Performance of a High-Sensitivity Rapid Diagnostic Test for Plasmodium falciparum Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naïve Human Challenge Infections

Although laboratory assays are more sensitive than microscopy and RDTs, they are also more expensive, require highly trained personnel, take longer to produce results, and are more difficult to deploy for large-scale field use. An Alere^™ Malaria Ag P.f Ultra Sensitive RDT (hsRDT) was developed for field use and evaluated for detection of low-density infections. Compared with the current commercial HRP2-based SD BIOLINE Malaria Ag P.f. RDT (RDT), the hsRDT uses the same immunochromatographic cassette platform, has the same whole blood volume requirements (5 µL), and takes only 5 minutes longer to result, making this device a promising and highly sensitive field tool.

A quantitative reverse transcription PCR (qRT-PCR) and a highly sensitive enzyme-linked immunosorbent assay (ELISA) test for histidine-rich protein II (HRP2) were used as reference assays.

Inclusion criteria: no fever history in the previous 7 days, axillary temperature less than 37.5°C, absence of other clinical signs of malaria, and no malaria treatment within the previous 60 days.

Population sample size: n= 607 from 100 selected random households to recruit children 6 months to 11 years old (Uganda), n=493 from visited households to recruit children and adults as part of an ongoing study to assess mass drug administration for malaria elimination (Myanmar), n=93 whole blood specimens from 16 human volunteers.

• Household survey (Uganda, Myanmar)
• Pf challenge human malaria infection study (Australia) 
• Outcome measures:
  • (Individual level) Parasite densities; HRP2 concentration; Diagnostic accuracy (sensitivity, specificity, negative predictive value, positive predictive value)
• Gold standard: qRT-PCR, ELISA
• Comparators: qPCR, qRT-PCR, RDT, ELISA
• Population selection criteria: No fever history in the previous 7 days, axillary temperature less than 37.5°C, absence of other clinical signs of malaria, and no malaria treatment within the previous 60 days.
• Population sample size: 
  • n= 607 from 100 selected random households to recruit children 6 months to 11 years old (Uganda)
  • n=493 from visited households to recruit children and adults as part of an ongoing study to assess mass drug administration for malaria elimination (Myanmar)
  • n=93 whole blood specimens from 16 human volunteers

Asymptomatic Reservoir
Diagnostics

Jan 2015 — Dec 2017

Australia
Myanmar
Uganda

DIAMETER: Diagnostics for Malaria Elimination Toward Eradication

Highly sensitive point-of-care diagnostics for P. falciparum