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Diagnosis of leptospirosis utilizing modified Faine's criteria

Article  in  The Journal of the Association of Physicians of India · September 2004

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Singh Shivakumar
Stanley Medical College
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Profile of Human Leptospirosis

ARTICLE 3

DIAGNOSIS OF LEPTOSPIROSIS UTILIZING MODIFIED

FAINE’s CRITERIA

In a letter published in JAPI 2003, I had stated that certain modification to

be made on Faine’s criteria (WHO guidelines) to diagnose current leptospiral
infection in Indian institutions.1 A prospective study done in patients with
Leptospirosis is presented by us utilizing the modified Faine’s criteria. Faine had
evolved a criteria for diagnosis of Leptospirosis on the basis of clinical,
epidemiological and laboratory data (A+B+C).2 The modifications in the Faine’s
criteria has been made by us in the epidemiological and laboratory criteria
(Table1). No modifications have been made in the clinical aspects of Leptospirosis
(Part A). A score of 26 or more when using PART A, PART A+B or 25 or more
using PART A+B+C can be considered as current Leptospirosis.

The reasons for the modifications are:

(1) Most of the cases of Leptospirosis are reported in the monsoon and post
Monsoon seasons. Therefore, factors such as rainfall and contact with
contaminated environment have been incorporated with appropriate
scores (Part B).

(2) Laboratory tests are very essential for diagnosis of Leptospirosis. ELISA
IgM and Slide agglutination tests (SAT) are simple, sensitive tests and
can be used to diagnose current Leptospirosis. They have been included
with appropriate scores (Part C). Microscopic agglutination tests (MAT)
is the Gold standard test, but it is complicated and less sensitive
compared to ELISA and SAT.

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 The difficulties in utilizing MAT are due to the following factors:
a) The antibody titers rise and peak only in 2nd or 3rd week, making it a less
sensitive test.
b) The high titers of past infection persist for a long time (1-5years) and therefore
interfere with the diagnosis of current leptospirosis. A Positive titer may
represent a rising titer of current infection or declining titer of past infection.
c) The cut off titer for diagnosis of current infection depends in whether the area
is endemic or non-endemic, for example the cut off titer varies from 1/80 to
1/400. Therefore a second sample is usually required (to demonstrate 4 fold
rise in titer) to diagnose current infection. Sero-epidemiological studies are
required for determining the cutoff value.
d) The test is complicated requiring dark field microscopy and cultures of various
live serovars, which may not be available in small laboratories.
As Elisa and SAT measures IgM antibodies become positive by 5th day, they
are the tests of choice for diagnosis of current infection and more over a single
sample is adequate. A repeat sample is necessary, if the first sample is negative.
High titers and rising titers of MAT have been given appropriate scores (Part C).
This study has been undertaken to compare the standard and modified
Faine’s criteria. The original Faiane’s criteria (WHO guidelines) have been
designated as Standard Faine’s criteria in this study. One hundred and fifty patients
admitted with fever were taken up for the study from April 2002 to March 2003.
Leptospirosis was diagnosed by positive macroscopic slide agglutination test
(confirmed by MAT). Malaria, enteric fever, UTI, pneumonia and TB was excluded
by appropriate tests. Thirty-one of 150 patients (20.7%) were diagnosed to have
Leptospirosis. All these patients had both standard and modified Faine’s criteria
positive (A+B+C > 25). It is observed that 38% (22/57) of the patients with fever
had Leptospirosis during monsoon when compared to 9% in the non-monsoon season
(9/93).
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Profile of Human Leptospirosis

Table 1

Faine’s Criteria Modified Faine’s Criteria

Part A : Clinical Data Part A : Clinical Data
Question Score Question Score
Headache 2 Headache 2
Fever 2 Fever 2
Temp > 39ºC 2 Temp > 39ºC 2
Conjunctival suffusion 4 Conjunctival suffusion 4
Meningism 4 Meningism 4
Muscle pain 4 Muscle pain 4
Conjunctival suffusion Conjunctival suffusion
+ Meningism 10 + Meningism 10
+ Muscle pain + Muscle pain
Jaundice 1 Jaundice 1
Albuminuria/Nitrogen 2 Albuminuria/Nitrogen 2
Retention Retention
Total score Total score

Part B: Epidemiological factors Part B: Epidemiological Factors

Contact with animals or Rainfall 5

Contact with known 10 4
Contact with contaminated
Contaminated water
Environment
Animal contact 1
Total Total

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Part C: Bacteriological and Lab Part C: Bacteriological and Lab
Findings Findings

