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Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries

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Abstract
Background : Because the success of deworming programs targeting soil-transmitted helminths (STHs) is evaluated through the periodically assessment of prevalence and infection intensities, the use of the correct diagnostic method is of utmost importance. The STH community has recently published for each phase of a deworming program the minimal criteria that a potential diagnostic method needs to meet, the so-called target product profiles (TPPs). Methodology : We compared the diagnostic performance of a single Kato-Katz (reference method) with that of other microscopy-based methods (duplicate Kato-Katz, Mini-FLOTAC and FECPAK(G2)) and one DNA-based method (qPCR) for the detection and quantification of STH infections in three drug efficacy trials in Ethiopia, Lao PDR, and Tanzania. Furthermore, we evaluated a selection of minimal diagnostic criteria of the TPPs. Principal findings : All diagnostic methods showed a clinical sensitivity of >= 90% for all STH infections of moderate-to-heavy intensities. For infections of very low intensity, only qPCR resulted in a sensitivity that was superior to a single Kato-Katz for all STHs. Compared to the reference method, both Mini-FLOTAC and FECPAK(G2) resulted in significantly lower fecal egg counts for some STHs, leading to a substantial underestimation of the infection intensity. For qPCR, there was a positive significant correlation between the egg counts of a single Kato-Katz and the DNA concentration. Conclusions/Significance : Our results indicate that the diagnostic performance of a single Kato-Katz is underestimated by the community and that diagnostic specific thresholds to classify intensity of infection are warranted for Mini-FLOTAC, FECPAK(G2) and qPCR. When we strictly apply the TPPs, Kato-Katz is the only microscopy-based method that meets the minimal diagnostic criteria for application in the planning, monitoring and evaluation phase of an STH program. qPCR is the only method that could be considered in the phase that aims to seek confirmation for cessation of program.
Keywords
REAL-TIME PCR, STRONGYLOIDES-STERCORALIS, INTESTINAL PARASITES, NECATOR-AMERICANUS, MULTI-PARALLEL, INFECTIONS, HOOKWORM, ACCURACY, TESTS

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MLA
Cools, Piet, et al. “Diagnostic Performance of a Single and Duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and QPCR for the Detection and Quantification of Soil-Transmitted Helminths in Three Endemic Countries.” PLOS NEGLECTED TROPICAL DISEASES, vol. 13, no. 8, 2019, doi:10.1371/journal.pntd.0007446.
APA
Cools, P., Vlaminck, J., Albonico, M., Ame, S., Heda, M., José Antonio, B. P., … Levecke, B. (2019). Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries. PLOS NEGLECTED TROPICAL DISEASES, 13(8). https://doi.org/10.1371/journal.pntd.0007446
Chicago author-date
Cools, Piet, Johnny Vlaminck, Marco Albonico, Shaali Ame, Mio Heda, Barrios Perez José Antonio, Giuseppe Cringoli, et al. 2019. “Diagnostic Performance of a Single and Duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and QPCR for the Detection and Quantification of Soil-Transmitted Helminths in Three Endemic Countries.” PLOS NEGLECTED TROPICAL DISEASES 13 (8). https://doi.org/10.1371/journal.pntd.0007446.
Chicago author-date (all authors)
Cools, Piet, Johnny Vlaminck, Marco Albonico, Shaali Ame, Mio Heda, Barrios Perez José Antonio, Giuseppe Cringoli, Daniel Dana Medebo, Jennifer Keiser, Maria P Maurelli, Catalina Maya, Leonardo F Matoso, Antonio Montresor, Zeleke Mekonnen, Greg Mirams, Rodrigo Corrêa-Oliveira, Simone A Pinto, Laura Rinaldi, Somphou Sayasone, Eurion Thomas, Jaco J Verweij, Jozef Vercruysse, and Bruno Levecke. 2019. “Diagnostic Performance of a Single and Duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and QPCR for the Detection and Quantification of Soil-Transmitted Helminths in Three Endemic Countries.” PLOS NEGLECTED TROPICAL DISEASES 13 (8). doi:10.1371/journal.pntd.0007446.
Vancouver
1.
Cools P, Vlaminck J, Albonico M, Ame S, Heda M, José Antonio BP, et al. Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries. PLOS NEGLECTED TROPICAL DISEASES. 2019;13(8).
IEEE
[1]
P. Cools et al., “Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries,” PLOS NEGLECTED TROPICAL DISEASES, vol. 13, no. 8, 2019.
@article{8641266,
  abstract     = {{Background : Because the success of deworming programs targeting soil-transmitted helminths (STHs) is evaluated through the periodically assessment of prevalence and infection intensities, the use of the correct diagnostic method is of utmost importance. The STH community has recently published for each phase of a deworming program the minimal criteria that a potential diagnostic method needs to meet, the so-called target product profiles (TPPs). 
Methodology : We compared the diagnostic performance of a single Kato-Katz (reference method) with that of other microscopy-based methods (duplicate Kato-Katz, Mini-FLOTAC and FECPAK(G2)) and one DNA-based method (qPCR) for the detection and quantification of STH infections in three drug efficacy trials in Ethiopia, Lao PDR, and Tanzania. Furthermore, we evaluated a selection of minimal diagnostic criteria of the TPPs. 
Principal findings : All diagnostic methods showed a clinical sensitivity of >= 90% for all STH infections of moderate-to-heavy intensities. For infections of very low intensity, only qPCR resulted in a sensitivity that was superior to a single Kato-Katz for all STHs. Compared to the reference method, both Mini-FLOTAC and FECPAK(G2) resulted in significantly lower fecal egg counts for some STHs, leading to a substantial underestimation of the infection intensity. For qPCR, there was a positive significant correlation between the egg counts of a single Kato-Katz and the DNA concentration. 
Conclusions/Significance : Our results indicate that the diagnostic performance of a single Kato-Katz is underestimated by the community and that diagnostic specific thresholds to classify intensity of infection are warranted for Mini-FLOTAC, FECPAK(G2) and qPCR. When we strictly apply the TPPs, Kato-Katz is the only microscopy-based method that meets the minimal diagnostic criteria for application in the planning, monitoring and evaluation phase of an STH program. qPCR is the only method that could be considered in the phase that aims to seek confirmation for cessation of program.}},
  articleno    = {{e0007446}},
  author       = {{Cools, Piet and Vlaminck, Johnny and Albonico, Marco and Ame, Shaali and Heda, Mio and José Antonio, Barrios Perez and Cringoli, Giuseppe and Medebo, Daniel Dana and Keiser, Jennifer and Maurelli, Maria P and Maya, Catalina and Matoso, Leonardo F and Montresor, Antonio and Mekonnen, Zeleke and Mirams, Greg and Corrêa-Oliveira, Rodrigo and Pinto, Simone A and Rinaldi, Laura and Sayasone, Somphou and Thomas, Eurion and Verweij, Jaco J and Vercruysse, Jozef and Levecke, Bruno}},
  issn         = {{1935-2735}},
  journal      = {{PLOS NEGLECTED TROPICAL DISEASES}},
  keywords     = {{REAL-TIME PCR,STRONGYLOIDES-STERCORALIS,INTESTINAL PARASITES,NECATOR-AMERICANUS,MULTI-PARALLEL,INFECTIONS,HOOKWORM,ACCURACY,TESTS}},
  language     = {{eng}},
  number       = {{8}},
  pages        = {{22}},
  title        = {{Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries}},
  url          = {{http://dx.doi.org/10.1371/journal.pntd.0007446}},
  volume       = {{13}},
  year         = {{2019}},
}

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