Main characteristics and performance results of the field-tested devices
| Name of the device (developer) | Field test location(s) | Therapeutic indication tested | Reported sensitivity | Reported specificity | Other information and user skill level required |
| GPHF-Minilab (Global Pharma Health Fund EV) | Gabon, Angola, Brazil, Cameroon, China, Democratic Republic of Congo, Egypt, Ethiopia, Ghana, India, Kenya, Nigeria, Russia, Rwanda, Thailand, Turkey, Uganda, Tanzania, Zambia, Bolivia, Brazil, Colombia, Ecuador, Guyana, Suriname, Venezuela. | Antimalarials15 46 47 92; antibiotics.92 | 29% of extremely non-compliant samples*† for both content and dissolution correctly identified by the Minilab47; Se‡ for both ID test and content test=79%, Se‡ for ID test only=100%.15 | Sp‡ for both ID test and content test=100%, Sp‡ for ID test only=100%.15 | Visual appearance did not provide consistent results when performed by MRA staff or lab staff.47 Some lab skills required—at least 1-week training and proficiency testing recommended. |
| CD3/CD3+ (US FDA) | Ghana. | Antimalarials.15 | Se‡=100% for analysis based on packaging materials and dosage unit,15 Se‡=100% for dosage unit-only analysis.15 | Sp‡=53% for analysis based on packaging materials and dosage unit,15 Sp†‡=64% for analysis dosage unit-only analysis.15 | More reliable to conduct side-by-side comparisons with physical authentic samples than using the library images CDAIL.15 Low skill level required—performances increase with experience. |
| Lateral flow dipstick immunoassay (Unnamed) | Colombia, India, Papua New Guinea, Zambia. | Antimalarials.51 | NA—no gold standard reported.51 NB: 2%–4% cross-reactivity of artemether and artesunate to artemisinin.51 | NA—no gold standard reported.51 | NA—no gold standard reported.51 Low skill level required. |
| TruScan RM (Thermo Scientific) | USA. | Erectile dysfunction drug.19 | Testing by unknown number of special agents unfamiliar with instrument and procedure: Acc§ for identification of the presence/absence of sildenafil (n=14)= 91.7%.19 | A sample preparation (extraction, filtration, addition of silver colloid) was performed, the obtained sample solution was then tested in a phial.19 Training of 20 min considered as sufficient (test by four analysts only).19 | |
| CBEx (Metrohm Raman) | India, Zimbabwe. | Antimalarials, antibiotics and others (not detailed in the publication).42 | NA.¶ | Rugged (instrument dropped accidentally twice with no observed altered functioning; no problem during routine international air transportation and travel by vehicle to various sites; instrument withstood temperatures between room and 40°C temperatures.42 Less than 2 weeks training estimated as sufficient to become basic to advanced user.42 | |
| Speedy Breedy (Bactest) | India, Zimbabwe. | Antibiotics, sterile sodium chloride, purified water.71 | NA.¶ | Long time run=power interruption required to restart the run of the sample the next day; biological waste management required; carry case not robust enough at the time of study.71 Less than 2 weeks training estimated as sufficient to become basic to advanced user.71 | |
*Extreme deviation was defined as a deviation of 20% or more from the declared amount of API as determined by assay, and/or a percentage of active ingredient dissolved 25% or more below the pharmacopoeial limit Q in dissolution testing.
†Against HPLC and dissolution testing (please note that disintegration testing is not an appropriate proxy for dissolution testing).
‡Against HPLC analysis.
§Against FT-IR
¶Field evaluation aimed at testing the field utility of the device rather than its performance.
Acc, Accuracy: API, active pharmaceutical ingredient; CDAIL, CD3 Authentic Image Library ; HPLC, high-performance liquid chromatography; ID, Identification; MRA, medicines regulatory authority; NA, not available; Se, sensitivity; Sp, specificity.