(177 days)
No marketed EIA device was available at the time that performance studies were conducted.
Not Found
No
The summary describes a traditional ELISA assay for detecting antibodies and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) test intended to aid in the diagnosis of West Nile virus infection by detecting antibodies. It does not provide therapy or treatment.
Yes
The device is intended as an aid in the clinical laboratory diagnosis of West Nile virus infection, which directly relates to diagnosing a condition in a patient.
No
The device description clearly indicates it is an ELISA kit, which is a laboratory assay involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "qualitative presumptive detection of IgG antibodies to West Nile virus in serum." It also mentions its use "in conjunction with the PANBIO West Nile Virus IgM Capture ELISA" as an "aid in the clinical laboratory diagnosis of West Nile virus infection." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine a specimen (serum) to provide information for diagnostic purposes.
- Device Description: The "Device Description" reiterates the intended use of detecting antibodies in serum for the presumptive diagnosis of West Nile virus infection.
- Specimen Type: The device uses serum, which is a biological specimen collected from a patient.
- Testing Location: The "Intended User / Care Setting" is a "clinical laboratory," which is where in vitro diagnostic tests are performed.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PANBIO West Nile Virus IgG Indirect ELISA is for the qualitative presumptive detection of IgG antibodies to West Nile virus in serum. In conjunction with the PANBIO West Nile Virus IgM Capture ELISA, this test is intended as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis. 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NOP
Device Description
The PANBIO West Nile Virus IgG Indirect ELISA is for the qualitative detection of IgG antibodies to West Nile virus in serum. In conjunction with the PANBIO West Nile Virus IgM Capture ELISA, this test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
individuals of various ages
Intended User / Care Setting
Clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Study Site 1:
- Sample Size: 300 retrospective sera
- Data Source: Individuals of various ages and both genders from a state health laboratory in Louisiana, USA.
- Annotation Protocol: 100 samples characterized as positive for WN virus by PRNT and 200 randomly selected normal specimens from routine laboratory testing not known to have a flavivirus related illness. Samples were masked.
Study Site 2:
- Sample Size: 325 retrospective sera
- Data Source: Individuals of various ages and both genders from a private reference laboratory in Utah, USA.
- Annotation Protocol: 166 samples characterized positive and 159 samples characterized negative for WNV by IFA slides (ASR). 34 of these samples were from patients with clinical symptoms consistent with encephalitis / meningitis (32 characterized positive and 2 characterized negative for WNV by IFA). Samples were not masked.
Study Site 3:
- Sample Size: 284 retrospective sera
- Data Source: Individuals of various ages and both genders from a hospital laboratory in Ohio, USA, collected in 2002.
- Annotation Protocol: 89 patients with symptoms of encephalitis / meningitis (51 samples confirmed positive for WN virus by PRNT and positive for IFA, and 38 samples positive by IFA), and 195 randomly selected normal specimens from routine laboratory testing, negative for WN virus by IFA. Samples were masked.
Reproducibility Study:
- Sample Size: 8 sera tested 3 times each on 3 different assays (total n=27 for each sample)
- Data Source: One Australian study site and two study sites in the USA.
- Annotation Protocol: Not explicitly stated beyond repeated testing.
Cross-reactivity Study:
- Sample Size: 314 specimens
- Data Source: Patients with confirmed diseases other than WNV.
- Annotation Protocol: Each specimen was characterized with respect to disease state prior to analysis with the PANBIO West Nile Virus IgG Indirect ELISA. Diseases included: Dengue virus, St. Louis encephalitis, Japanese encephalitis, La Crosse encephalitis, California encephalitis, Eastern Equine encephalitis, Varicella-Zoster virus, Cytomegalovirus, Epstein-Barr virus, Enterovirus, Ross River virus, Barmah Forest virus, Rheumatoid Factor, Anti-Nuclear Antibody. Testing conducted at PANBIO (Site 5) and other specified sites for certain diseases.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Site 1 (Performance Characteristics, Diagnostic):
- Sample size: 300 sera (100 WNV PRNT confirmed positive, 200 endemic normal)
- Key results:
- Endemic normal specimens Negative presumptive agreement = 181/200 = 90.5% (95% CI: 85.6 - 94.2%)
- Adjusted specificity = 191/201 = 95.0% (91.0 - 97.6%)
- West Nile virus positive specimens Serological sensitivity (PRNT) = 79/100 = 79.0% (95% CI: 69.7 – 86.5%)
- Adjusted sensitivity = 88/99 = 88.9% (95% CI: 81.0 – 94.3%)
Study Site 2 (Performance Characteristics, Diagnostic):
- Sample size: 325 sera (166 WNV IFA positive, 159 WNV IFA negative; 34 clinical encephalitis/meningitis patients)
- Key results (Encephalitis / Meningitis Patients):
- Encephalitic symptoms (IgG IFA positive) Positive Presumptive Agreement = 26/32 = 81.3% (95% CI: 63.6 – 92.8%)
- WNV (presumptive by (IgG IFA negative)) Negative Presumptive Agreement = 2/2 = 100.0% (95% CI: 15.8 – 100.0%)
- Key results (WNV IFA Characterized Specimens):
- WNV IFA positive (presumptive) Positive Presumptive Agreement = 286/325 = 88.0% (95% CI: 84.5 - 91.5%)
- Negative Presumptive Agreement = 140/159 = 88.1% (95% CI: 83.0 - 93.1%)
Study Site 3 (Performance Characteristics, Diagnostic):
- Sample size: 284 sera (195 endemic normal, 89 encephalitis/meningitis patients)
- Key results:
- Endemic normal specimens Negative Presumptive Agreement = 180/195 = 92.3% (95% CI: 87.6 - 95.6%)
- Encephalitis/meningitis patients Clinical sensitivity (PRNT) = 41/51 = 80.4% (95% CI: 66.9 - 90.2%)
- Positive Presumptive Agreement = 29/38 = 76.3% (95% CI: 59.8 - 88.6%)
Reproducibility Study:
- Study type: Reproducibility (precision measures - ANOVA Type II)
- Sample size: 8 sera, tested 3 times each on 3 different assays (27 total measurements per sample)
- Key results: Provided within-run, between day, between site, and total precision measures (Standard Deviation and Coefficient of Variation) for 8 different samples. For Reactive sample: Total CV 4.2%, Negative sample: Total CV 38.8%. Other samples had total CVs ranging from 9.0% to 41.0%.
