title: A comparative study on microscopic agglutination test and counterimmunoelectrop- horesis for early detection of human leptospirosis.
abstract: OBJECTIVE
  Leptospirosis is a potentially fatal bacterial disease that mimics many diseases; therefore, laboratory confirmation is pivotal. Though microscopic agglutination test (MAT) is accepted as World Health Organisation (WHO) reference test, it has got many pitfalls such as being hazardous, tedious, cumbersome and expensive. Counterimmunoelectrophoresis (CIE) is popularly used for diagnosing many infectious diseases but rarely for Leptospirosis. The aim of this study is to find suitability of CIE for the routine laboratory diagnostic purposes.
  
  
  METHODS
  Repeat sampling (paired sera) was possible from 401 subjects of which 181 were in-patients of Salem Government General and Private Hospitals and the remaining 220 MAT negative healthy College students gave their consent for the study. All the 802 sera samples were collected from January 2009 to November 2012 and subjected to the present study. After carrying out MAT and CIE on the suspected and control samples, a comparative evaluation was conducted. McNemars test method was used to find out the significant difference between the two tests in the early diagnosis.
  
  
  RESULTS
  The sensitivity, specificity, Positive Predictive value (PPV), Negative Predictive value (NPV) and Efficiency test for CIE were 96.80%, 89.28%, 95.23%, 92.59% and 94.47%, respectively. The corresponding values for MAT were 95.90%, 89.83%, 95.08%, 91.37% and 93.92%, respectively. There was no significant difference between MAT and CIE at 95% and 99% confidence intervals according to McNemars test. P value in the early stage of illness was greater for CIE than MAT when Polymerase Chain Reaction (PCR) was used as Gold Standard of diagnosis.
  
  
  CONCLUSIONS
  It was concluded that the CIE could be advantageous over MAT due to its safety, rapidity, simplicity, economic and easy for large number of samples. It can answer little earlier than MAT and found as reliable as that of MAT. Since both the tests had shown similar efficacies in the later stage of the illness, the importance could be given to CIE due to early diagnosis.
authors.affiliation: Department of Biotechnology, Biomedical Engineering and Research Foundation, Periyar University, Salem, Tamil Nadu, India.
authors.forename: R
authors.initials: R
authors.lastname: Saravanan
authors.forename: P
authors.initials: P
authors.lastname: Saradhai
authors.forename: E
authors.initials: E
authors.lastname: Rani
authors.forename: V
authors.initials: V
authors.lastname: Rajasekar
mesh_terms: D000293:Adolescent; D000372:Agglutination Tests / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D019411:Clinical Laboratory Techniques / Q000379:methods*; D003378:Counterimmunoelectrophoresis / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D007922:Leptospirosis / Q000175:diagnosis*; D008297:Male; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity