Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ELISA assay and does not mention any AI or ML components in the device description, intended use, or performance studies.

Therapeutic

No
This device is for diagnostic purposes (detection of West Nile virus antibodies), not for treatment or therapy.

Diagnostic

Yes
The device is described as aiding in the clinical laboratory diagnosis of West Nile virus infection by detecting IgM antibodies. This directly relates to diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an Enzyme Linked Immunosorbent Assay (ELISA), which is a laboratory test method involving physical reagents and equipment, not solely software.

IVD (In Vitro Diagnostic)

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 IoM antibodies to West Nile virus in serum 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) for diagnostic purposes.
Device Description: The "Device Description" further reinforces this by describing it as an "Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis". ELISA is a common in vitro diagnostic technique.
Intended User / Care Setting: The intended user is a "Clinical laboratory", which is where in vitro diagnostic tests are performed.

All these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PANBIO West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IoM antibodies to West Nile virus in serum 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.

Caution: Cross-reactivity has been noted with the PANBIO West Nile IgM assay in specimens containing rheumatoid factor (RF). Reactive results must be reported with a caution statement regarding possible cross-reactivity with RF.

Product codes (comma separated list FDA assigned to the subject device)

NOP

Device Description

The West Nile Virus IgM Capture ELISA is an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus 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

Not Found

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: Four hundred and twenty (420) retrospective sera from individuals of various ages and both genders were tested at PANBIO, a reference center in California, USA, 115 endemic negative endemic samples from a private reference laboratory in Maryland, USA, 132 specimens from specimens from a private reference laboratory in Utah, USA, 26 patients from patients presenting for WNV testing at a university medical branch in Texas, Specimens from patients presenting for WNV testing from a private laboratory in USA, and 20 specimens from patients from Minnesota, USA. Of those samples, 130 were pre-characterized by PRNT, 73 had CDC MAC. These samples were subsequently tested on the PANBIO West Nile Virus IgM Capture ELISA to determine assay performance.

Study Site 2: Fifty-one (51) retrospective sera from individuals of various ages and both genders, collected in 2002 and confirmed by PRNT for WNV antibodies, were tested at a hospital laboratory in Ohio, USA. The results were compared to the PANBIO West Nile Virus IgM test and PRNT results to determine the performance of the assay.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Site 1 Reactivity with PRNT

Sample size: 130
WNV positive (confirmed by PRNT): 61 (59 Pos, 0 Eqv, 2 Neg)
WNV negative (confirmed by PRNT): 69 (9 Pos, 1 Eqv, 59 Neg)
Total: 130 (68 Pos, 1 Eqv, 61 Neg)
Serological sensitivity: 59/61 = 96.7% (95% CI: 88.7 – 99.6%)
Serological specificity: 59/69 = 85.5% (95% CI: 75.0 - 92.8%)

Study Site 1 Reactivity with CDC MAC EIA Presumptively Characterized Specimens

Sample size: 73
WNV positive (presumptive by CDC MAC EIA): 11 (11 Pos, 0 Eqv, 0 Neg)
WNV negative (presumptive by CDC MAC EIA): 62 (1 Pos, 0 Eqv, 61 Neg)
Total: 73 (12 Pos, 0 Eqv, 61 Neg)
Positive agreement: 11/11 = 100% (95% CI: 71.5 – 100%)
Negative agreement: 61/62 = 98.4% (95% CI: 91.3 – 100%)

Study Site 1 Reactivity with IgM IFA

Sample size: 419
WNV positive (presumptive by WNV IgM IFA): 96 (86 Pos, 0 Eqv, 10 Neg)
Indeterminate: 23 (7 Pos, 0 Eqv, 16 Neg)
WNV negative: 300 (3 Pos, 1 Eqv, 296 Neg)
Total: 419 (96 Pos, 1 Eqv, 322 Neg)
Positive agreement: 86/112 = 76.7% (IgM positive + indeterminate by IFA assigned to IgM positive category for calculation) (95% CI: 69.0 - 84.6%)
Negative agreement: 296/307 = 96.4% (IgM negative + indeterminate by IFA assigned to IgM negative category for calculation) (95% CI: 93.7 – 98.2%)

Study Site 2 Reactivity with Encephalitis / Meningitis Patient and Endemic Patient Specimens

Sample Size: 51
Encephalitis / meningitis patients (E-WNV01M & PRNT positive): 51 Pos, 0 Eqv, 0 Neg
Clinical sensitivity (with PRNT): 51/51 = 100.0% (95% CI: 93.0 - 100.0%)
An additional six acute serum specimens with CSF anti-WNV IgM, but without PRNT information, tested negative with PANBIO WNV IgM test.

Specificity of IgM Detection

Study with 10 serum samples with varying levels of IgM antibodies, treated with 0.005M Dithiothreitol (DTT) to remove IgM. Significant decrease in absorbance after DTT treatment.
Study with 8 serum samples with known levels of IgM and IgG antibodies to WNV, treated with goat anti-human IgG absorbent. No effect on IgM reactivity.
Indication: Assay is specific for IgM antibodies and specific WNV IgG antibodies do not interfere.

Effects of Freeze-Thaw Cycles

Study with 8 serum samples with varying levels of IgM antibodies to WNV.
Indicates: five freeze-thaw cycles have little effect on IgM detection; recommended up to three freeze-thaw cycles for testing.

Reproducibility Study (Three Sites)

Sample size: 27 for each sample type (Positive, Cut-off, Negative, and 8 individual samples #1 to #8).
Measures included Mean, Within, Between Day, Between Site, and Total Standard Deviation (S.D.) and Coefficient of Variation (CV).

Cross Reactivity

Study consisted of a panel of 160 specimens from patients with confirmed diseases other than WNV.
Diseases included: 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.
Total Reactive: 6/160 (3.8%)
Specific findings:
- Dengue virus: 2/16 (12.5%) reactive
- Rheumatoid Factor: 4/15 (26.7%) reactive

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Serological sensitivity = 96.7%
Serological specificity = 85.5%
Positive agreement = 100%
Negative agreement = 98.4%
Positive agreement (with IgM IFA) = 76.7%
Negative agreement (with IgM IFA) = 96.4%
Clinical sensitivity (with PRNT) = 100.0%

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.

K031703

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

Regulation Number and Section

§ 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.

Summary

0

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 1.9

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: To be allocated

Applicant Information:

Submission Date:	6th May 2004
Date Modified:	5th August 2004
Name:	PANBIO Limited
Address:	116 Lutwyche Road, Windsor
Queensland 4030 Australia
Contact Person:	Craig Breadmore / Kate Wersin
Phone Number:
Fax Number:	+61-(0)7-3357-1177
+61-(0)7-3357-1222

Device Information:

Trade Name:	West Nile Virus IgM Capture ELISA
Common Name:	West Nile Virus IgM Capture EIA Test
Classification Name:	West Nile virus, serological reagents (21 CFR 866.3940)

Equivalent Device:

Equivalence to the PANBIO West Nile Virus IgM Capture ELISA (E-WNV01M -510(k): K031703) is claimed and shall be demonstrated via the enclosed performance data. The PANBIO West Nile Virus IgM Capture ELISA, E-WNV02M, is identical in intended use to the 510(k)-cleared E-WNV01M device. Modifications to the E-WNV02M antigen and conjugate format have resulted in improved performance of the device. The re-designed E-WNV02M device in this submission is intended to supersede the E-WNV01M 510(k)-cleared version on the US market.

Device Description:

The West Nile Virus IgM Capture ELISA is an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus in patients with clinical symptoms consistent with encephalitis / meningitis.

Intended Use:

The PANBIO West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IoM antibodies to West Nile virus in serum 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.

