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Interpreting ambiguous 'trace' results in Schistosoma mansoni CCA Tests: estimating sensitivity and specificity of ambiguous results with no gold standard.

Abstract The development of new diagnostics is an important tool in the fight against disease. Latent Class Analysis (LCA) is used to estimate the sensitivity and specificity of tests in the absence of a gold standard. The main field diagnostic for Schistosoma mansoni infection, Kato-Katz (KK), is not very sensitive at low infection intensities. A point-of-care circulating cathodic antigen (CCA) test has been shown to be more sensitive than KK. However, CCA can return an ambiguous 'trace' result between 'positive' and 'negative', and much debate has focused on interpretation of traces results.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title plos neglected tropical diseases
Publication Year Start




PMID- 29220354
OWN - NLM
STAT- Publisher
LR  - 20171208
IS  - 1935-2735 (Electronic)
IS  - 1935-2727 (Linking)
VI  - 11
IP  - 12
DP  - 2017 Dec 8
TI  - Interpreting ambiguous 'trace' results in Schistosoma mansoni CCA Tests:
      estimating sensitivity and specificity of ambiguous results with no gold
      standard.
PG  - e0006102
LID - 10.1371/journal.pntd.0006102 [doi]
AB  - BACKGROUND: The development of new diagnostics is an important tool in the fight 
      against disease. Latent Class Analysis (LCA) is used to estimate the sensitivity 
      and specificity of tests in the absence of a gold standard. The main field
      diagnostic for Schistosoma mansoni infection, Kato-Katz (KK), is not very
      sensitive at low infection intensities. A point-of-care circulating cathodic
      antigen (CCA) test has been shown to be more sensitive than KK. However, CCA can 
      return an ambiguous 'trace' result between 'positive' and 'negative', and much
      debate has focused on interpretation of traces results. METHODOLOGY/PRINCIPLE
      FINDINGS: We show how LCA can be extended to include ambiguous trace results and 
      analyse S. mansoni studies from both Cote d'Ivoire (CdI) and Uganda. We compare
      the diagnostic performance of KK and CCA and the observed results by each test to
      the estimated infection prevalence in the population. Prevalence by KK was higher
      in CdI (13.4%) than in Uganda (6.1%), but prevalence by CCA was similar between
      countries, both when trace was assumed to be negative (CCAtn: 11.7% in CdI and
      9.7% in Uganda) and positive (CCAtp: 20.1% in CdI and 22.5% in Uganda). The
      estimated sensitivity of CCA was more consistent between countries than the
      estimated sensitivity of KK, and estimated infection prevalence did not
      significantly differ between CdI (20.5%) and Uganda (19.1%). The prevalence by
      CCA with trace as positive did not differ significantly from estimates of
      infection prevalence in either country, whereas both KK and CCA with trace as
      negative significantly underestimated infection prevalence in both countries.
      CONCLUSIONS: Incorporation of ambiguous results into an LCA enables the effect of
      different treatment thresholds to be directly assessed and is applicable in many 
      fields. Our results showed that CCA with trace as positive most accurately
      estimated infection prevalence.
FAU - Clements, Michelle N
AU  - Clements MN
AUID- ORCID: http://orcid.org/0000-0002-3442-3947
AD  - Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.
FAU - Donnelly, Christl A
AU  - Donnelly CA
AD  - MRC Centre for Outbreak Analysis and Modelling, Department of Infectious Disease 
      Epidemiology, Imperial College London, London, United Kingdom.
FAU - Fenwick, Alan
AU  - Fenwick A
AD  - Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.
FAU - Kabatereine, Narcis B
AU  - Kabatereine NB
AD  - Schistosomiasis Control Initiative, Imperial College, Kampala, Uganda.
FAU - Knowles, Sarah C L
AU  - Knowles SCL
AD  - Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.
AD  - The Royal Veterinary College, Hawkshead Lane, Hatfield, Hertfordshire, United
      Kingdom.
FAU - Meite, Aboulaye
AU  - Meite A
AD  - Cote d'Ivoire Ministry of Health, National Program Against Filariasis,
      Schistosomiasis and Geohelminths, Abidjan, Cote d'Ivoire.
FAU - N'Goran, Eliezer K
AU  - N'Goran EK
AD  - Unite de Formation et de Recherche Biosciences, Universite Felix
      Houphouet-Boigny, Abijan, Cote d'Ivoire.
FAU - Nalule, Yolisa
AU  - Nalule Y
AD  - Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.
FAU - Nogaro, Sarah
AU  - Nogaro S
AD  - Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.
FAU - Phillips, Anna E
AU  - Phillips AE
AD  - Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.
FAU - Tukahebwa, Edridah Muheki
AU  - Tukahebwa EM
AD  - Vector Control Division, Ministry of Health Uganda, Kampala, Uganda.
FAU - Fleming, Fiona M
AU  - Fleming FM
AD  - Schistosomiasis Control Initiative, Imperial College, London, United Kingdom.
LA  - eng
PT  - Journal Article
DEP - 20171208
PL  - United States
TA  - PLoS Negl Trop Dis
JT  - PLoS neglected tropical diseases
JID - 101291488
EDAT- 2017/12/09 06:00
MHDA- 2017/12/09 06:00
CRDT- 2017/12/09 06:00
PHST- 2017/08/08 00:00 [received]
PHST- 2017/11/07 00:00 [accepted]
PHST- 2017/12/09 06:00 [entrez]
PHST- 2017/12/09 06:00 [pubmed]
PHST- 2017/12/09 06:00 [medline]
AID - 10.1371/journal.pntd.0006102 [doi]
AID - PNTD-D-17-01088 [pii]
PST - aheadofprint
SO  - PLoS Negl Trop Dis. 2017 Dec 8;11(12):e0006102. doi:
      10.1371/journal.pntd.0006102.