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to catch West Nile virus
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Next generation West Nile virus ELISAs
1
West Nile Virus IgM Capture ELISA performance
Agreement with CDC MAC EIA
WNV (presumptive by CDC MAC EIA)
Agreement
95% Confidence Interval
Positive agreement
11/11 (100%)
71.5 - 100%
Negative agreement
61/62 (98.4%)
91.3 - 100%
Clinical sensitivity
Specimen characterization
No. Pos/Total Pos
Sensitivity
95% Confidence Interval
51/51
100.0%
93.0 -100.0%
Encephalitis/meningitis patients
(confirmed WNV infection by PRNT)
Cross-reactivity data
Disease state
(IgM antibodies)
Panbio WNV IgM Capture ELISA
Positive
Equivocal
Total Reactive
Epstein-Barr virus
Varicella-zoster virus
Cytomegalovirus
Ross River virus
Enterovirus
Dengue virus
St. Louis encephalitis
La Crosse encephalitis
Hepatitis A
Anti-nuclear antibody
Rheumatoid factor
0
0
0
0
0
2
0
0
0
0
3
0
0
0
0
0
0
0
0
0
0
1
0/15
0/15
0/15
0/26
0/7
2/16
0/6
0/19
0/11
0/15
4/15
0.0%
0.0%
0.0%
0.0%
0.0%
12.5%
0.0%
0.0%
0.0%
0.0%
26.7%
Total
5
1
6/160
3.8%
Panbio ELISA methodology
The Panbio West Nile Virus ELISAs are designed to assist in the clinical laboratory diagnosis of West Nile
virus infection in patients with clinical symptoms consistent with encephalitis/meningitis.2
West Nile Virus IgM Capture ELISA
Superior specificity and is even simpler to use 3.
Results in 2.5 hours.
West Nile Virus IgG Indirect ELISA
Use with the Panbio WNV IgM Capture ELISA.
Results in 1.5 hours.
WNV IgM ELISA
WNV IgG ELISA
Prepare 1/100 serum dilution
Add 100 µL sample to wells
incubate 60 min (37°C)
WASH x 6
Prepare 1/100 serum dilution
Add equal volume of MAb
Tracer and Antigen.
Incubate 60 min (RT).
Add 100 µL sample to wells.
Incubate 30 min (37°C).
WASH x 6
Add 100 µL Antigen/MAb to wells.
Incubate 60 min (37°C).
Add 100 µL of Conjugate to wells.
Incubate 30 min (37°C).
WASH x 6
WASH x 6
Add 100 µL TMB to wells.
Incubate 10 min (RT).
Add 100 µL TMB to wells.
Incubate 10 min (RT).
Add 100 µL Stop Solution
to wells.
Add 100 µL Stop Solution
to wells.
READ 450 nm
reference filter 600-650 nm
READ 450 nm
reference filter 600-650 nm
The most efficient diagnostic method is detection
of IgM antibody to West Nile virus in serum...
Petersen LR et al., 2002
4
1
West Nile Virus IgG Indirect ELISA performance
Negative presumptive agreement5
Specimen characterization
Agreement
95% Confidence Interval
Endemic normal specimens
181/200 (90.5%)
85.6 - 94.2%
Endemic normal specimens
180/195 (92.3%)
87.6 - 95.6%
Positive presumptive agreement compared with IFA5
Specimen characterization
Agreement
95% Confidence Interval
IgG IFA positive
26/32 (81.3%)
63.6 - 92.8%
IgG IFA positive
29/38 (76.3%)
59.8 - 88.6%
IgG IFA positive
286/325 (88.0%)
84.5 - 91.5%
Serological sensitivity
Specimen characterization
WNV positive specimens
(PRNT positive)
No. Pos/Total Pos
Sensitivity
79/100
79.0%
95% Confidence Interval
69.7 - 86.5%
Specimen characterization
Encephalitis/meningitis patients
(WNV confirmed infection by PRNT)
No. pos/total pos
41/51
Sensitivity
80.4%
95% Confidence Interval
66.9 - 90.2%
better tests for more people
Clinical sensitivity
Ordering information
Product
Description
ELISA
E-WNV02M
E-WNV01G
West Nile Virus IgM Capture ELISA
West Nile Virus IgG Indirect ELISA
No. of tests
96
96
Also available
Also available through Panbio is a range of IFA kits and slides
Product
Description
IFA kits#
I-WNV01G
I-WNV01M
West Nile virus IgG
West Nile virus IgM
IFA components
I-WNV01X*
CC093*
O-GAH02G*
O-GAH02M*
O-GAH02A*
West Nile Virus Slides
West Nile Virus Positive Control Serum
Goat Anti-human IgG (H+L) FITC
Goat Anti-human IgM FITC
Goat Anti-human IgA FITC
Other reagents
O-AVR02G*
Buffered Avidity Reagent
No. of tests
120
120
10 x 12 well
250 mL
5 mL (200T)
5 mL (200T)
5 mL (200T)
50 mL
*Analyte Specific Reagent. Analytic and performance characteristics are not established.
#Product not available for sale or distribution in the USA.
1 The
data presented is extracted from the West Nile Virus IgM and IgG instructions for use and is representative of the performance of the kit. Please refer
to the instructions for use for further performance data and details on the study sites. Assay performance characteristics have not been
established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningioencephalitis or automated
instruments. The user is responsible for establishing these assay performance characteristics.
2 Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention
(CDC) guidelines for diagnosis of this disease.
3 When compared to the previous generation of this product (E-WNV01M).
4 Petersen LR, et al. (2002). NEJM 347; 1225-26.
5 Data from varous study sites is presented in this table. Please refer to the instructions for use for further details.
For further information please visit www.panbio.com or contact either Panbio or your Panbio distributor.
Panbio Limited. 532 Seventeen Mile Rocks Rd, Sinnamon Park, Queensland, 4073 Australia.
tel: +61 7 3357 1177 fax: +61 7 3357 1222 free-call: 1800 622 642
Panbio Inc. 9075 Guilford Rd, Columbia, 21046 MD USA.
tel: +1 410 381 8550 fax: +1 410 381 8984 toll free: 800 962 6790
web: www.panbio.com email: panbio@panbio.com PB0057 Rev 2005/04
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