Caution: Cross-reactivity has been noted with the PANBIO West Nile IgM assay in specimens containing rheumatoid factor (RF). Reactive results must be reported with a caution statement regarding possible cross-reactivity with RF.

1

Principle of Procedure:

Principle of Procedure.
Serum antibodies of the IgM class combine with antibodies attached to the Serum antibodies of the igin cluse of the ray plate). Residual serum is removed from the management polysiyrene Surface of the microwen toor only polity the conjugated monoclonal the "assay" plate" by "washing" write" and on the microwells are washed and anubody (Mab) is added to the usedy plater Piter Readen (TMB/H2O2) is added. a Coloness Substrate of Chan LEP, if present, and the chromogen changes to a blue The Substrate is Tiyuloryzon by the Than in process, the TMB becomes yellow. Color development is color: "Alter Stopping the roll WNV antibodies in the test sample.

PERFORMANCE CHARACTERISTICS

Study Site 1:

Four hundred and twenty (420) retrospective sera from individuals of various ages and both Pour hundred and twenty (420) relieved included samples from the following groups: 121 genders were tostod at PARCET on center in California, USA, 115 endemic negative endemic sumples from a private reference laboratory in Maryland, USA, 132 specimens from specifiens from a private reference laboratory in Utah, USA, 26 patiens from patients presenting for WNV testing at a university medical branch in Texas, Specimens from patients presenting for WNV testing from a private laboratory in OUA, and 20 spoolinene from pales 130 were pre-characterized by PRNT, 73 had CDC MAC Minnesola, Ook. Of those samples These samples were subsequently tested on the PANBIO West Nile Virus IgM Capture ELISA to determine assay performance. The data is summarized in Tables 1, 2 and 3.

| Specimen Characterization b

(Confirmed by PRNT)	PANBIO IgM ELISA Result
	Pos	Eqv a	Neg	Total
WNV positive	59	0	2d	61
WNV negative	9c	1	59	69
Total	68	1	61	130

Table 1 - Study Site 1 Reactivity with PRNT

Table 2 - Study Site 1 Reactivity with CDC MAC EIA umptively Characterized Specimens

Specimen Characterization °	PANBIO IgM ELISA Result
(Presumptive by CDC MAC EIA)	Pos	Eqv a	Neg	Total
WNV positive	11	0	0	11
WNV negative	1	0	61	62
Total	12	0	61	73

2

| Specimen Characterization

(Presumptive by WNV IgM IFA)f	PANBIO IgM ELISA Result
	Pos	Eqva	Neg	Total
WNV positive	86	0	10	96
Indeterminateg	7h	0	16i	23
WNV negative	3	1	296	300
Total	96	1	322	419

Table 3 - Study Site 1 Reactivity with IgM IFA

a Equivocal samples were not repeated.

" Equirosa campion in a blood donation centre in California, USA, and a government medical laboratory in Canada.

1 MNV RRNT negative / PANBIO JgM ELISA positive: Further investigation of the discrepant nature of these samples identified that most (7/9) were presumptively IgM positive (CDC MAC EIA = 2, IgM IFA ASR = 5).

deemiled that hour (110) Welcompany wither investigation of the discrepant nature identified that these samples (n=2) were presumptively IgM negative (CDC MAC EIA = 1, IgM IFA ASR = 1).

® CDC MAC EIA testing conducted at PANBIO.

1 FA testing conducted at PANBIO and a private reference laboratory in Utah, USA using the PANBIO IgM IFA ASR.

If A result Conduction of ANDRO and a pinctioninate results. This was the product of non-specific staining yelding an unacceptably high background making it not possible to make a reliable interpretation.

yelling an anaooopiday ingh bangreamal were further characterised by PRNT with 5 yielding a positive reaction and 2 a

negative reaction.
' Fifteen of the 16 sera were tested by MAC ELISA and yielded a negative result. Six of these 15 sera were tested by PRNT and yielded negative reactions. The one sample not tested by MAC ELISA tested negative by PRNT.

WNV (confirmed by PRNT)		95% CI*
Serological sensitivity = 59/61	96.7%	88.7 – 99.6%
Serological specificity = 59/69	85.5%	75.0 - 92.8%
WNV (presumptive by CDC MAC EIA)
Positive agreement = 11/11	100%	71.5 – 100%
Negative agreement = 61/62	98.4%	91.3 – 100%
WNV (presumptive by IgM IFA)
Positive agreement1 = 86/112	76.7%	69.0 - 84.6%
Negative agreement2 = 296/307	96.4%	93.7 – 98.2%

1 The 16 samples testing indeterminate by IFA and negative by the PANBIO WNV IgM were intentionally assigned to the "IgM positive" category for the purpose of this calculation yielding a worst-case scenario.

2 The 7 samples testing indeterminate by IFA and positive by the PANBIO WNV IgM were intentionally assigned to the "IgM negative" category for the purpose of this calculation yielding a worst-case scenario.

nugative "daogory for the parpose of the conspecific staining. If indeterminate samples were eliminated from the data set the positive agreement would be 89.6% (Cl 81.7 - 94.9%) and the negative agreement 98.7% (Cl 96.6 - 99.6%).

*CI = Exact confidence interval

3

Study Site 2

Study Site 2 Filly-one (51) Tellospective Serient patient was a hospital laboratory in Ohio, USA.
confirmed by PRNT for WNV antibodies, were tested at a hospital laboratory in Ohio, USA. conlimed by PRNT for WNV antibodios, were were and both genders in 2002 and tested The sera were collected from Individually of Various agos an interesults were compared to the In 2004 on the 1 ANDIO Wood mis as a most and secure to determine the performance of the assay. The data is summarized in Table 4.

| Table 4 – Study Site 2
Reactivity with Encephalitis / Meningitis Patient

and Endemic Patient Specimens
Specimen Characterization	PANBIO IgM ELISA Result
(E-WNV02M)	Pos	Eqv	Neg	Total
Encephalitis / meningitis patients
(E-WNV01M & PRNT positive)a		51	0	0	51

2 Encephalitis / meningting C TRIT pocking of the Pool in 2002. Samples were tested by WNV PRNT and further tested on the E-WNV02M device.

Encephalitis / meningitis patients (documented WNV infection by PRNT)

		95% CI*
Clinical sensitivity (with PRNT) = 51/51	100.0%	93.0 - 100.0%

*CI = Exact confidence interval

An additional six acute serum specimens, without PRNT information, from individuals with /in additional of encephalitis who had evidence of specific anti-WNV IgM being present in CSF were tested. Due to anti-WNV IgM being present in CSF these individuals were in Oor word to have WNV associated-encephalitis. When the serum specimens were tested with the PANBIO WNV IgM test all specimen results were negative.

SPECIFICITY OF IgM DETECTION

A study consisting of 10 serum samples with varying levels of IgM antibodies was conducted A study of lot of to of to of an other tion in the PANBIO West Nile Virus IgM Capture ELISA. The samples were treated with 0.005M Dithiothreitol (DTT) to remove IgM antibodies. The untreated and treated samples were then tested on the PANBIO West Nile Virus IgM Capture treator and trouted samples showed a significant decrease in absorbance. A further study consisting of 8 serum samples with known levels of IgM and IgG antibodies to WNV showed no effect on IgM reactivity when these samples were treated with a goat anti-human IgG absorbent. These studies indicate that the assay is specific for IgM antibodies and that specific WNV IgG antibodies do not interfere with the assay.

EFFECTS OF FREEZE-THAW CYCLES

A study consisting of 8 serum samples with varying levels of IgM antibodies to WNV was conducted to determine the effects of multiple freeze-thaw cycles on the detection of WNV IgM antibodies in patient sera. This study indicates that five freeze-thaw cycles have little effect on the detection of IgM antibodies, and therefore it is recommended that samples may undergo up to three freeze-thaw cycles for testing purposes.

