Background
Methods
Study site
Study design
Study procedures
Training of health workers
Enrollment of participants, data collection and patient protection
Malaria diagnosis
Sample size and power
Data analysis
Ethical approval
Results
RDT name | Bioline SD | First response malaria | ICT diagnostics | Paracheck | Total | P value* | |
---|---|---|---|---|---|---|---|
Health centre name | Mdeka (N = 476) | Lilangwe (N = 508) | Chileka (N = 683) | Bangwe (N = 573) | Mdeka (N = 333) | (N = 2,573) | |
Health facility characteristics | |||||||
Location | Rural | Rural | Semi-urban | Urban | Rural | ||
Person performing RDT | CHW‡ | CHW‡ | Laboratory Technician | Laboratory Technician | CHW‡ | ||
Patient characteristics | |||||||
Female | 59% | 60% | 59% | 56% | 65% | 59% | 0.13 |
Child 5-15 years old | 44% | 56% | 37% | 36% | 30% | 42% | < 0.001 |
Owns a mosquito net Used a mosquito net the previous night | 54% 50% | 62% 63% | 51% 48% | 43% 41% | 58% 61% | 53% 52% | < 0.001 < 0.001 |
Self treated with antimalarial in past 2 weeks | 8% | 5% | 29% | 8% | 2% | 12% | < 0.001 |
Presumptive malaria diagnosis | 100% | 99% | 27% | 92% | 100% | 89% | < 0.001 |
Local microscopy positive† | na | na | 69% | 29% | na | 51% | < 0.001 |
RDT positive | 76% | 72% | 53% | 25% | 66% | 56% | < 0.001 |
Expert microscopy positive | 41% | 40% | 16% | 3% | 34% | 25% | < 0.001 |
Sensitivity and specificity of malaria rapid diagnostic tests
Sensitivity n/N(%) | Unadjusted odds ratio (P value) | Adjusted odd ratio Model 1 (P value) | Adjusted odds ratio Model 2 (P value) | |
---|---|---|---|---|
RDT type | ||||
Bioline SD | 188/193 (97) | 2.6 (0.17) | 2.9 (0.14) | |
First response malaria | 185/201 (92) | 1.1 (0.82) | 1.1 (0.84) | |
Paracheck | 118/130 (91) | 0.8 (0.63) | 0.8 (0.77) | |
ICT diagnostics | 98/109 (90) | Referent | Referent | |
Age | ||||
5 to ≤ 15 yrs | 369/382 (97) | 4.8 (< 0.001) | 5.1 (< 0.001) | 5.1 (< 0.001) |
> 15 yrs | 206/237 (87) | Referent | Referent | Referent |
Temperature | ||||
≥ 37.5°C | 281/298 (94) | 2.1 (0.09) | 1.7 (0.23) | 1.7 (0.22) |
< 37.5°C | 286/310 (92) | Referent | Referent | Referent |
Geometric mean parasite density | ||||
≥ 5000 per μl | 181/193 (94) | 1.1 (0.74) | 0.7 (0.36) | 0.6 (0.32) |
< 5000 per μl | 408/440 (93) | Referent | Referent | Referent |
Self-treated with antimalarial in past 2 weeks | ||||
Yes | 44/51 (86) | 0.9 (0.85) | 1.2 (0.82) | 2.1 (0.38) |
No | 501/538 (93) | Referent | Referent | Referent |
RDT performed by: | ||||
Community health worker | 481/507 (95) | 2.6 (0.03) | 3.1 (0.02) | |
Laboratory technician | 108/126 (86) | Referent | Referent |
Specificity n/N(%) | Unadjusted odds ratio (P value) | Adjusted odd ratio Model 1 (P value) | Adjusted odds ratio Model 2 (P value) | |
---|---|---|---|---|
RDT type | ||||
Bioline SD | 109/283 (39) | 0.5 (< 0.001) | 0.5 (< 0.001) | |
First response malaria | 128/307 (42) | 0.6 (< 0.001) | 0.7 (0.01) | |
Paracheck | 530/776 (68) | 1.8 (< 0.001) | 2.1 (< 0.001) | |
ICT diagnostics | 311/574 (54) | Referent | Referent | |
Age | ||||
5 to ≤ 15 yrs | 278/680 (41) | 0.4 (< 0.001) | 0.4 (< 0.001) | 0.4 (< 0.001) |
> 15 yrs | 778/1211 (64) | Referent | Referent | Referent |
Temperature | ||||
≥37.5°C | 422/790 (53) | 0.8 (0.03) | 0.8 (0.02) | 0.9 (0.20) |
< 37.5°C | 640/1092 (59) | Referent | Referent | Referent |
Self-treated with antimalarial in past 2 weeks | ||||
Yes | 126/254 (50) | 0.7 (0.02) | 0.7 (0.05) | 0.5 (< 0.001) |
No | 920/1605 (57) | Referent | Referent | Referent |
RDT performed by: | ||||
Community health worker | 346/810 (43) | 0.4 (< 0.001) | 0.4 (< 0.001) | |
Laboratory technician | 732/1130 (65) | Referent | Referent |
Predictors of malaria rapid diagnostic test performance
Health worker adherence to malaria diagnostic test results and training instructions
Test results | Training instructions | Treated with anti-malarial n/N (%) |
---|---|---|
Sites with local microscopy | ||
Microscopy positive, RDT positive | Treat for malaria | 366/368 (99) |
Microscopy positive, RDT negative | Treat for malaria | 283/286 (99) |
Microscopy negative, RDT negative | Do not treat for malaria | 34/471 (7) |
Microscopy negative, RDT positive | Do not treat for malaria | 83/155 (54) |
Sites without local microscopy | ||
RDT positive | Treat for malaria | 985/1,005 (98) |
RDT negative | Do not treat for malaria | 223/385 (58) |