Table 3.
Limit of detection (LoD) for nine rapid diagnostic tests.
| Rapid Diagnostic Test | In vitro Limit of DetectionParasites/µL [95% CI] | Lowest recorded positive result (Parasites/µL) | ||
|---|---|---|---|---|
| PkA1-H.1 culture isolate*# | Pf3D7 culture isolate¥ | P. knowlesi clinical sample° | ||
| Pan-pLDH | Pan-pLDH | HRP2 | Pan-pLDH | |
| First Response | 98.03 [89.66 - 106.40] |
98.09 [89.68-106.49] |
<7.8 [n/a] |
50 |
| CareStart™ PAN | 24.63 [18.20 - 31.05] |
49.18 [41.75-56.62] |
n/a | 50 |
| STANDARD Q | 195.61 [186.26-204.97] |
778.73 [767.39-790.09] |
24.67 [18.21-31.13] |
40 |
| CareStart™ combo | 98.03 [89.66 - 106.40] |
195.69 [186.29-205.08] |
12.39 [6.90-17.87] |
50 |
| Parascreen® | 195.61 [186.26 - 204.97] |
195.69 [186.29-205.08] |
<7.8 [n/a] |
50 |
| One Step test MERISCREEN | 1555.14 [1543.24 - 1567.05] |
390.48 [380.08-400.89] |
24.67 [18.21-31.13] |
– |
| SD BIOLINE | >2000 [n/a] |
1556.54 [1544.88-1568.19] |
12.39 [6.90-17.87] |
254 |
| Pv-pLDH | Pf-pLDH | Pf-HRP2 | Pv-pLDH | |
| Biocredit™ | 49.18 [41.75 - 56.62] |
49.18 [41.75-56.62] |
n/a | 40 |
| FalciVax | 49.18 [41.75 - 56.62] |
n/a | 12.39 [6.90-17.87] |
50 |
*No P. falciparum-HRP2 bands were detected with the Pk A1-H.1 culture isolate for any of the RDTs screened (i.e., no cross-reactivity).
#No P. falciparum bands were detected with the Pk A1-H.1 culture isolate for either of the RDTs screened, but cross reactivity was observed with P. vivax lines.
¥No P. vivax lines were detected with the Pf3D7 culture isolate (i.e., no cross-reactivity).
° Includes patients tested before antimalarial treatment only.
n/a, Not Applicable.