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Table 1 Shows malaria diagnosis for 115 retrospective samples by the illumigene malaria assay in comparison with standard microscopy, RDT and PCR

From: Diagnostic performance of the loop-mediated isothermal amplification (LAMP) based illumigene® malaria assay in a non-endemic region

  Reference method (RDT, microscopy, PCR) Illumigene malaria assay
Results (n) Range parasite density (asexual parasites/µL) Results (n) Performance
Total 108   108  
 Positive  74    74 Sensitivity (%) (95% CI) 100% (95.1–100%)
 Negative  34    34 Specificity (%) (95% CI) 100% (89.7–100%)
Clinical samples 96    
 Pf  27 (1–372,117)  –*
 Pv  14 (169–18,777)  –*
 Pm  13 (106–9244)  –*
 Po  12 (31–6461)  –*
 Mixed  0   
 Negative  30   
External quality controls 12   
 Pf  1 5  –*
 Pv  1 5  –*
 Pm  2 5  –*
 Po  3 20  –*
 Pk  1 10,000  
 Negative  4   
  1. The retrospective panel consisted of 103 clinical samples (96 diagnostic samples and 7 samples from patients who already received treatment for malaria infection) and 12 external quality controls. These 7 samples from patients who already received treatment (115 − 7 = 108) were excluded from the calculation of both sensitivity and specificity. Parasite density as quantified by microscopy on blood smear
  2. RDT, rapid diagnostic test; PCR, four-primer real-time PCR; Pf, Plasmodium falciparum; Pm, Plasmodium malariae; Po, Plasmodium ovale; Pv, Plasmodium vivax; Pk, Plasmodium knowlesi; n, number of samples; –*, the illumigene malaria assay does not distinguish between Plasmodium species