Isolation of leptospira in culture Isolation of leptospira in culture

– Diagnosis certain – Diagnosis certain

Positive Serology (MAT) Positive Serology

Leptospirosis Endemic

Single positive – Low titre 2 ELISA IgM Positive * 15

Single positive – High titre 10 SAT – Positive 15

Leptospirosis Non Endemic

Single positive – Low titre 5 MAT – Single High titre * 15
Single positive – High titre 15 Rising titre (Paired sera) 25
Rising titre (Paired sera) 25

Total Score Total Score

* Any one of the tests only should be scored

Table 2
(PART A+B) Seropositive Seronegative
Standard Faine’s Criteria
Faine’s positive 13 18
Faiane’s negative 18 101
31 119
Modified Faine’s Criteria
Faine’s positive 18 3
Faine’s negative 13 116
31 119

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Profile of Human Leptospirosis

Table 3
(PART A+B) Sensitivity Specificity PPV NPV
Standard Faine’s 41.9% 84.9 41.9% 84.9%
criteria

Modified Faine’s 58% 97.4 85.7% 89.9%

criteria

Statistical NS p value p value NS

significance <0.001 <0.001

As Leptospirosis tests become positive only after the fifth day, the
diagnosis of Leptospirosis has to be done only by clinical and epidemiological
criteria during this period. Hence the clinical and epidemiological criteria (A+B)
only have been compared between standard and modified Faine’s criteria
(Table 2). The standard Faine’s criteria had a sensitivity of 41.9%, specificity of
84.9% and a positive predictive value of 41.9%. It was observed that the positive
features (A+B>26) were more in seronegative leptospirosis compared to
seropositive Leptospirosis. In contrast, modified Faine’s criteria had a sensitivity
of 58%, Specificity of 97.4% and positive predictive value (PPV) of 85.7%. By
modifying the epidemiological factors a significantly better PPV and specificity
was obtained in the modified Faine’s criteria. (Table 3). A study conducted by
AM Bal et al utilizing Faine’s criteria had observed that the sensitivity and PPV to
be 81.8% and 40.9% respectively3. In our study the PPV was much higher
utilizing modified Faine’s criteria though the sensitivity was low. An important
observation in the study has been the importance of laboratory tests. If clinical
and epidemiological criteria (A+B) along were utilized, only 18 cases were
diagnosed by modified Faine’s criteria (sensitivity – 58%), but if lab criteria was
incorporated 31 cases were diagnosed (A+B+C). This is because if A+B alone

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were utilized, the score should be > 26, but if C is available, A+B can be just 11
(A+B=11+C=15 TOTAL=26). If lab criteria are included, the score in PART A
(Clinical features) can be just 2, PART B (epidemiological factors) 9 and PART C
(Laboratory test) 15 (TOTAL=26). Thus milder cases can be diagnosed if
laboratory tests are available. In addition, the modified Faine’s criteria makes it
more difficult to diagnose Leptospirosis in the non monsoon months as the
epidemiological factors would be minimal (PART A=10, PART B=0, PART
C=15).4
We would like to emphasize that the study has been done in symptomatic
patients only (A+B+C) to diagnose current Leptospirosis. It can be argued that a
score of 25 or more can be obtained from B+C along in asymptomatic patients.
This would be relevant only for epidemiological studies to evaluate the prevalence
rates of Leptospirosis in high-risk group and general population. This study has
been done to evaluate a simple method to diagnose current leptospiral infection,
with necessary modification of Faine’s criteria. Though other criteria are utilized,
this criteria is most useful because it utilizes clinical, epidemiological and lab
features.
To conclude, modified Faine’s criteria is a more a practical methods to
diagnose current Leptospirosis. Availability of simple diagnostic tests (ELISA –
IgM or SAT) should help in diagnosis of milder forms (Anicteric) of
Leptospirosis, which is more common (90%) than severe Leptospirosis (10%).

S. Shivakumar*, PS Shareek**
*Professor; ** Post Graduate; Department of Medicine,
Government Stanley Medical College and Hospital, Chennai

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 Profile of Human Leptospirosis

REFERENCES:

1. Shivakumar S. Leptospirosis evaluation. J Assoc Phys India 2003;51:

329-30
2. Faine.S. Guidelines for the control of Leptospirosis. WHO offset
publication 1982:67.
3. Bal AM, Kalkarni AL, Bharadwaj RS, Kagal AS, Joshi SA, Wadkov VP.
Evaluation of clinical criteria for diagnosis of Leptospirosis. J Assoc Phys
India 2002;50:394-6
4. Shivakumar S. Approach to Leptospirosis in India. Bhattacharya PK(Ed);
Medicine Update – APICON, Assam, 2003;7:699 – 703.

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