Table 1 Study information and characteristics
From: Point-of-care testing in private pharmacy and drug retail settings: a narrative review
Ref no | First author | Country | Year performed | Year published | Length of study (months) | Type of study | Name of POCT | Targeted disease | Targeted pathogen or antibody | Patient sample used for test |
|---|---|---|---|---|---|---|---|---|---|---|
[23] | Ansah | Ghana | 2011 to 2013 | 2015 | 18 | Clustered randomized (RCT) | CareStart Malaria HRP2 Pf | Malaria | Plasmodium falciparum | Blood |
[35] | Audu | Ghana | 2014 | 2016 | 6 | Prospective cross-over study | Blue Aid Malaria Test Kit | Malaria | P. falciparum, Plasmodium vivax | Blood |
[36] | Aung | Myanmar | 2013 | 2015 | 6 | Clustered randomized (RCT) | Malaria POCT (unnamed) | Malaria | P. falciparum | Blood |
[24] | Awor | Uganda | 2011 to 2012 | 2014 | 13 | Controlled but non-randomised study | Malaria POCT (unnamed) and respiratory timers | Malaria and pneumonia | NA | Malaria: blood Pneumonia: breathing rate |
[37] | Awor | Uganda | 2011 to 2012 | 2015 | 13 | Controlled but non-randomised study | Malaria POCT (unnamed) and respiratory timers | Malaria and pneumonia | NA | Malaria: blood Pneumonia: breathing rate |
[38] | Cohen | Uganda | 2011–2012 | 2012 | 13 | Interventional study without controls | Care Start Malaria HRP2 Pf | Malaria | P. falciparum | Blood |
[26] | Hansen | Uganda | 2011 | 2017 | 12 | Cost effectiveness analysis of an RCT (see Mboyne et al.) | Care Start Malaria HRP2 Pf | Malaria | P. falciparum | Blood |
[39] | Hutchinson | Uganda | 2010 to 2012 | 2015 | 22 | Clustered randomized (RCT) | Malaria POCT (unnamed) | Malaria | NA | Blood |
[40] | Hutchinson | Uganda | 2010 to 2012 | 2017 | 22 | Clustered randomized (RCT) | Malaria POCT (unnamed) | Malaria | NA | Blood |
[41] | Ikwuobe | Nigeria | 2012 | 2013 | 3 | Controlled but non-randomised study | SD BIOLINE Malaria Antigen Pf | Malaria | P. falciparum | Blood |
[42] | Kitutu | Uganda | 2013 to 2015 | 2017 | 16 | Controlled but non-randomised study | Care Start Malaria HRP2 Pf and respiratory timers | Malaria, pneumonia and bloody diarrhoea | P. falciparum | Malaria: blood Pneumonia: breathing rate |
[43] | Kwarteng | Ghana | 2013 | 2019 | 8 | Interventional study without controls | Care Start Malraria HRP2 Pf | Malaria | P. falciparum | Blood |
[44] | Maloney | Tanzania | 2013 to 2014 | 2017 | 15 | Clustered randomized (RCT) | ParaHIT Ag Pf POCTs | Malaria | P. falciparum | Blood |
[34] | Mbonye | Uganda | 2011 | 2015 | 12 | Clustered randomized (RCT) | Malaria POCT (unnamed) | Malaria | NA | Blood |
[33] | Mbonye | Uganda | 2011 | 2015 | See Mboyne 2015 | Policy analysis of Mboyne (2015) | ||||
[45] | Onwunduba | Nigeria | 2022 | 2023 | 6 | Cluster randomized trial (RCT) | CRP test kit from Zhuhai Encode Medical Engineering Co | Respiratory tract infections (RTI) | Viruses or bacteria causing RTIs | Blood |
[46] | O' Meara | Kenya | 2014–2015 | 2016 | 11 | Factorial randomized (RCT) | Malaria POCT (unnamed) | Malaria | NA | Blood |
[47] | Poyer | Kenya | 2013–2016 | 2018 | 18 | Interventional pre-post study | CareStart Malaria HRP2 (Pf) | Malaria | P. falciparum | Blood |
[48] | Shelus | Uganda | 2021 | 2023 | 3 months | Uncontrolled interventional trial | 8 types of RDTs, most frequently: SD Bioline, SD Biosensor, Carestart, and First Response | Malaria | P. falciparum | Blood |
[49] | Simmalavong | Laos | 2008–2016 | 2017 | 108 | Interventional study without controls | Malaria POCT (unnamed) | Malaria | NA | Blood |
[50] | Soniran | Ghana | 2019–2020 | 2022 | 14 | Cluster randomized trial (RCT) | Malaria POCT (unnamed) | Malaria | NA | Blood |
[51] | Sudhinaraset | Myanmar | 2013 | 2015 | 6 | Qualitative study of RCT | FIRST RESPONSER Malaria antigen pLDH/HRP2 combo card test | Malaria | NA | Blood |
[52] | Thet | Myanmar | 2019–2020 | 2021 | 3 | Interventional study without controls | Malaria POCT (unnamed) | Malaria | P. falciparum | Blood |
Ref no | Urban/Rural | Type and number of outlets included in study groups | Description of clientele served by private stores selling POCT included in study | Sharp box and/or gloves provided? | Length and content of provider training | Guidelines for patients that test positive | Guidelines for patients that test negative | Supervision frequency and method of private providers of POCT | Demand generation activities | Recommended retail price of POCT |
|---|---|---|---|---|---|---|---|---|---|---|
[23] | Rural | 24 communities with 1 to 5 chemical shops per community | Clients with fever or who requested antimalarials, who were not pregnant, > 6 months old, no severe disease, no prescription from health facility, in district for > = 28 days | Bins for disposal of sharps, reference charts for doses of artemisinin therapy | 3 days on Ghana’s antimalarials policy, symptoms, indications for referral, blood sampling, blood safety, sharps usage, infection prevention, study protocol Intervention arm: extra 1 day, how to perform, interpret and manage negative POCTs, practise sessions | Encourage clients to purchase ACTs | Refer to nearby healthy facility or facility of choice | Recorded by seller on customised form which was subject to random checks by study authors; mystery clients | Community sensitization meetings and durbars (traditional community leaders) | NA |
[35] | Mixed | 6 private retail pharmacies in 3 different districts of the Ashanti region | 1200 patients with fever or history of fever in past 48 h | No | Technique and usage of POCT | NA | NA | Recorded by pharmacy on reporting form, which was studied daily by principal researcher; Microscopy to confirm diagnoses | NA | NA |
[36] | Rural | 171 general retail stores, drug vendors, medical drug representatives | Households who had fever in last 3 weeks and taken antimalarials or had malaria symptoms, lived in an area where ACT was sold in private sectors | Antiseptic pad provided | Use, interpretation and safe disposal of POCT | Prescribe ACT | Refer to nearest health facilities | Arm 1: Monthly check-in visit, Arm 3: Bi-monthly intensive support visits with one-on-one discussions, information, education and communication | NA | Price subsidy for POCT resupply at $0.18/test |
[24] | Rural | Intervention: 44 registered drug shops Control: 40 registered drug shops | Caretakers and children (< 5y/o and febrile) who sought care in drug shop or lived in participating districts | No | 5 days of 2 drug shop attendants per drug shop on how to use POCT for fevers and respiratory timer for coughs, dispense pre-packaged drugs, via clinical sessions | Dispense recommended treatment of ACTs (malaria) and amoxicillin (pneumonia) | NA | Direct observation by field supervisor (nurse) | Branding of drug shops, communicating with caretakers of children, information on care-seeking provided at markets, public gatherings and radios | Free POCTs; Subsidised drugs: ACTs, amoxicillin, oral rehydration solution, zinc sulfate at 50–80% mark-up, selling at USD 0.38 |
[37] | Rural | Intervention: 44 registered drug shops Control: 40 registered drug shops | Caretakers and children (< 5y/o and febrile) who sought care in drug shop or lived in participating districts | No | 5 days of 2 drug shop attendants per drug shop on how to use POCT for fevers and respiratory timer for coughs, dispense pre-packaged drugs, via clinical sessions | Dispense recommended treatment of ACTs (malaria) and amoxicillin (pneumonia) | NA | Direct observation by field supervisor (nurse) | Branding of drug shops, communicating with caretakers of children, information on care-seeking provided at markets, public gatherings and radios | Free POCTs; Subsidised drugs: ACTs, amoxicillin, oral rehydration solution, zinc sulfate at 50–80% mark-up, selling at USD 0.38 |
