Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic assay for detecting antibodies and does not mention any AI/ML components or related concepts like image processing, training sets for algorithms, or specific AI/ML performance metrics.

Therapeutic

No.
This device is an in vitro diagnostic method used to measure Toxoplasma IgG in human serum. It aids in the determination of serological status by detecting IgG class antibodies to Toxoplasma gondii. It is not intended for treating or preventing a disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic method is intended to quantitatively and qualitatively measure Toxoplasma IgG in human serum... The method is intended for in vitro diagnostic use only." This indicates its purpose is to diagnose the presence of Toxoplasma IgG from a sample.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic method intended for use on the Technicon Immuno 10 System, which is a hardware system. The description focuses on the performance of the assay and reagents, not on software functionality.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic method in intended to quantitatively and qualitatively measure Toxoplasma IgG in human serum..." and "The method is intended for in vitro diagnostic use only on the Technicon IMMUNO 1® system."

This language clearly indicates that the device is designed to be used outside of the body to examine specimens (human serum) for the purpose of providing information about a person's health (detecting antibodies to Toxoplasma gondii). This aligns with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

# Intended Use / Indications for Use
This in vitro diagnostic method in intended to quantitatively and qualitatively measure Toxoplasma IgG in human serum on the Technicon Immuno 10 System. Measurements of Toxoplasma IgG are designed to aid in the determination of serological status by detecting IgG class antibodies to Toxoplasma gondii in human sera. The Technicon Immuno 1 Toxoplasma IgG method is not intended for use in screening blood or plasma donors. The method is intended for in vitro diagnostic use only on the Technicon IMMUNO 1® system.

# Product codes (comma separated list FDA assigned to the subject device)
Not Found

# Device Description
The Technicon IMMUNO 1® Toxoplasma IgG is calibrated with six calibrators having values of 0. 10, 20, 50, 100, 300 IU/mL and traceable to the WHO anti-Toxoplasma Serum International Standard (TOXS-60) described in Attachment 5. Agreement between Toxoplasma IgG SETpoint Calibrators and the WHO TOXS-60 Standard is shown in Figure 1.

# 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
Not Found

# 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
Not Found

# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparisons:
Comparative results to the Abbott IMx were collected from two clinical trial sites each using two lots of Immuno 1 Toxoplasma IgG reagents. Resolution of discrepant results was done by IFA analysis using exclusion. Samples with Immuno 1 values

Regulation Number and Section

§ 866.3780

Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).

Summary

0

K955760

Enclosure 2

AUG - 2 1996

SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE TECHNICON TOXOPLASMA IgG METHOD FOR THE IMMUNO 1® SYSTEM

Listed below are comparisons of the performance between the IMMUNO 1® Toxoplasma IgG method (Attachment 1) and a similar device that was granted FDA determination of substantial equivalence: the Abbott IMx Toxoplasma IgG assay (Attachment 2). The comparative data with the Abbott IMx assay was collected at two outside clinical trial sites: University of Texas Medical Branch, Laboratory Medical Clinical Chemistry, Galveston, Texas and San Francisco General Hospital Clinical Laboratories, San Francisco, California. Two lots of IMMUNO 1® Toxoplasma IgG reagents were evaluated at each clinical site. IFA discrepant sample testing was done by BBI - North American Clinical Laboratories in New Britain, CT using Gull Laboratories Toxo IgG Indirect Fluorescent Antibody Test (Attachment 3). Discrepant samples for IFA testing were shipped directly to BBI from the clinical site.

INTENDED USE

This in vitro diagnostic method in intended to quantitatively and qualitatively measure Toxoplasma IgG in human serum on the Technicon Immuno 10 System. Measurements of Toxoplasma IgG are designed to aid in the determination of serological status by detecting IgG class antibodies to Toxoplasma gondii in human sera. The Technicon Immuno 1 Toxoplasma IgG method is not intended for use in screening blood or plasma donors. The method is intended for in vitro diagnostic use only on the Technicon IMMUNO 1® system.

CHARACTERISTICS

The Technicon IMMUNO 1® Toxoplasma IgG is calibrated with six calibrators having values of 0. 10, 20, 50, 100, 300 IU/mL and traceable to the WHO anti-Toxoplasma Serum International Standard (TOXS-60) described in Attachment 5. Agreement between Toxoplasma IgG SETpoint Calibrators and the WHO TOXS-60 Standard is shown in Figure 1.

1

Image /page/1/Figure/0 description: The image is a graph that plots "WHO 2nd International Standard (IU/mL)" on the y-axis and "SETpoint Toxoplasma IgG Cals (IU/mL)" on the x-axis. The x-axis and y-axis range from 0 to 300. A linear trendline is plotted on the graph, and the equation of the line is "Y = 0.905 X + 1.618" with an R-value of 0.9998.