4

REPRODUCIBILITY

The reproducibility of the PANBIO West Nile Virus IgM Capture ELISA was The reproduciblity of the PANDIS each on 3 different assays at one Australian delemined by testing of other of the USA. Within-run, between site and study site and two study sites in the obsir of Variance (ANOVA Type II). The results are presented in Table 5 below.

Precision Measures (Using Index Value)
Sample	n	*Mean	Within		Between Day		Between Site		Total
			*S.D	CV	*S.D	CV	*S.D	CV	*S.D	CV
Positive	27	2.63	0.18	7.0%	0.00	0.0%	0.28	10.6%	0.29	11.2%
Cut-off	27	1.00	0.03	2.8%	0.00	0.0%	0.00	0.0%	0.03	2.6%
Negative	27	0.23	0.03	13.7%	0.00	0.0%	0.03	12.3%	0.04	16.8%
#1	27	2.77	0.18	6.6%	0.06	2.3%	0.43	15.7%	0.41	14.7%
#2	27	2.63	0.09	3.5%	0.00	0.0%	0.31	11.9%	0.28	10.5%
#3	27	3.26	0.10	2.9%	0.00	0.0%	0.40	12.4%	0.35	10.7%
#4	27	1.23	0.04	2.8%	0.00	0.0%	0.12	9.4%	0.10	8.3%
#5	27	1.20	0.05	4.3%	0.01	0.6%	0.10	8.6%	0.10	8.3%
#6	27	1.44	0.06	4.1%	0.02	1.6%	0.15	10.1%	0.14	9.5%
#7	27	0.83	0.04	4.7%	0.01	1.0%	0.08	9.6%	0.08	9.3%
#8	27	1.04	0.06	5.3%	0.00	0.0%	0.09	8.7%	0.09	8.9%

Table 5 - Reproducibility Study (Three Sites) ision Measures (Using Index Value*)

All values are calculated from Index values (Cut-Off using O.D) SD = Standard Deviation; CV = Coefficient of Variation

Note: Standard Deviation results have been rounded to two decimal places for tabulation purposes. * Index value is calculated by dividing the sample absorbance by the cut-off value.

CROSS REACTIVITY

This study consisted of a panel of 160 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 IgM Capture ELISA through the analysis of specimens from patients 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 IgM Capture ELISA. Table 6 below provides a summary of specimens in the disease panel outlined in Table 7.

5

Disease State	Study Site	PANBIO IgG ELISA Results
		Pos	Eqv	Total Reactive
Epstein-Barr virus	1	0	0	0/15 0.0%
Varicella-Zoster virus	1	0	0	0/15 0.0%
Cytomegalovirus	1	0	0	0/15 0.0%
Ross River virus	1	0	0	0/26 0.0%
Enterovirus	1	0	0	0/7 0.0%
Dengue virus	1	2	0	2/16 12.5%
St. Louis encephalitis	1	0	0	0/6 0.0%
La Crosse encephalitis	1, 2a	0	0	0/19 0.0%
Hepatitis A	1	0	0	0/11 0.0%
Anti-Nuclear Antibody	1	0	0	0/15 0.0%
Rheumatoid Factor	1	3	1	4/15 26.7%
Total		5	1	6/160 3.8%

Table 6 – Summary of Cross-reactivity Study PANBIO West Nile Virus IgM Capture ELISA (E-WNV02M)

a Samples tested in-house at PANBIO except for 9/19 La Crosse encephalitis - Gamples toolou in nouos it il house it in Ohio, USA.