Cross-reactivity Study:
- Study type: Analytical Specificity (Cross-reactivity)
- Sample size: 314 specimens
- Key results: Assessed reactivity with other diseases including Dengue virus (14/15 positive/equivocal), St. Louis encephalitis (28/35 positive/equivocal), Japanese encephalitis (3/3 positive/equivocal), La Crosse encephalitis (2/26 positive), California encephalitis (1/11 equivocal), Eastern Equine encephalitis (0/1), Varicella-Zoster virus (0/15), Cytomegalovirus (7/48 positive), Epstein-Barr virus (7/40 positive), Enterovirus (1/15 positive), Ross River virus (11/39 positive/equivocal), Barmah Forest virus (13/36 positive/equivocal), Rheumatoid Factor (4/15 positive), Anti-Nuclear Antibody (2/15 positive). Flavivirus reactivity for some Ross River virus and Barmah Forest virus samples confirmed by Western blot.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Negative presumptive agreement
- Adjusted specificity
- Serological sensitivity (PRNT)
- Adjusted sensitivity
- Positive Presumptive Agreement
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
No marketed EIA device was available at the time that performance studies were conducted. Equivalence shall be demonstrated through gold standard test reference methods.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3940 West Nile virus serological reagents.
(a)
Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See § 866.1(e) for the availability of this guidance document.
0
OCT 2 0 2004
1.9 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K041068
Applicant Information:
| Submission Date: | 21st April, 2004 |
|---|---|
| Date Modified: | 15th October, 2004 |
| Name: | PANBIO Limited |
| Address: | 116 Lutwyche Road, Windsor |
| Queensland 4030 Australia | |
| Contact Person: | |
| Phone Number: | |
| Fax Number: | Craig Breadmore / Jillianne Keller |
| +61-(0)7-3357-1177 | |
| +61-(0)7-3357-1222 |
Device Information:
| Trade Name: | West Nile Virus IgG Indirect ELISA |
|---|---|
| Common Name: | West Nile Virus IgG Indirect EIA Test |
| Classification Name: | West Nile virus, serological reagents (21 CFR 866.3940) |
Equivalent Device:
No marketed EIA device was available at the time that performance studies were conducted. Equivalence shall be demonstrated through gold standard test reference methods. The West Nile Virus IgG Indirect ELISA is a new device that falls under the FDA's classification name "West Nile virus, serological reagents" (21 CFR 866.3940).
Device Description:
The PANBIO West Nile Virus IgG Indirect ELISA is for the qualitative detection of IgG antibodies to West Nile virus in serum. In conjunction with the PANBIO West Nile Virus IgM Capture ELISA, this test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis.
Intended Use:
The PANBIO West Nile Virus IgG Indirect ELISA is for the qualitative presumptive detection of IgG antibodies to West Nile virus in serum. In conjunction with the PANBIO West Nile Virus IgM Capture ELISA, this test is intended as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis. 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.
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.
Principle of Procedure:
Serum antibodies combine with purified and inactivated WNV antigen coated on the polystyrene surface of the microwell test strips (assay plate). Residual serum is removed from the assay plate by washing. HRP-conjugated anti-human IgG monoclonal antibody (Mab) is added to the assay plate. After incubation, the microwells are washed and a colorless substrate system, tetramethylbenzidine/hydrogen peroxide (TMB/H₂O₂), is added. The substrate is hydrolyzed by the HRP, if present, and the chromogen changes to a blue color. After stopping the reaction with acid, the TMB becomes yellow. Color development is indicative of the presence of WNV antibodies in the test sample.
1
PERFORMANCE CHARACTERISTICS Study Site 1:
Three hundred (300) retrospective sera from individuals of various ages and both genders were tested at a state health laboratory in Louisiana, USA. The sera include samples from the following groups: 100 samples characterised as positive for WN virus by PRNT and 200 randomly selected normal specimens from routine laboratory testing not known to have a flavivirus related illness. These samples were masked and tested on the PANBIO West Nile Virus IgG Indirect ELISA and the results were compared to the clinical and serological characterisation of the samples to determine performance of the assay. The data is summarised in Table 1.
Table 1 - Study Site 1 PANBIO West Nile Virus IgG Indirect ELISA Reactivity with Endemic Normal and WNV PRNT Confirmed Specimens
| Specimen Characterisation | PANBIO IgG ELISA Results | Pos | Eqv a | Neg | Total |
|---|---|---|---|---|---|
| Endemic normal specimens | |||||
| (randomly selected) b | 18 d | 1 | 181 | 200 | |
| West Nile virus Positive c | |||||
| (PRNT confirmed) | 79 | 0 | 21 e | 100 | |
| Total | 97 | 1 | 202 | 300 |
a Retesting of equivocals was not conducted as samples were unavailable.
b Randomly selected normal specimens from routine laboratory testing from 2002-2003. Not known to have a flavivirus related illness. Further tested by WNV IgG IFA.
& West Nile virus PRNT positive. Collected in 2002. Further tested by WNV IgG IFA.
8 Nine of the 18 endemic specimens that were positive by PANBIÓ ELISA were also positive by IgG IFA. Refer to note below.
e Ten of the 21 PRNT confirmed positive specimens that were negative by PANBIO ELISA were negative by IgG IFA and positive by PANBIO WNV IgM Capture ELISA.
95% Confidence Interval
Endemic normal specimens Negative presumptive agreement = 181/200 90.5% 85.6 - 94.2% Adjusted specificity ' 91.0 - 97.6% = 191/201 95.0%
West Nile virus positive specimens
| Serological sensitivity (PRNT) | = 79/100 79.0% | 69.7 – 86.5% |
|---|---|---|
| Adjusted sensitivityf | = 88/99 88.9% | 81.0 – 94.3% |
Adjusted specificity and sensitivity calculations have been presented to reflect the presumptive redefinition of the specimens identified in " and " above.