Figure 1. Correlation between WHO Second International Toxoplasma Standard Preparation and Immuno 1 Toxoplasma IgG method calibrated with the Technicon SETpoint Toxoplasma IgG Calibrators.

Linear regression analysis yielded the following results:

$$\begin{array}{rcl} \mathsf{Y} = \mathsf{0.905} ,\mathsf{X} + \mathsf{1.618} \ \mathsf{R}^2 = \mathsf{0.9998} \ \mathsf{95%} ,\mathsf{CL} ,\mathsf{intercept} = \pm ,\mathsf{2.44} \ \mathsf{95%} ,\mathsf{CL} ,\mathsf{slope} = \pm ,\mathsf{0.019} \end{array}$$

METHOD COMPARISONS

Comparative results to the Abbott IMx were collected from two clinical trial sites each using two lots of Immuno 1 Toxoplasma IgG reagents. The clinical trial protocol and report are available in attachments contained in the 510(k). Resolution of discrepant results was done by IFA analysis using exclusion.

Samples with Immuno 1 values 300 | 3 | 1.3 | 6 | 2.7 |
| TOTAL | 223 | 100 | 225 | 100 |

TABLE 1: DISTRIBUTION OF SERUM TECHNICON IMMUNO 1 TOXOPLASMA IgG VALUES IN PRENATAL AND HOSPITAL SPECIMENS

In addition to the site supplied specimens, each site augmented their study with an additional 75 supplemental serum specimens unique to each site. The supplemental specimens were masked having both negative and positive samples and were supplied frozen. The additional samples were necessary in order to raise the number of positive specimens analyzed at each site. Of the 298 sera analyzed at clinical site 1, 110 had been frozen prior to analysis. Similarly, 117 out of the 300 sera analyzed at clinical site 2 had been frozen prior to analysis. The unfrozen specimens were fresh or had been stored at 2°C to 8℃ for less than 1 week after collection.

3

Sensitivity, Specificity and Overall Agreement

Sensitivity and specificity results are presented in Table 2 relative to the Abbott IMx Toxoplasma IgG method. Single replicate results for both the Immuno 1 and Abbott IMx assay were collected for comparison at the clinical sites. Discrepant samples at clinical site 2 were subsequently tested twice on both instruments and classified as either positive or negative based on two out of three results. Additional masked samples from Boston Biomedica Inc. were supplied to both clinical trial sites (see Clinical Trial Protocol and Report for additional information) in order to increase the number of Toxoplasma IgG positives.

Table 2. Immuno 1 Toxoplasma IgG Sensitivity and Specificity relative to the Abbott IMx Toxoplasma IgG assay. Site 1 is the University of Texas Medical Branch in Galvelston and Site 2 is San Francisco General Hospital. The cut-off for the Immuno 1 and IMx Toxoplasma IgG assays is 12 IU/mL and 6 IU/mL, respectively. Resolution by IFA excludes a discrepant result if agreement between IFA and Immuno 1 is found. The 95% confidence limits for sensitivity. specificity and overall agreement are calculated using exact binomial percentiles according to Blyth, C.R. , Approximate Binomial Confidence Limits, J Amer. Stat. Assoc, 81:843-855 (1986).

4

Site 1 University of Texas Medical Branch

| Immuno 1 Rgts &
Sample Description | Number of
Results by
IMx
Classification | No. of
Immuno 1
Results In
Agreement
with IMx
Classification | Sensitivity,
Specificity or
Overall
Agreement
(%) | 95% Confidence
Limits
(%) |
|---------------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------|
| Immuno 1 Lot 1 Rgts | | | | |
| Site 1 Supplied | | | | |
| Sensitivity | 49 | 45 | 91.8 | 80.4 - 97.7 |
| Specificity | 174 | 170 | 97.7 | 94.2 - 99.4 |
| Overall Agreement | 223 | 215 | 96.4 | 93.1 - 98.4 |
| Supplemental Samples | | | | |
| Sensitivity | 55 | 54 | 98.2 | 90.3 - 100 |
| Specificity | 20 | 18 | 90.0 | 68.3 - 98.8 |
| Overall Agreement | 75 | 72 | 96.0 | 88.8 - 99.2 |
| Combined | | | | |
| Sensitivity | 104 | 99 | 95.2 | 89.1 - 98.4 |
| Specificity | 194 | 188 | 96.9 | 93.4 - 98.9 |
| Overall Agreement | 298 | 287 | 96.3 | 93.5 - 98.1 |
| Immuno 1 Lot 2 Rgts | | | | |
| Site 1 Supplied | | | | |
| Sensitivity | 49 | 46 | 93.9 | 83.1 - 98.7 |
| Specificity | 174 | 169 | 97.1 | 93.4 - 99.1 |
| Overall Agreement | 223 | 215 | 96.4 | 93.1 - 98.4 |
| Supplemental Samples | | | | |
| Sensitivity | 55 | 53 | 96.4 | 87.5 - 99.6 |
| Specificity | 20 | 18 | 90.0 | 68.3 - 98.8 |
| Overall Agreement | 75 | 71 | 94.7 | 86.9 - 98.5 |
| Combined | | | | |
| Sensitivity | 104 | 99 | 95.2 | 89.1 - 98.4 |
| Specificity | 194 | 187 | 96.4 | 92.7 - 98.5 |
| Overall Agreement | 298 | 286 | 96.0 | 93.1 - 97.9 |

