Table 2

Main characteristics and performance results of the field-tested devices

Name of the device (developer)Field test location(s)Therapeutic indication testedReported sensitivityReported specificityOther 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.
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.