Table 2.
Tests Used and Their Reported Performance
| Pathogen | Type of Test | Test Name and Manufacturer | Test Performance by Manufacturer and Independent Studies |
|---|---|---|---|
| Streptococcus pyogenes (Group A streptococci) | Lateral flow RDT: detects Group A streptococcal antigen from throat swabs | OSOM Strep A, Sekisui Diagnostics | Sensitivity 96%; specificity 98% (vs culture; from Manufacturer) [18] Sensitivity 98%; specificity 99% (vs culture) [19] Sensitivity 86% (83.3–87.6); specificity 95% (94.5–96.2) [20] |
| Streptococcus pneumoniae | Lateral flow RDT: detects S. pneumoniae antigen in the urine of patients with pneumococcal pneumonia | BinaxNOW™ Streptococcus pneumoniae antigen card, Abbott/Alere | Sensitivity 86%; specificity 94% (from Manufacturer; urine test) [21] Sensitivity 74%; specificity 97% (from retrospective data) [22] |
| Influenza virus | Lateral flow RDT: detects influenza virus type A, type B and A (H1N1) pandemic antigens directly from nasal/throat/nasopharyngeal swab or nasal/nasopharyngeal aspirate | SD Bioline influenza Ag A/B/A(H1N1) PANDEMIC, Abbott/Alere | Sensitivity/specificity not available not available from Manufacturer [23] Sensitivity 56%; specificity 100% (vs RT-PCR) [24] |
| RSV | Lateral flow RDT: detects respiratory syncytial virus fusion protein antigen in nasal wash and nasopharyngeal swab specimens | Alere BinaxNOW® RSV Card, Abbott | Sensitivity 93%; specificity 93% (from Manufacturer; prospective NP swab); sensitivity 89%; specificity 100% (retrospective nasal wash) [25] Sensitivity 81%; specificity 93% (vs culture) [26] |
| Salmonella enterica serovar Typhi | Lateral flow RDT: detects Salmonella typhi-specific IgM from serum or whole blood | Test-it™ Typhoid IgM lateral flow assay, Life Assay Diagnostics Pty Ltd | Sensitivity/specificity by Manufacturer (not available) [27] Sensitivity 69% (95% CI: 59%–78%) for age >1 y old; specificity 90% (95% CI: 78%–93%) [28] |
| Denguea | Immunochromatographic assay | SD Bioline Dengue duo (NS1 Ag/IgG/IgM) | Sensitivity NS1 92%, IgM/IgG 94% (vs RT-PCR); specificity NS1 98%, IgG/IgM 96% (vs ELISA; From Manufacturer) [29] Sensitivity 89%; specificity 100% (vs0 ELISA) [30] |
| Plasmodium sp. (malaria) | Lateral flow RDT as per national guidelines | SD Bioline Malaria Ag P.F/PAN, Abbott | Sensitivity 100% (Pf), 95%(non-Pf); specificity 99% (from Manufacturer) [31] Sensitivity 99% (Pf), 93% (non-Pf); specificity, 98% (Pf), and 100%, non-Pf) [32] |
| CRP | Immunoassay for the quantitative measurement of CRP level in human serum, plasma and whole blood | Standard F CRP, SD Biosensor | Coefficient of variation 7.6%–8.1% (CRP; from Manufacturer) [33] |
| White blood cell differentiation | Five-part differentiation of white blood cell lines | HemoCue® WBC DIFF System, Hemocue | Measuring range: 0.3–30.0 × 109/L (From Manufacturer) [34, 35] Reliable comparability in the range of 0.4–30.0 × 09/L (vs calibrated reference blood cell analyzer) [36] |
| Urine tests | Urine dipstick test for urinary blood, bilirubin, ketones, pH, urobilinogen, protein, nitrites, leucocyte esterase and specific gravity | Multistix SG-10, Siemens SD UrocolorTM 10, Abbott |
Multistix SG-10, Siemens
Sensitivity 88% (visual reading) 97% (instrument reading); specificity 93% (vs culture; from Manufacturer) [37] Sensitivity nitrite, leukocyte esterase, blood and protein 97% Specificity for nitrite, leukocyte esterase and blood 97% (94.2–98.6) (vs culture) [38] SD Urocolor TM 10, Abbott Sensitivity/specificity by Manufacturer (not available) |
Abbreviations: CI, confidence interval; CRP, C-reactive protein; ELISA, enzyme-linked immunosorbent assay; IgG, immunoglobulin G; IgM, immunoglobulin M; NP, nasopharyngeal; Pf, P. falciparum; RDT, rapid diagnostic test; RSV, respiratory syncytial virus; RT-PCR, reverse transcription polymerase chain reaction; WBC, white blood cell.
Dengue tests were not performed in Uganda and Ghana.