Adjusted specificity: (9 endemic / IgG IFA positive specimens excluded and 10 PRNT positive / IgM ELISA positive / IgG IFA negative specimens included).
Adjusted sensitivity: (9 endemic / IgG IFA positive specimens included and 10 PRNT positive / IgM ELISA positive / IgG IFA negative specimens excluded).
2
Study Site 2:
Three hundred and twenty-five (325) retrospective sera from individuals of various ages and both genders were tested at a private reference laboratory in Utah, USA. The serum panel was comprised of 166 samples that were characterized positive and 159 samples that were characterized negative for WNV by IFA slides (ASR). Thirty-four of these samples were from patients with clinical symptoms consistent with encephalitis / meningitis, of which 32 were characterized positive and 2 were characterized negative for WNV by IFA. The samples were not masked and were tested by the PANBIO West Nile Virus IgG Indirect ELISA. Assay performance was determined by comparing PANBIO West Nile Virus IgG Indirect ELISA results with the clinical and serological characterization of the samples. The data is summarised in Table 2 and Table 3.
Table 2 - Study Site 2 PANBIO West Nile Virus IgG Indirect ELISA Reactivity with Encephalitis / Meningitis Patients
| Specimen | PANBIO IgG ELISA Results | |||
|---|---|---|---|---|
| Characterization | Pos | Eqva | Neg | Total |
| Encephalitis/ meningitis | ||||
| patients (IgG IFA positive) | 26 | 2 | 4 | 32 |
| Encephalitis/meningitis | ||||
| patients (IgG IFA negative) | 0 | 0 | 2 | 2 |
| Total | 26 | 2 | 6 | 34 |
8 Retesting of equivocals was not conducted as cut-off was modified following clinical trials.
| Encephalitic symptoms (IgG IFA positive) | 95% Confidence Interval | ||
|---|---|---|---|
| Positive Presumptive | |||
| Agreement | = 26/32 | 81.3% | 63.6 – 92.8% |
| WNV (presumptive by (lgG IFA negative )) | |||
| Negative Presumptive | |||
| Agreement | =2/2 | 100.0% | 15.8 – 100.0% |
Table 3 - Study Site 2 PANBIO West Nile Virus IgG Indirect ELISA Reactivity with WNV IFA Characterized Specimens
| Specimen Characterization | PANBIO IgG ELISA Results | |||
|---|---|---|---|---|
| Pos | Eqva | Neg | Total | |
| WNV positive | ||||
| (IgG IFA positive) | 146 | 5 | 15 | 166 |
| WNV negative | ||||
| (IgG IFA negative) | 15 | 4 | 140 | 159 |
| Total | 161 | 9 | 155 | 325 |
8 Retesting of equivocals was not conducted as cut-off was modified following clinical trials.
3
WNV IFA positive (presumptive)
| Positive Presumptive | ||
|---|---|---|
| Agreement | = 286/325 88.0% | 84.5 - 91.5% |
| Negative Presumptive | ||
| Agreement | = 140/159 88.1% | 83.0 - 93.1% |
Study Site 3:
Two-hundred and eighty-four (284) retrospective sera collected in 2002 from individuals of various ages and both genders were tested at a hospital laboratory in Ohio, USA. The sera included specimens from 89 patients with symptoms of encephalitis / meningitis (51 samples were confirmed positive for WN virus by PRNT and positive for IFA, and 38 samples were positive by IFA), and 195 randomly selected normal specimens from routine laboratory testing, negative for WN virus by IFA. These samples were masked and tested on the PANBIO West Nile Virus IgG Indirect ELISA and the results were compared to the clinical and serological characterisation of the samples to determine the performance of the assay. The data is summarised in Table 4.
Table 4 - Study Site 3 PANBIO West Nile Virus IqG Indirect ELISA Reactivity with Endemic Normal and Encephalitis / Meningitis Patients
| Specimen Characterization | PANBIO IgG ELISA Results | |||
|---|---|---|---|---|
| Pos | Eqva | Neg | Total | |
| Endemic normal specimens | ||||
| (randomly selected / IgG IFA negative)b | 10 | 5 | 180 | 195 |
| Encephalitis/meningitis patients | ||||
| (PRNT positive & IgG IFA positive)c | 41 | 1 | 9 | 51 |
| Encephalitis/meningitis patients | ||||
| (IgG IFA positive)c | 29 | 2 | 7 | 38 |
| Total | 80 | 8 | 196 | 284 |
Retesting of equivocals was not conducted as cut-off was modified following clinical trials.
· Endemic randomly selected specimens not known to have an arbovirus infection. All specimens
(n=195) further tested negative by PANBIO WNV IgG IFA ASR.
^ Encephalitis/meningitis patients. Specimens collected in 2002. Fifty-one samples were tested by WNV PRNT. All specimens (n=89) further tested positive by PANBIO WNV IgG IFA ASR.
95% Confidence Interval
| Endemic normal specimens | ||
|---|---|---|
| Negative Presumptive Agreement = 180/195 | 92.3% | 87.6 - 95.6% |
| Encephalitis/meningitis patients | ||
| Clinical sensitivity (PRNT) = 41/51 | 80.4% | 66.9 - 90.2% |
| Positive Presumptive Agreement = 29/38 | 76.3% | 59.8 - 88.6% |
4
REPRODUCIBILITY
The reproducibility of the PANBIO West Nile Virus IgG Indirect ELISA was determined by testing 8 sera 3 times each on 3 different assays at one Australian study site and two study sites in the USA. Within-run, between day, between site and total precision were estimated by Analysis of Variance (ANOVA) Type II. The results are presented in Table 5 below.