6

TABLE 7 Results of Cross-reactivity Study

| Sample | Site | IgM Antibody Type ELISA Result | |
|--------|------|------------------ | | | | 1 | 1 | La Crosse encephalitis | 2 | 1 | La Crosse encephalitis | 3 | 1 | La Crosse encephalitis | 4 | 1 | La Crosse encephalitis | 5 | 1 | La Crosse encephalitis | 6 | 1 | La Crosse encephalitis | 7 | 1 | La Crosse encephalitis | 8 | 1 | La Crosse encephalitis | 9 | 1 | La Crosse encephalitis | 10 | 1 | La Crosse encephalitis | 11 | 2 | La Crosse encephalitis | 12 | 2 | La Crosse encephalitis | 13 | 2 | La Crosse encephalitis | 14 | 2 | La Crosse encephalitis | 15 | 2 | La Crosse encephalitis | 16 | 2 | La Crosse encephalitis | 17 | 2 | La Crosse encephalitis | 18 | 2 | La Crosse encephalitis | 19 | 2 | La Crosse encephalitis | 20 | 1 | Saint Louis | 21 | 1 | Saint Louis | 22 | 1 | Saint Louis | 23 | 1 | Saint Louis | 24 | 1 | Saint Louis | 25 | 1 | Saint Louis | 26 | 1 | Rheumatoid Factor | 27 | 1 | Rheumatoid Factor | 28 | 1 | Rheumatoid Factor | 29 | 1 | Rheumatoid Factor | 30 | 1 | Rheumatoid Factor | 31 | 1 | Rheumatoid Factor | 32 | 1 | Rheumatoid Factor | 33 | 1 | Rheumatoid Factor | 34 | 1 | Rheumatoid Factor | 35 | 1 | Rheumatoid Factor | 36 | 1 | Rheumatoid Factor | 37 | 1 | Rheumatoid Factor | 38 | 1 | Rheumatoid Factor | 39 | 1 | Rheumatoid Factor | Sample | Site | IgM Antibody Type ELISA Result | |
| | | | 40 | 1 | Rheumatoid Factor | 41 | 1 | Anti-Nuclear Antibody | 42 | 1 | Anti-Nuclear Antibody | 43 | 1 | Anti-Nuclear Antibody | 44 | 1 | Anti-Nuclear Antibody | 45 | 1 | Anti-Nuclear Antibody | 46 | 1 | Anti-Nuclear Antibody | 47 | 1 | Anti-Nuclear Antibody | 48 | 1 | Anti-Nuclear Antibody | 49 | 1 | Anti-Nuclear Antibody | 50 | 1 | Anti-Nuclear Antibody | 51 | 1 | Anti-Nuclear Antibody | 52 | 1 | Anti-Nuclear Antibody | 53 | 1 | Anti-Nuclear Antibody | 54 | 1 | Anti-Nuclear Antibody | 55 | 1 | Anti-Nuclear Antibody | 56 | 1 | Hepatitis A | 57 | 1 | Hepatitis A | 58 | 1 | Hepatitis A | 59 | 1 | Hepatitis A | 60 | 1 | Hepatitis A | 61 | 1 | Hepatitis A | 62 | 1 | Hepatitis A | 63 | 1 | Hepatitis A | 64 | 1 | Hepatitis A | 65 | 1 | Hepatitis A | 66 | 1 | Hepatitis A | 67 | 1 | Epstein-Barr virus | 68 | 1 | Epstein-Barr virus | 69 | 1 | Epstein-Barr virus | 70 | 1 | Epstein-Barr virus | 71 | 1 | Epstein-Barr virus | 72 | 1 | Epstein-Barr virus | 73 | 1 | Epstein-Barr virus | 74 | 1 | Epstein-Barr virus | 75 | 1 | Epstein-Barr virus | 76 | 1 | Epstein-Barr virus | 77 | 1 | Epstein-Barr virus | 78 | 1 | Epstein-Barr virus | 79 | 1 | Epstein-Barr virus | 80 | 1 | Epstein-Barr virus | 81 | 1 | Epstein-Barr virus | Sample | Site | IgM Antibody Type ELISA Result | |
