Table 1.
Summary of studies evaluating the malaria diagnostic accuracy of Cell-Dyn series analysers using the side-scatter/depolarized side-scatter plot abnormal depolarizing events criterion. §
| First author, year and country | Number of participants and diagnoses | Index test criterion¶ | Sensitivity % | Specificity % |
|---|---|---|---|---|
| Mendelow, 1999, South Africa [18] | Total: 224 directed samples from 175 patients, P. falciparum: 93, Species not specified: 2 | CD** 3500 ≥1 depolarizing events‡ |
72 | 96 |
| Hänscheid, 2001, Portugal† [39] | Total: 174, P. falciparum: 48, P. vivax: 6, P. ovale: 1, P. malariae: 2 | CD 3500 ≥2 depolarizing events |
95 | 88 |
| Wever, 2002, The Netherlands† [36] | Total: 113, P. falciparum: 46, P. vivax: 5, P. ovale: 4, no differentiation for P. vivax or P. ovale: 3 | CD 3500 Either ≥1 depolarizing events or pseudoreticulocytosis |
62 | 96 |
| Grobusch, 2003, Germany† [27] | Total: 403, P. falciparum: 87, P. vivax: 13, P. ovale: 5, P. malariae: 2 | CD 3000 ≥1 depolarizing events |
48.6 | 96.2 |
| Scott, 2003, South Africa [35] | Total: 831, P. falciparum: 334, P. vivax: 7, P. ovale: 1, P. malariae: 2, mixed or unspecified: 6 | CD 4000 ≥1 depolarizing events |
80.2 | 87.3 |
| Suh, 2003, South Korea [32] | Total: 168, P. vivax: 68 | CD 4000 ≥1 depolarizing events |
91.2 | 100 |
| Dromigny, 2005, Senegal [30] | Total: 799 (directed: suspected of malaria 123, non-suspected random samples 676) P. falciparum: 68, treated or subclinical: 83 | CD 3200 ≥1 depolarizing events |
Directed 92.9 Random 90.2 |
Directed 93.8 Random 96.7 |
| Padial, 2005, Equatorial Guinea [41] | Total: 411, P. falciparum: 35 , P. ovale: 3, mixed: 1 | CD 4000 | 72 | 98 |
| Josephine, 2005, Malaysia [40] | Total: 889, P. vivax: 12, P. malariae: 3, P. falciparum: 1 | CD 4000 | 100 | 100 |
| de Langen, 2006, Namibia [42] | Total: 208, P. falciparum: 90 | CD 3700 ≥1 depolarizing events |
93 | 97 |
| Hänscheid, 2008, Gabon [34] | Children, total: 368, P. falciparum: 152 | CD 3000*** ≥1 depolarizing purple events Green-coded events |
a) 96% b) 85% |
a) 96% b) 96% |
| Hänscheid, 2009, Gabon [43] | Pregnant patients, total 685, P. falciparum: 86 | CD 3000 ≥1 depolarizing events |
86.8 | 78.5 |
| Rathod, 2009, India [33] | Total: 523, P. falciparum :73, P. vivax: 62 | CD 3200 ≥1 depolarizing events |
62.2 | 25.3 |
¶Index diagnostic test: abnormal depolarizing events in the side-scatter/depolarized side-scatter plot. ‡All studies use the instrument's diagonal separation line for eosinophils and neutrophils in the side-scatter/depolarized side-scatter plot, unless otherwise specified. ** CD: Cell-Dyn. †Imported malaria. ***For purple events, these were considered positive if present above a line traced at 5 pixels from the x axis. For green events, a special gate was created to identify haemozoin-laden granulocytes, with the intention to exclude eosinophils. In accordance with studies using flow cytometric cell sorting [27], the largest possible gate to the left and above the usual location of the eosinophil population was created which did not contain any eosinophils [34]. For this, CBC analyses from children without malaria or pseudoreticulocytosis were used [34]. §For the complete table with additional comments and reference diagnostic tests used in each study see Additional File 1.