| Sample | n | *Mean | Within | Between Day | Between Site | Total | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| *SD | CV | *SD | CV | *SD | CV | *SD | CV | |||
| Reactive | 27 | 5.83 | 0.25 | 4.3% | 0.00 | 0.0% | 0.00 | 0.0% | 0.24 | 4.2% |
| Negative | 27 | 0.19 | 0.02 | 8.8% | 0.00 | 0.0% | 0.08 | 45.5% | 0.07 | 38.8% |
| #1 | 27 | 2.24 | 0.16 | 7.0% | 0.12 | 5.1% | 1.08 | 48.3% | 0.92 | 41.0% |
| #2 | 27 | 2.94 | 0.20 | 6.9% | 0.16 | 5.5% | 0.13 | 4.3% | 0.26 | 9.0% |
| #3 | 27 | 4.07 | 0.32 | 7.9% | 0.00 | 0.0% | 0.52 | 12.8% | 0.53 | 13.1% |
| #4 | 27 | 1.48 | 0.11 | 7.7% | 0.11 | 7.6% | 0.08 | 5.6% | 0.16 | 11.0% |
| #5 | 27 | 1.53 | 0.06 | 4.2% | 0.06 | 3.9% | 0.18 | 11.9% | 0.17 | 11.2% |
| #6 | 27 | 1.23 | 0.09 | 7.4% | 0.03 | 2.3% | 0.16 | 13.3% | 0.17 | 13.5% |
| #7 | 27 | 0.82 | 0.05 | 6.2% | 0.02 | 1.9% | 0.13 | 16.0% | 0.12 | 14.8% |
| #8 | 27 | 0.84 | 0.07 | 7.9% | 0.00 | 0.0% | 0.12 | 14.7% | 0.12 | 14.4% |
Table 5 - Reproducibility Data PANBIO West Nile Virus IgG Indirect ELISA Precision Measures - ANOVA Type II (Using Cut-Off Ratio*)
All values are calculated from Ratios *
SD = Standard Deviation; CV = Coefficient of Variation (%)
Notes:
- Standard deviation results have been rounded to two decimal places for tabulation purposes.
- The cut-off ratio * is calculated by dividing the sample absorbance by the cut-off value. The cut-off value is calculated by multiplying the average absorbance of the triplicates of the calibrator by the calibration factor. The calibrator cannot be calculated as a true cut-off ratio and therefore has been excluded from this analysis.
5
CROSS REACTIVITY
This study consisted of a panel of 314 specimens from patients with confirmed diseases other than WNV. The purpose of this study was to establish the analytical specificity of the PANBIO West Nile Virus IgG Indirect ELISA through the analysis of specimens with diseases that have the potential for cross-reactivity. Each of the specimens included in the study was characterised with respect to disease state prior to analysis of the specimens with the PANBIO West Nile Virus IgG Indirect ELISA. Table 6 below provides a summary of specimens in the disease panel outlined in Table 7.
| PANBIO West Nile virus IgG Indirect ELISA | ||||
|---|---|---|---|---|
| Disease State | Total | |||
| Specimensa | PANBIO IgG ELISA Results | |||
| Pos | Eqv | Pos and Eqv | ||
| Dengue virus | 15 | 14 | 0 | 14/15 |
| St. Louis encephalitis | 35 | 25 | 3 | 28/35 |
| Japanese encephalitis | 3 | 3 | 0 | 3/3 |
| La Crosse encephalitis | 26 | 2 | 0 | 2/26 |
| California encephalitis | 11 | 0 | 1 | 1/11 |
| Eastern Equine encephalitis | 1 | 0 | 0 | 0/1 |
| Varicella-Zoster virus | 15 | 0 | 0 | 0/15 |
| Cytomegalovirus | 48 | 7 | 0 | 7/48 |
| Epstein-Barr virus | 40 | 7 | 0 | 7/40 |
| Enterovirus | 15 | 1 | 0 | 1/15 |
| Ross River virus | 39 | 10 | 1 | 11/39b |
| Barmah Forest virus | 36 | 10 | 3 | 13/36c |
| Rheumatoid Factor | 15 | 4 | 0 | 4/15 |
| Anti-Nuclear Antibody | 15 | 2 | 0 | 2/15 |
| Table 6 - Summary of Cross-reactivity Analysis | |
|---|---|
| PANBIO West Nile Virus laG Indirect ELISA |
a Sample testing was conducted at PANBIO (Site 5) except as follows:
Site 1: Testing on 25 Saint Louis encephalitis, 9 California encephalitis and 1 Eastern Equine encephalitis specimens was conducted at a state health laboratory in Louisiana, USA,
Site 2: Testing on 5 Dengue virus, 10 Saint Louis encephalitis and 2 California encephalitis specimens was conducted at a private reference laboratory in Utah, USA.
Site 3: Testing on 26 La Crosse encephalitis specimens was conducted at a hospital laboratory in Ohio, USA.
Site 6: Testing on 25 Epstein-Barr virus and 33 Cytomegalovirus specimens was conducted at a private research laboratory in Maryland, USA.
6 11 of 11 samples that were reactive on PANBIO West Nile virus IgG Indirect ELISA were confirmed flavivirus positive by Western blot.
6 9 of 13 samples that were reactive on PANBIO West Nile virus IgG Indirect ELISA were confirmed flavivirus positive by Western blot.