| | | | 82 | 1 | Dengue virus | 83 | 1 | Dengue virus | 84 | 1 | Dengue virus | 85 | 1 | Dengue virus | 86 | 1 | Dengue virus | 87 | 1 | Dengue virus | 88 | 1 | Dengue virus | 89 | 1 | Dengue virus | 90 | 1 | Dengue virus | 91 | 1 | Dengue virus | 92 | 1 | Dengue virus | 93 | 1 | Dengue virus | 94 | 1 | Dengue virus | 95 | 1 | Dengue virus | 96 | 1 | Dengue virus | 97 | 1 | Dengue virus | 98 | 1 | Cytomegalovirus | 99 | 1 | Cytomegalovirus | 100 | 1 | Cytomegalovirus | 101 | 1 | Cytomegalovirus | 102 | 1 | Cytomegalovirus | 103 | 1 | Cytomegalovirus | 104 | 1 | Cytomegalovirus | 105 | 1 | Cytomegalovirus | 106 | 1 | Cytomegalovirus | 107 | 1 | Cytomegalovirus | 108 | 1 | Cytomegalovirus | 109 | 1 | Cytomegalovirus | 110 | 1 | Cytomegalovirus | 111 | 1 | Cytomegalovirus | 112 | 1 | Cytomegalovirus | 113 | 1 | Varicella-Zoster virus | 114 | 1 | Varicella-Zoster virus | 115 | 1 | Varicella-Zoster virus | 116 | 1 | Varicella-Zoster virus | 117 | 1 | Varicella-Zoster virus | 118 | 1 | Varicella-Zoster virus | 119 | 1 | Varicella-Zoster virus | 120 | 1 | Varicella-Zoster virus | 121 | 1 | Varicella-Zoster virus | 122 | 1 | Varicella-Zoster virus | 123 | 1 | Varicella-Zoster virus | Sample | Site | IgM Antibody Type ELISA Result | |
| | | | 124 | 1 | Varicella-Zoster virus | 125 | 1 | Varicella-Zoster virus | 126 | 1 | Varicella-Zoster virus | 127 | 1 | Varicella-Zoster virus | 128 | 1 | Ross River virus | 129 | 1 | Ross River virus | 130 | 1 | Ross River virus | 131 | 1 | Ross River virus | 132 | 1 | Ross River virus | 133 | 1 | Ross River virus | 134 | 1 | Ross River virus | 135 | 1 | Ross River virus | 136 | 1 | Ross River virus | 137 | 1 | Ross River virus | 138 | 1 | Ross River virus | 139 | 1 | Ross River virus | 140 | 1 | Ross River virus | 141 | 1 | Ross River virus | 142 | 1 | Ross River virus | 143 | 1 | Ross River virus | 144 | 1 | Ross River virus | 145 | 1 | Ross River virus | 146 | 1 | Ross River virus | 147 | 1 | Ross River virus | 148 | 1 | Ross River virus | 149 | 1 | Ross River virus | 150 | 1 | Ross River virus | 151 | 1 | Ross River virus | 152 | 1 | Ross River virus | 153 | 1 | Ross River virus | 154 | 1 | Enterovirus | 155 | 1 | Enterovirus | 156 | 1 | Enterovirus | 157 | 1 | Enterovirus | 158 | 1 | Enterovirus | 159 | 1 | Enterovirus | 160 | 1 | Enterovirus | PANBIO E-WNV02M