[38] | Mainly rural | 92 drug shops in 58 villages that offered POCTs after completing training and households in the selected villages | Households in 67 villages with at least 1 pharmacy | Gloves and sharps disposal box provided | 2 days (adapted from a WHO-based organization) on POCT, administration procedures, results interpretation | No specific instruction was provided other than proceed as usual | No specific instruction was provided other than proceed as usual | Monthly monitoring visit with administrative record checks from wholesale distributors | NA | Shops bought it from wholesalers at an agreed US 0.20 and sold at shop’s discretion |
[26] | Mainly rural | 20 randomized clusters, with10 for each intervention arm | Population with a majority living in rural areas/farmers seeking care for fever | No | 3 days on malaria case management, 1 extra day for intervention arm on POCT | Recommend ACT purchase | No ACT or other anti-malarials would be sold | Close support visit for first 3 months, lessened after | Community sensitization programs | POCTs provided to drug shops for free. Recommended retail price was $0.20 |
[39] | NA | Registered drug shop vendors, residents in area around drug shop who were clients or cared for clients, health workers in area | Participants who had been to the drug shop or cared for someone who had been | Blood slides and slide box, gloves, lancets, swabs and cotton wool provided | Both arms: 3 days on malaria, taking blood samples Intervention arm: 1 more day on POCTs | NA | NA | 2 months of supervision of at least 3 supervisory visits; scaled back later with periodic contact; one more visit at 12 months | Roadside sign advertising POCT availability | Free |
[40] | NA | 59 registered drug shops | Participants who had been to the drug shop or cared for someone who had been | Blood slides and slide box, gloves, lancets, swabs and cotton wool provided | Both arms: 3 days on malaria, taking blood samples Intervention arm: 1 more day on POCTs | NA | NA | 2 months of supervision of at least 3 supervisory visits; scaled back later with periodic contact; one more visit at 12 months | Roadside sign advertising POCT availability; community sensitization through Village Health Teams | Given for free and asked to sell at 0.20 USD |
[41] | Suburban | Intervention: 1 pharmacy with sufficient anti-malarial sales per day (> = 23 per day) Control: 1 pharmacy | Patients with symptoms of malaria seeking malaria treatment (with an anti-malarial prescription or wanting to self-medicate with them) | No | How to conduct POCTs | Permit purchase of antimalarial | Pharmacist and patient would discuss to suspend anti-malarial treatment | NA | NA | NA |
[42] | Mixed—Rural (6), Suburban (12), Urban (14 stores) | Intervention: 61 drug shops Control: 23 drug shops | Care seekers for children (< 5 y/o) with symptoms | No | Provision of information on workflow, information/education, communication on malaria, pneumonia, non-bloody diarrhoea treatments | Provide ACT (malaria) or amoxicillin DT (pneumonia) | Further evaluation and referral | Monthly supervision by supervisor trained in medicine, may be accompanied by district drug inspector and educator | Marking of intervention drug shops with posters, community sensitization campaign via radio talks | Free |
[43] | Rural | 3 pharmacy shops, 68 licensed chemical shops | Clients with fever or malaria signs/symptoms without signs of severe malaria | Gloves, disposal bins provided | 1 week workshop on malaria treatment, POCT administration and counselling of results | Dispense ACT | Symptomatic treatment, return advice, withhold ACT | Bimonthly supervisory visits | NA | Free to drug shops. No recommended retail price |
[44] | Rural | Intervention: 1 subsidised districts with 147 accredited drug dispensing outlets (ADDOs), 1 unsubsidised district with 115 ADDOs Control: 1 district | 18 y/o customers seeking treatment for fever, suspected malaria, or trying to purchase anti-malarial | Gloves, sharps box provided | Six two-day trainings on recognising malaria, use of POCTs, and treatment | Prescribe ACT based on Artemether and lumefantrine treatment based on provided dosing reference chart | Referral of severely ill patients to nearest public health facility | Quarterly monitoring visits, during which dispenser was observed directly by study staff and shop conditions were evaluated | Storefront sign advertising malaria testing | Non-subsidised: 0.67 USD, Subsidised: < = 0.32 USD |