6
| PANBIO West Nile Virus IgG Indirect ELISA | ||||
|---|---|---|---|---|
| Sample | Site * | IgG Antibody Type | PANBIO E-WNV01G | |
| ELISA Result | ||||
| Units | Result | |||
| 1 | 2 | Dengue virus | 25.6 | P |
| 2 | 2 | Dengue virus | 100.3 | P |
| 3 | 2 | Dengue virus | 5.1 | N |
| 4 | 2 | Dengue virus | 102.3 | P |
| 5 | 2 | Dengue virus | 82.7 | P |
| 6 | 5 | Dengue virus | 96.1 | P |
| 7 | 5 | Dengue virus | 103.6 | P |
| 8 | 5 | Dengue virus | 105.7 | P |
| 9 | 5 | Dengue virus | 114.7 | P |
| 10 | 5 | Dengue virus | 126.7 | P |
| 11 | 5 | Dengue virus | 102.5 | P |
| 12 | 5 | Dengue virus | 123.5 | P |
| 13 | 5 | Dengue virus | 116.6 | P |
| 14 | 5 | Dengue virus | 112.3 | P |
| 15 | 5 | Dengue virus | 118.6 | P |
| 16 | 1 | Saint Louis encephalitis | 15.6 | E |
| 17 | 1 | Saint Louis encephalitis | 21.4 | P |
| 18 | 1 | Saint Louis encephalitis | 4.2 | N |
| 19 | 1 | Saint Louis encephalitis | 8.7 | N |
| 20 | 1 | Saint Louis encephalitis | 18.2 | P |
| 21 | 1 | Saint Louis encephalitis | 28.9 | P |
| 22 | 1 | Saint Louis encephalitis | 35.9 | P |
| 23 | 1 | Saint Louis encephalitis | 40.5 | P |
| 24 | 1 | Saint Louis encephalitis | 1.2 | N |
| 25 | 1 | Saint Louis encephalitis | 28.2 | P |
| 26 | 1 | Saint Louis encephalitis | 7.8 | N |
| 27 | 1 | Saint Louis encephalitis | 27.0 | P |
| 28 | 1 | Saint Louis encephalitis | 47.8 | P |
| 29 | 1 | Saint Louis encephalitis | 43.0 | P |
| 30 | 1 | Saint Louis encephalitis | 57.2 | P |
| 31 | 1 | Saint Louis encephalitis | 47.9 | P |
| 32 | 1 | Saint Louis encephalitis | 29.4 | P |
| 33 | 1 | Saint Louis encephalitis | 31.0 | P |
| 34 | 1 | Saint Louis encephalitis | 16.5 | P |
| 35 | 1 | Saint Louis encephalitis | 43.1 | P |
| 36 | 1 | Saint Louis encephalitis | 68.5 | P |
| 37 | 1 | Saint Louis encephalitis | 59.5 | P |
| 38 | 1 | Saint Louis encephalitis | 10.0 | N |
| Sample Site * | IgG Antibody Type | PANBIO E-WNV01G | ||
| ELISA Result | ||||
| Units | Result | |||
| 39 | Saint Louis encephalitis | 13.4 | N | |
| 40 | Saint Louis encephalitis | 54.6 | P | |
| 41 | Saint Louis encephalitis | 15.4 | E | |
| 42 | Saint Louis encephalitis | 15.7 | E | |
| 43 | Saint Louis encephalitis | 41.6 | P | |
| 44 | Saint Louis encephalitis | 6.0 | N | |
| 45 | Saint Louis encephalitis | 73.6 | P | |
| 46 | Saint Louis encephalitis | 32.6 | P | |
| 47 | Saint Louis encephalitis | 79.1 | P | |
| 48 | Saint Louis encephalitis | 62.8 | P | |
| 49 | Saint Louis encephalitis | 32.8 | P | |
| 50 | Saint Louis encephalitis | 25.3 | P | |
| 51 | Japanese encephalitis | 66.0 | P | |
| 52 | Japanese encephalitis | 41.6 | P | |
| 53 | Japanese encephalitis | 103.9 | P | |
| 54 | La Crosse encephalitis | 2.1 | N | |
| 55 | La Crosse encephalitis | 1.8 | N | |
| 56 | La Crosse encephalitis | 3.6 | N | |
| 57 | La Crosse encephalitis | 2.1 | N | |
| 58 | La Crosse encephalitis | 16.5 | P | |
| 59 | La Crosse encephalitis | 4.4 | N | |
| 60 | La Crosse encephalitis | 5.8 | N | |
| 61 | La Crosse encephalitis | 2.5 | N | |
| 62 | La Crosse encephalitis | 1.9 | N | |
| 63 | La Crosse encephalitis | 3.2 | N | |
| 64 | La Crosse encephalitis | 2.2 | N | |
| 65 | La Crosse encephalitis | 2.2 | N | |
| 66 | La Crosse encephalitis | 2.8 | N | |
| 67 | La Crosse encephalitis | 2.2 | N | |
| 68 | La Crosse encephalitis | 1.3 | N | |
| 69 | La Crosse encephalitis | 3 | N | |
| 70 | La Crosse encephalitis | 5.5 | N | |
| 71 | La Crosse encephalitis | 6.4 | N | |
| 72 | La Crosse encephalitis | 3.6 | N | |
| 73 | La Crosse encephalitis | 3.6 | N | |
| 74 | La Crosse encephalitis | 13.2 | N | |
| 75 | La Crosse encephalitis | 1.7 | N | |
| 76 | La Crosse encephalitis | 5.4 | N | |
| Sample | Site * | IgG Antibody Type | PANBIO E-WNV01G | |
| ELISA Result | ||||
| Units | Result | |||
| 77 | 3 | La Crosse encephalitis | 2.5 | N |
| 78 | 3 | La Crosse encephalitis | 6 | N |
| 79 | 3 | La Crosse encephalitis | 16.8 | P |
| 80 | 1 | California encephalitis | 6.1 | N |
| 81 | 1 | California encephalitis | 11.5 | N |
| 82 | 1 | California encephalitis | 14.1 | E |
| 83 | 1 | California encephalitis | 1.5 | N |
| 84 | 1 | California encephalitis | 5.4 | N |
| 85 | 1 | California encephalitis | 8.5 | N |
| 86 | 1 | California encephalitis | 6.2 | N |
| 87 | 1 | California encephalitis | 4 | N |
| 88 | 1 | California encephalitis | 4.7 | N |
| 89 | 2 | California encephalitis | 13.2 | N |
| 90 | 2 | California encephalitis | 4.4 | N |