--------|---------------------------------|--------|
| Index | Result |
| 0.47 | N |
| 0.28 | N |
| 0.34 | N |
| 0.26 | N |
| 0.31 | N |
| 0.30 | N |
| 0.58 | N |
| 0.38 | N |
| 0.31 | N |
| 0.37 | N |
| 0.39 | N |
| 0.34 | N |
| 0.38 | N |
| 0.32 | N |
| 0.45 | N |
| 0.25 | N |
| 0.24 | N |
| 0.30 | N |
| 0.25 | N |
encephalitis | 0.31 | N |
encephalitis | 0.23 | N |
encephalitis | 0.21 | N |
encephalitis | 0.27 | N |
encephalitis | 0.27 | N |
encephalitis | 0.23 | N |
| 0.18 | N |
| 4.84 | P |
| 1.86 | P |
| 3.76 | P |
| 0.25 | N |
| 0.33 | N |
| 0.98 | E |
| 0.41 | N |
| 0.34 | N |
| 0.61 | N |
| 0.36 | N |
| 0.24 | N |
| 0.54 | N |
| 0.44 | N |
| PANBIO E-WNV02M
| Index | Result |
| 0.42 | N |
| 0.23 | N |
| 0.20 | N |
| 0.22 | N |
| 0.27 | N |
| 0.18 | N |
| 0.25 | N |
| 0.24 | N |
| 0.20 | N |
| 0.24 | N |
| 0.25 | N |
| 0.28 | N |
| 0.26 | N |
| 0.41 | N |
| 0.27 | N |
| 0.18 | N |
| 0.33 | N |
| 0.35 | N |
| 0.23 | N |
| 0.22 | N |
| 0.21 | N |
| 0.44 | N |
| 0.38 | N |
| 0.31 | N |
| 0.26 | N |
| 0.69 | N |
| 0.46 | N |
| 0.17 | N |
| 0.26 | N |
| 0.22 | N |
| 0.21 | N |
| 0.26 | N |
| 0.42 | N |
| 0.25 | N |
| 0.20 | N |
| 0.26 | N |
| 0.25 | N |
| 0.27 | N |
| 0.25 | N |
| 0.33 | N |
| 0.33 | N |
| 0.34 | N |
| PANBIO E-WNV02M
| Index | Result |
| 0.59 | N |
| 0.32 | N |
| 0.30 | N |
| 0.36 | N |
| 0.51 | N |
| 0.40 | N |
| 0.33 | N |
| 1.26 | P |
| 1.27 | P |
| 0.37 | N |
| 0.32 | N |
| 0.27 | N |
| 0.30 | N |
| 0.56 | N |
| 0.41 | N |
| 0.48 | N |
| 0.43 | N |
| 0.24 | N |
| 0.27 | N |
| 0.53 | N |
| 0.31 | N |
| 0.51 | N |
| 0.39 | N |
| 0.41 | N |
| 0.34 | N |
| 0.54 | N |
| 0.33 | N |
| 0.22 | N |
| 0.27 | N |
| 0.37 | N |
| 0.52 | N |
| 0.34 | N |
| 0.55 | N |
| 0.23 | N |
| 0.31 | N |
| 0.30 | N |
| 0.23 | N |
| 0.28 | N |
| 0.69 | N |
| 0.24 | N |
| 0.24 | N |
| 0.21 | N |
| PANBIO E-WNV02M
| Index | Result |
| 0.27 | N |
| 0.31 | N |
| 0.20 | N |
| 0.40 | N |
| 0.26 | N |
| 0.28 | N |
| 0.23 | N |
| 0.30 | N |
| 0.24 | N |
| 0.26 | N |
| 0.20 | N |
| 0.17 | N |
| 0.27 | N |
| 0.25 | N |
| 0.60 | N |
| 0.28 | N |
| 0.23 | N |
| 0.19 | N |
| 0.21 | N |
| 0.23 | N |
| 0.39 | N |
| 0.17 | N |
| 0.18 | N |
| 0.21 | N |
| 0.24 | N |
| 0.21 | N |
| 0.27 | N |
| 0.19 | N |
| 0.22 | N |
| 0.15 | N |
| 0.42 | N |
| 0.34 | N |
| 0.27 | N |
| 0.28 | N |
| 0.19 | N |
| 0.27 | N |
| 0.29 | N |

7

8

・

9

INTERPRETATION

ELISA	Positive = P	Equivocal	Negative = N
PANBIO Index	> 1.1	0.9 - 1.1