[34] | Urban and periurban | 59 drug shops | Febrile patients seeking treatment at drug shops | No | 3 days for general malaria-related training Intervention arm: 1 extra day for POCT usage, blood slices preparation with extra training on communication skills to explain POCT diagnostics | Prescribe ACT | POCT-negative cases with fever: consider referral, no ACT/antimalarials would be sold | 2-month period of supervision with at least 3 supervisory visits, 12-month follow-up | Signs placed outside for advertisement, community sensitization programs prior to trial | POCTs provided for free. Priced at $0.20 |
[33] | ||||||||||
[45] | Urban | 20 private community pharmacies (10 intervention, 10 control) | Simulated clients who were trained to visit the pharmacy and complain of particular RTI symptoms | NA | Length was not described Training on use of CRP test kits and distinguishing viral and bacterial etiologies based on test kits | Advised not to dispense antibiotics to those with CRP < 30 mg/l, to use clinial judgments for CRP levels 30 ≤ CRP < 100 mg/l, dispense antibiotics if CRP ≥ 100 mg/l, but not discouraged from using professional judgement regardless of CRP results | Mystery clients visiting the pharmacies and presenting with RTI-like symptoms | NA | RDTs were provided and pharmacies were asked to charge < 1 USD per test | |
[46] | Rural | 11 medicine shops | Any individual < 1 years old with malaria-like illness or symptoms during past 24 h | No | 3 days on how to perform POCT | NA | NA | Field visits 1 week after enrolment of patients | NA | Yes, either free or $0.50 depending on group |
[47] | Mixed | 317 outlets (142 private health facilities and 175 pharmacies) | Adults seeking treatment for fever for themselves or on behalf of someone else | Gloves and sharps box provided | Training on malaria epidemiology, POCT procedure, case management for positive and negative test results | Prescribe ACT | Private health facilities—further investigatino, pharmacies—referral to health facility | routine supportive supervision visits | Radio, printed materials, small group sessions to highlight that not all fevers are malaria | 0.80 USD for POCT from hospital pack, 1 USD for POCT single pack |
[48] | Rural | 46 drug shops in 20 villages | Clients visiting participating drug shops reporting fever or purchasing antimalarials for themselves or other individuals | Not specified but given "materials to safely collect blood samples and dispose of waste" | 90 min training on study and RDT procedures | NA | Na | NA | NA | NA |
[49] | Urban | 317 pharmacies, 30 clinics | NA | NA | NA | NA | NA | NA | NA | NA |
[50] | Rural | 12 over-the-counter medicine sellers (7 intervention, 5 control) | Children under 10 years old with fever or suspected malaria in nearby households | NA | 2 day training on malaria management, treatment and follow-up | Provide ACT | NA | Quarterly supportive visitis during which skills from training were reinforced and technical guidance was provided | Community health workers and town criers engaged to carry out sensitization on malaria highlighting the imporance of malaria testing before treatment at religious venues and community durbars | 0.44 USD |
[51] | Rural | 30 informal providers | NA | NA | NA | NA | NA | NA | NA | NA |
[52] | Urban | 80 malaria drug shops for quantitative, 65 of these for qualitative interviews | Patients who were febrile and seeking care and drug shops | No | 1 day on use of POCT, national guidelines on treatment, stock and waste management, counselling, reporting to national centres | “Effective and quality” antimalarial drugs | Antipyretics, analgesics, medicines, but not antibiotics | NA | NA | NA |