role of SCM for POC diagnostics use which requires further investigations to determine its effect on clients.

Thairu et al. (2011) focused on describing lessons learned in providing CD4 diagnostics in Burkina Faso and Zimbabwe [50]. The study reported that, a total of 3287 CD4 tests were performed for 1558 patients enrolled in the programme in Burkina Faso with an average of two tests per patient (range: 1~10) [50]. In all, 60% of the patients had only one test at the initial stage of the programme but the frequency of repeated tests within 12 months as recommended by national guidelines varied from 59% at the baseline to 16% [50]. A total of 8990 tests were done on 6024 patients in Zimbabwe with an average of one test per patient (range: 1~4) [50]. This outcome demonstrates declined repeated CD4 testing due to poor test stock out.