| 91 | 1 | Eastern Equine enceph. | 3.6 | N |
| 92 | 5 | Varicella-Zoster virus | 3.7 | N |
| 93 | 5 | Varicella-Zoster virus | 2.4 | N |
| 94 | 5 | Varicella-Zoster virus | 5.7 | N |
| 95 | 5 | Varicella-Zoster virus | 5.3 | N |
| 96 | 5 | Varicella-Zoster virus | 3.8 | N |
| 97 | 5 | Varicella-Zoster virus | 7.7 | N |
| 98 | 5 | Varicella-Zoster virus | 2.6 | N |
| 99 | 5 | Varicella-Zoster virus | 3.8 | N |
| 100 | 5 | Varicella-Zoster virus | 10.0 | N |
| 101 | 5 | Varicella-Zoster virus | 1.2 | N |
| 102 | 5 | Varicella-Zoster virus | 2.2 | N |
| 103 | 5 | Varicella-Zoster virus | 2.5 | N |
| 104 | 5 | Varicella-Zoster virus | 6.7 | N |
| 105 | 5 | Varicella-Zoster virus | 2.6 | N |
| 106 | 5 | Varicella-Zoster virus | 3.9 | N |
| 107 | 5 | Cytomegalovirus | 4.6 | N |
| 108 | 5 | Cytomegalovirus | 1.5 | N |
| 109 | 5 | Cytomegalovirus | 1.9 | N |
| 110 | 5 | Cytomegalovirus | 1.8 | N |
| 111 | 5 | Cytomegalovirus | 16.7 | P |
| 112 | 5 | Cytomegalovirus | 4.4 | N |
| 113 | 5 | Cytomegalovirus | 1.9 | N |
| 114 | 5 | Cytomegalovirus | 44.5 | P |
| Sample | Site * | IgG Antibody Type | PANBIO E-WNV01G | |
| ELISA Result | ||||
| Units | Result | |||
| 115 | 5 | Cytomegalovirus | 69.4 | P |
| 116 | 5 | Cytomegalovirus | 5.2 | N |
| 117 | 5 | Cytomegalovirus | 3.8 | N |
| 118 | 5 | Cytomegalovirus | 46.9 | P |
| 119 | 5 | Cytomegalovirus | 16.2 | P |
| 120 | 5 | Cytomegalovirus | 3.3 | N |
| 121 | 5 | Cytomegalovirus | 31.0 | P |
| 122 | 6 | Cytomegalovirus | 11.9 | N |
| 123 | 6 | Cytomegalovirus | 0.5 | N |
| 124 | 6 | Cytomegalovirus | 0.3 | N |
| 125 | 6 | Cytomegalovirus | 3.7 | N |
| 126 | 6 | Cytomegalovirus | 1.3 | N |
| 127 | 6 | Cytomegalovirus | 0.6 | N |
| 128 | 6 | Cytomegalovirus | 2.9 | N |
| 129 | 6 | Cytomegalovirus | 1.1 | N |
| 130 | 6 | Cytomegalovirus | 2.1 | N |
| 131 | 6 | Cytomegalovirus | 4.4 | N |
| 132 | 6 | Cytomegalovirus | 4.1 | N |
| 133 | 6 | Cytomegalovirus | 1.4 | N |
| 134 | 6 | Cytomegalovirus | 0.4 | N |
| 135 | 6 | Cytomegalovirus | 7.8 | N |
| 136 | 6 | Cytomegalovirus | 4.9 | N |
| 137 | 6 | Cytomegalovirus | 11.6 | N |
| 138 | 6 | Cytomegalovirus | 20.4 | P |
| 139 | 6 | Cytomegalovirus | 7.5 | N |
| 140 | 6 | Cytomegalovirus | 0.8 | N |
| 141 | 6 | Cytomegalovirus | 2.2 | N |
| 142 | 6 | Cytomegalovirus | 12.1 | N |
| 143 | 6 | Cytomegalovirus | 4.4 | N |
| 144 | 6 | Cytomegalovirus | 9.8 | N |
| 145 | 6 | Cytomegalovirus | 1.3 | N |
| 146 | 6 | Cytomegalovirus | 0.5 | N |
| 147 | 6 | Cytomegalovirus | 2.8 | N |
| 148 | 6 | Cytomegalovirus | 1.3 | N |
| 149 | 6 | Cytomegalovirus | 1.7 | N |
| 150 | 6 | Cytomegalovirus | 0.4 | N |
| 151 | 6 | Cytomegalovirus | 5.5 | N |
| 152 | 6 | Cytomegalovirus | 3.4 | N |
| Sample | Site * | IgG Antibody Type | PANBIO E-WNV01G | |
| ELISA Result | ||||
| Units | Result | |||
| 153 | 6 | Cytomegalovirus | 0.6 | N |
| 154 | 6 | Cytomegalovirus | 6.2 | N |
| 155 | 5 | Epstein-Barr virus | 3.3 | N |
| 156 | 5 | Epstein-Barr virus | 2.0 | N |
| 157 | 5 | Epstein-Barr virus | 3.8 | N |
| 158 | 5 | Epstein-Barr virus | 2.4 | N |
| 159 | 5 | Epstein-Barr virus | 18.0 | P |
| 160 | 5 | Epstein-Barr virus | 5.5 | N |
| 161 | 5 | Epstein-Barr virus | 1.9 | N |
| 162 | 5 | Epstein-Barr virus | 19.9 | P |
| 163 | 5 | Epstein-Barr virus | 2.3 | N |
| 164 | 5 | Epstein-Barr virus | 6.7 | N |
| 165 | 5 | Epstein-Barr virus | 3.4 | N |
| 166 | 5 | Epstein-Barr virus | 17.9 | P |
| 167 | 5 | Epstein-Barr virus | 6.6 | N |
| 168 | 5 | Epstein-Barr virus | 134.2 | P |
| 169 | 5 | Epstein-Barr virus | 3.2 | N |
| 170 | 6 | Epstein-Barr virus | 10.2 | N |
| 171 | 6 | Epstein-Barr virus | 4.6 | N |
| 172 | 6 | Epstein-Barr virus | 5.8 | N |
| 173 | 6 | Epstein-Barr virus | 5.8 | N |
| 174 | 6 | Epstein-Barr virus | 17.4 | P |
| 175 | 6 | Epstein-Barr virus | 7.4 | N |
| 176 | 6 | Epstein-Barr virus | 5.1 | N |
| 177 | 6 | Epstein-Barr virus | 5.5 | N |
| 178 | 6 | Epstein-Barr virus | 29.0 | P |
| 179 | 6 | Epstein-Barr virus | 6.5 | N |
| 180 | 6 | Epstein-Barr virus | 5.6 | N |
| 181 | 6 | Epstein-Barr virus | 3.4 | N |
| 182 | 6 | Epstein-Barr virus | 4.0 | N |
| 183 | 6 | Epstein-Barr virus | 1.9 | N |
| 184 | 6 | Epstein-Barr virus | 50.0 | P |
| 185 | 6 | Epstein-Barr virus | 2.8 | N |
| 186 | 6 | Epstein-Barr virus | 12.3 | N |
| 187 | 6 | Epstein-Barr virus | 6.0 | N |
| 188 | 6 | Epstein-Barr virus | 8.9 | N |
| 189 | 6 | Epstein-Barr virus | 2.0 | N |
| 190 | 6 | Epstein-Barr virus | 3.3 | N |
| Sample | Site * | IgG Antibody Type | PANBIO E-WNV01G | |
| ELISA Result | ||||
| Units | Result | |||
| 191 | 6 | Epstein-Barr virus | 12.3 | N |
| 192 | 6 | Epstein-Barr virus | 13.9 | N |
| 193 | 6 | Epstein-Barr virus | 4.8 | N |
| 194 | 6 | Epstein-Barr virus | 6.0 | N |
| 195 | 5 | Enterovirus | 2.6 | N |
| 196 | 5 | Enterovirus | 7.0 | N |
| 197 | 5 | Enterovirus | 1.3 | N |
| 198 | 5 | Enterovirus | 4.7 | N |
| 199 | 5 | Enterovirus | 1.7 | N |
| 200 | 5 | Enterovirus | 6.1 | N |
| 201 | 5 | Enterovirus | 2.9 | N |
| 202 | 5 | Enterovirus | 1.8 | N |
| 203 | 5 | Enterovirus | 2.6 | N |
| 204 | 5 | Enterovirus | 1.2 | N |
| 205 | 5 | Enterovirus | 1.6 | N |
| 206 | 5 | Enterovirus | 3.5 | N |
| 207 | 5 | Enterovirus | 17.7 | P |
| 208 | 5 | Enterovirus | 2.8 | N |
| 209 | 5 | Enterovirus | 8.5 | N |
| 210 | 5 | Ross River virus | 95.8 | Pᵃ |
| 211 | 5 | Ross River virus | 12.5 | N |
| 212 | 5 | Ross River virus | 22.6 | Pᵃ |
| 213 | 5 | Ross River virus | 4.3 | N |
| 214 | 5 | Ross River virus | 8.6 | N |
| 215 | 5 | Ross River virus | 3.2 | N |
| 216 | 5 | Ross River virus | 6.2 | N |
| 217 | 5 | Ross River virus | 5.8 | N |
| 218 | 5 | Ross River virus | 30.4 | Pᵃ |
| 219 | 5 | Ross River virus | 7.3 | N |
| 220 | 5 | Ross River virus | 3.0 | N |
| 221 | 5 | Ross River virus | 4.4 | N |
| 222 | 5 | Ross River virus | 17.9 | Pᵃ |
| 223 | 5 | Ross River virus | 12.7 | N |
| 224 | 5 | Ross River virus | 4.9 | N |
| 225 | 5 | Ross River virus | 19.7 | Pᵃ |
| 226 | 5 | Ross River virus | 5.6 | N |
| 227 | 5 | Ross River virus | 5.0 | N |
| 228 | 5 | Ross River virus | 7.1 | N |
| PANBIO E-WNV01G | ||||
| Sample | Site * | IgG Antibody Type | ELISA Result | |
| Units | Result | |||
| 229 | 5 | Ross River virus | 38.9 | Pa |
| 230 | 5 | Ross River virus | 12.3 | N |
| 231 | 5 | Ross River virus | 6.5 | N |
| 232 | 5 | Ross River virus | 15.8 | Ea |
| 233 | 5 | Ross River virus | 9.3 | N |
| 234 | 5 | Ross River virus | 16.3 | Pa |
| 235 | 5 | Ross River virus | 12.6 | N |
| 236 | 5 | Ross River virus | 6.1 | N |
| 237 | 5 | Ross River virus | 4.8 | N |
| 238 | 5 | Ross River virus | 5.4 | N |
| 239 | 5 | Ross River virus | 8.1 | N |
| 240 | 5 | Ross River virus | 7.1 | N |
| 241 | 5 | Ross River virus | 16.1 | Pa |
| 242 | 5 | Ross River virus | 8.1 | N |
| 243 | 5 | Ross River virus | 7.9 | N |
| 244 | 5 | Ross River virus | 6.8 | N |
| 245 | 5 | Ross River virus | 60.8 | Pa |
| 246 | 5 | Ross River virus | 10.1 | N |
| 247 | 5 | Ross River virus | 6.9 | N |
| 248 | 5 | Ross River virus | 17.5 | Pa |
| 249 | 5 | Barmah forest virus | 5.9 | N |
| 250 | 5 | Barmah forest virus | 8.1 | N |
| 251 | 5 | Barmah forest virus | 15.7 | Ea |
| 252 | 5 | Barmah forest virus | 9.7 | N |
| 253 | 5 | Barmah forest virus | 11.6 | N |
| 254 | 5 | Barmah forest virus | 5.8 | N |
| 255 | 5 | Barmah forest virus | 4.6 | N |
| 256 | 5 | Barmah forest virus | 4.9 | N |
| 257 | 5 | Barmah forest virus | 7.5 | N |
| 258 | 5 | Barmah forest virus | 2.5 | N |
| 259 | 5 | Barmah forest virus | 12.5 | N |
| 260 | 5 | Barmah forest virus | 34.9 | Pa |
| 261 | 5 | Barmah forest virus | 8.0 | N |
| 262 | 5 | Barmah forest virus | 98.0 | Pa |
| 263 | 5 | Barmah forest virus | 9.3 | N |
| 264 | 5 | Barmah forest virus | 10.9 | N |
| 265 | 5 | Barmah forest virus | 10.6 | N |
| 266 | 5 | Barmah forest virus | 8.8 | N |
| Sample | Site * | IgG Antibody Type | PANBIO E-WNV01G | |
| ELISA Result | ||||
| Units | Result | |||
| 267 | 5 | Barmah forest virus | 55.2 | Pa |
| 268 | 5 | Barmah forest virus | 6.4 | N |
| 269 | 5 | Barmah forest virus | 8.8 | N |
| 270 | 5 | Barmah forest virus | 8.8 | N |
| 271 | 5 | Barmah forest virus | 52.4 | Pa |
| 272 | 5 | Barmah forest virus | 10.4 | N |
| 273 | 5 | Barmah forest virus | 19.5 | Pa |
| 274 | 5 | Barmah forest virus | 6.2 | N |
| 275 | 5 | Barmah forest virus | 9.0 | N |
| 276 | 5 | Barmah forest virus | 5.5 | N |
| 277 | 5 | Barmah forest virus | 26.0 | P |
| 278 | 5 | Barmah forest virus | 27.6 | Pa |
| 279 | 5 | Barmah forest virus | 14.2 | E |
| 280 | 5 | Barmah forest virus | 34.3 | P |
| 281 | 5 | Barmah forest virus | 6.2 | N |
| 282 | 5 | Barmah forest virus | 79.1 | Pa |
| 283 | 5 | Barmah forest virus | 49.7 | P |
| 284 | 5 | Barmah forest virus | 14.4 | Ea |
| 285 | 5 | Rheumatoid Factor | 16.3 | P |
| 286 | 5 | Rheumatoid Factor | 2.5 | N |
| 287 | 5 | Rheumatoid Factor | 6.4 | N |
| 288 | 5 | Rheumatoid Factor | 5.0 | N |
| 289 | 5 | Rheumatoid Factor | 21.3 | P |
| 290 | 5 | Rheumatoid Factor | 1.4 | N |
| 291 | 5 | Rheumatoid Factor | 3.6 | N |
| 292 | 5 | Rheumatoid Factor | 3.9 | N |
| 293 | 5 | Rheumatoid Factor | 7.1 | N |
| 294 | 5 | Rheumatoid Factor | 4.6 | N |
| 295 | 5 | Rheumatoid Factor | 45.2 | P |
| 296 | 5 | Rheumatoid Factor | 7.5 | N |
| 297 | 5 | Rheumatoid Factor | 36.5 | P |
| 298 | 5 | Rheumatoid Factor | 4.5 | N |
| 299 | 5 | Rheumatoid Factor | 4.5 | N |
| 300 | 5 | Anti-Nuclear Antibody | 2.88 | N |
| 301 | 5 | Anti-Nuclear Antibody | 1.94 | N |
| 302 | 5 | Anti-Nuclear Antibody | 1.28 | N |
| 303 | 5 | Anti-Nuclear Antibody | 7.04 | N |
| 304 | 5 | Anti-Nuclear Antibody | 4.07 | N |
| Sample | Site * | IgG Antibody Type | PANBIO E-WNV01G | |
| ELISA Result | ||||
| Units | Result | |||
| 305 | 5 | Anti-Nuclear Antibody | 5.63 | N |
| 306 | 5 | Anti-Nuclear Antibody | 13.33 | N |
| 307 | 5 | Anti-Nuclear Antibody | 8.2 | N |
| 308 | 5 | Anti-Nuclear Antibody | 48.9 | P |
| 309 | 5 | Anti-Nuclear Antibody | 2.6 | N |
| 310 | 5 | Anti-Nuclear Antibody | 7.2 | N |
| 311 | 5 | Anti-Nuclear Antibody | 3.5 | N |
| 312 | 5 | Anti-Nuclear Antibody | 6.1 | N |
| 313 | 5 | Anti-Nuclear Antibody | 50.0 | P |
| 314 | 5 | Anti-Nuclear Antibody | 2.1 | N |
Table 7 – Results of Cross-reactivity Analysis
PANBIO West Nile Virus IgG Indirect ELISA
7
Table 7 – Results of Cross-reactivity Analysis – Continued
8
Table 7 – Results of Cross-reactivity Analysis – Continued
9
Table 7 – Results of Cross-reactivity Analysis – Continued
10
Table 7 – Results of Cross-reactivity Analysis – Continued
11
Table 7 -- Results of Cross-reactivity Analysis -- Continued
12
Table 7 – Results of Cross-reactivity Analysis – Continued
13
Table 7 – Results of Cross-reactivity Analysis – Continued
14
Table 7 – Results of Cross-reactivity Analysis – Continued
a Flavivirus reactivity in these samples has been confirmed by Western blot analysis.
INTERPRETATION
| AN R A. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B. B
Buch Bandade | |
CHANNELE AND LE CHANNEL CALL
A BROND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AN | |
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WHERE ANNUAL A COLL L A & A |
- Refer to summary table for explanation of sites.
.
15
Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is a stylized symbol that resembles three parallel lines curving upwards, often interpreted as representing human aspiration and progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 0 2004
Ms. Jillianne Keller Regulatory Affairs Officer PANBIO Limited. 116 Lutwyche Road, Windsor Brisbane, Queensland 4030 Australia
K041068 Re:
Trade/Device Name: West Nile Virus IgG Indirect ELISA Regulation Number: 21 CFR 866.3940 Regulation Name: West Nile Virus Serological Reagents Regulatory Class: Class II Product Code: NOP Dated: September 17, 2004 Received: September 20, 2004
Dear Ms. Keller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conniner of the 112) 2011-12-11 in accordance with the provisions of the Federal Food, Drug, de vices may been recial of require approval of a premarket approval application (PMA). and Cosmetic rear (110) market the device, subject to the general controls provisions of the Act. The I ou may, dicrere, mance of the Act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may be subject to back adon additions (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Drimination that your device complies with other requirements of the Act that I DIT has made a and regulations administered by other Federal agencies. You must or any it cach statutes and regarments, including, but not limited to: registration and listing (21 compry with an the Tre (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
16
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Saartys
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
17
Indications for Use
20 October, 2004
510(k) Number (if known):_K041068
Device Name: West Nile Virus IgG Indirect ELISA
Indications For Use:
The PANBIO West Nile Virus IgG Indirect ELISA is for the qualitative presumptive detection of IgG antibodies to West Nile virus in serum. In conjunction with the PANBIO West Nile Virus IgM Capture ELISA, this test is intended as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis. 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.
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________ KOFIDER