Detection of human leptospirosis as a cause of acute fever by capture ELISA using a Leptospira interrogans serovar Copenhageni (M20) derived antigen.
BACKGROUND
Leptospirosis is a potentially lethal zoonosis mainly affecting low-resource tropical countries, including Peru and its neighbouring countries. Timely diagnosis of leptospirosis is critical but may be challenging in the regions where it is most prevalent. The serodiagnostic gold standard microagglutination test (MAT) may be technically prohibitive. Our objective in this study was to assess the sensitivity, specificity, and predictive value of an IgM antibody capture enzyme-linked immunoassay (MAC-ELISA) derived from the M20 strain of Leptospira interrogans serovar Copenhageni (M20) by comparison to MAT, which was used as the gold standard method of diagnosis.


METHODS
Acute and convalescent sera from participants participating in a passive febrile surveillance study in multiple regions of Peru were tested by both IgM MAC-ELISA and MAT. The sensitivity, specificity, positive and negative predictive value (PPV, NPV) of the MAC-ELISA assay for acute, convalescent and paired sera by comparison to MAT were calculated.


RESULTS
The sensitivity, specificity, PPV and NPV of the MAC-ELISA assay for acute sera were 92.3%, 56.0%, 35.3% and 96.6% respectively. For convalescent sera, the sensitivity, specificity, PPV and NPV of the MAC-ELISA assay were 93.3%, 51.5%, 63.6% and 89.5% respectively. For paired sera, the sensitivity, specificity, PPV and NPV of the MAC-ELISA assay were 93.6%, 37.5%, 59.2%, 85.7% respectively.


CONCLUSIONS
The M20 MAC-ELISA assay performed with a high sensitivity and low specificity in the acute phase of illness. Sensitivity was similar as compared with MAT in the convalescent phase and specificity remained low. Paired sera were the most sensitive but least specific by comparison to MAT serodiagnosis. NPV for acute, convalescent and paired sera was high. The limited specificity and high sensitivity of the MAC-ELISA IgM suggests that it would be most valuable to exclude leptospirosis in low-resource regions that lack immediate access to definitive reference laboratory techniques such as MAT.
U,S, Naval Medical Research Unit No, 6, Lima, Peru. spollett@med.usyd.edu.au.
Enrique
E
Canal
Simon
S
Pollett
Kristen
K
Heitzinger
Michael
M
Gregory
Matthew
M
Kasper
Eric
E
Halsey
Yocelinda
Y
Meza
Kalina
K
Campos
Juan
J
Perez
Rina
R
Meza
Maruja
M
Bernal
Alfredo
A
Guillen
Tadeusz J
TJ
Kochel
Benjamin
B
Espinosa
Eric R
ER
Hall
Ryan C
RC
Maves
D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D000942:Antigens, Bacterial / Q000097:blood / Q000276:immunology; D002648:Child; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D005334:Fever / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D006801:Humans; D007921:Leptospira interrogans / Q000235:genetics / Q000276:immunology*; D007922:Leptospirosis / Q000097:blood / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D008297:Male; D008875:Middle Aged; D055815:Young Adult
D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial