Background
Methods
Study design
Blood sample collection
Ethical clearance
Standard microscopy evaluation
CareStart™ malaria kit assessment
CareStart™ malaria test procedures
Test detection and validation
Plasmodium species identification
Data analysis
Results
General characteristics of patients
Total | 241 | |
---|---|---|
Mean age (range) (years) | 29.62 ± 11.21 (3–58) | |
Age group (%) | ≤5 years old | 4 (1.66%) |
5–18 years old | 22 (9.13%) | |
>18 years old | 215 (89.21%) | |
Gender (%) | Male | 188 (78.01%) |
Female | 53 (21.99%) | |
Geometric mean parasite density (range)/μl | 5,990 (48~377143)/μl | |
Parasite density distribution | <100/μl | 4 (3.18)% |
100 ~ 1,000/μl | 15 (11.90%) | |
>1,000/μl | 107 (84.92%) |
Comparison of CareStart™ kit, standard microscopy and polymerase chain reaction results
CS RDT kit | Microscopy | PCR | ||
---|---|---|---|---|
Positive | Negative | Positive | Negative | |
Positive | 113 | 2 | 115 | 0 |
Negative | 13 | 113 | 13 | 113 |
Sensitivity (95% IC)% | 89.68 (83.15, 93.87 ) | 89.84 (83.4, 93.97 ) | ||
Specificity (95% IC)% | 98.26 (93.88, 99.52 ) | 100 (96.71, 100 ) | ||
Positive Predictive Value (95% IC)% | 98.26 (93.88, 99.52 ) | 100 (96.77, 100 ) | ||
Negative Predictive Value (95% IC)% | 89.68 (83.15, 93.87 ) | 89.68 (83.15, 93.87 ) | ||
Diagnostic Accuracy | 93.78 (89.99, 96.19 ) | 94.61 (90.99, 96.82 ) | ||
Likelihood ratio of a Positive Test | 51.57 (19.32 – 137.7) | - | ||
Likelihood ratio of a Negative Test | 0.11 (0.09, 0.12) | 0.1 (0.09 0.12) | ||
Diagnostic Odds | 491.1 (108.3 – 2226) | - | ||
Cohen’s kappa (Unweighted) | 0.88 (0.75 – 1.00) | 0.89 (0.77, 1.02) | ||
Entropy reduction after a Positive Test% | 60.44 | - | ||
Entropy reduction after a Negative Test% | 36.01 | 35.92 | ||
Bias Index | −0.04 | −0.05 |
CareStart™ malaria test results
CS Diagnostic Kit | Microscopy | PCR | ||||||
---|---|---|---|---|---|---|---|---|
P. falciparum*
|
P. vivax
|
P. falciparum*
| P.vivax | |||||
Positive | Negative | Positive | Negative | Positive | Negative | Positive | Negative | |
Positive | 54 | 2 | 59 | 0 | 56 | 0 | 59 | 0 |
Negative | 7 | 113 | 6 | 115 | 7 | 113 | 6 | 113 |
Sensitivity (95% IC)% | 88.52 (78.16, 94.33) | 90.77 (81.29, 95.7) | 88.89 (78.8, 94.51) | 90.77 (81.29, 95.7) | ||||
Specificity (95% IC)% | 98.26 (93.88, 99.52) | 100 (96.77, 100) | 100 (96.71, 100) | 100 (96.71, 100) | ||||
Positive Predictive Value (95% IC)% | 96.43 (87.88, 99.02) | 100 (93.89, 100) | 100 (93.58, 100) | 100 (93.89, 100) | ||||
Negative Predictive Value (95% IC)% | 94.17 (88.45, 97.15) | 95.04 (89.6, 97.71) | 94.17 (88.45, 97.15) | 94.96 (89.44, 97.67) | ||||
Diagnostic Accuracy (95% IC)% | 94.89 (90.57, 97.29) | 96.67 (92.92, 98.46) | 96.02 (92.02, 98.06) | 96.63 (92.84, 98.45) | ||||
Cohen’s kappa (Unweighted) | 0.89 (0.74, 1.03) | 0.93 (0.78,1.07) | 0.91 (0.76, 1.06) | 0.93 (0.78, 1.07) |