5

| Site 1 University of Texas Medical Branch - IFA Resolved | | | | | Immuno 1 Rgts &
Sample Description | Number of
Results by
IMx
Classification | No. of
Immuno 1
Results in
Agreement
with IMx
Classification | Sensitivity,
Specificity or
Overall
Agreement
(%) | 95% Confidence
Limits
(%) |
|----------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------|
| Immuno 1 Rgts &
Sample Description | Number of
Resolved
Results | No. of
Immuno 1
Results in
Agreement
with Resolved
Results | Sensitivity,
Specificity or
Overall
Agreement
(%) | 95% Confidence
Limits
(%) | Immuno 1 Lot 1 Rgts | | | | |
| Immuno 1 Lot 1 Rgts | | | | | Site 2 Supplied
Sensitivity
Specificity
Overall Agreement | 43
182
225 | 35
170
205 | 81.4
93.4
91.1 | 66.6 - 91.6
88.8 - 96.5
86.6 - 94.5 |
| Site 1 Supplied
Sensitivity
Specificity
Overall Agreement | 49
172
221 | 45
170
215 | 91.8
98.8
97.3 | 80.4 - 97.7
95.9 - 99.9
94.2 - 99.0 | Supplemental Samples
Sensitivity
Specificity
Overall Agreement | 48
27
75 | 48
26
74 | 100
96.3
98.7 | 92.6 - 100
81.0 - 99.9
92.8 - 100 |
| Supplemental Samples
Sensitivity
Specificity
Overall Agreement | 54
19
73 | 54
18
72 | 100
94.7
98.6 | 93.4 - 100
74.0 - 99.9
92.6 - 100 | Combined
Sensitivity
Specificity
Overall Agreement | 91
209
300 | 83
196
279 | 91.2
93.8
93.0 | 83.4 - 96.1
89.6 - 96.6
89.5 - 95.6 |
| Combined
Sensitivity
Specificity
Overall Agreement | 103
191
294 | 99
188
287 | 96.1
98.4
97.6 | 90.4 - 98.9
95.5 - 99.7
95.2 - 99.0 | Immuno 1 Lot 2 Rgts | | | | |
| Immuno 1 Lot 2 Rgts | | | | | Site 2 Supplied
Sensitivity
Specificity
Overall Agreement | 44
181
225 | 33
170
203 | 75.0
93.9
90.2 | 59.7 - 86.8
89.4 - 96.9
85.6 - 93.8 |
| Site 1 Supplied
Sensitivity
Specificity
Overall Agreement | 49
172
221 | 46
169
215 | 93.9
98.3
97.3 | 83.1 - 98.7
95.0 - 99.6
94.2 - 99.0 | Supplemental Samples
Sensitivity
Specificity
Overall Agreement | 48
27
75 | 47
26
73 | 97.9
96.3
97.3 | 88.9 - 99.9
81.0 - 99.9
90.7 - 99.7 |
| Supplemental Samples
Sensitivity
Specificity
Overall Agreement | 54
19
73 | 53
18
71 | 98.2
94.7
97.3 | 90.1 - 100
74.0 - 99.9
90.5 - 99.7 | Combined
Sensitivity
Specificity
Overall Agreement | 92
208
300 | 80
196
276 | 87.0
94.2
92.0 | 78.3 - 93.1
90.1 - 97.0
88.3 - 94.8 |
| Combined
Sensitivity
Specificity
Overall Agreement | 103
191
294 | 99
187
286 | 96.1
97.9
97.3 | 90.4 - 98.9
94.7 - 99.4
94.7 - 98.8 | | | | | |

s Medical Branch - IFA Resolved

6

Site 2 San Francisco General Hospital

7

| Immuno 1 Rgts &
Sample Description | Number of
Resolved
Results | No. of
Immuno 1
Results in
Agreement
with Resolved
Results | Sensitivity,
Specificity or
Overall
Agreement
(%) | 95% Confidence
Limits
(%) |
|----------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------|
| Immuno 1 Lot 1 Rgts | | | | |
| Site 2 Supplied
Sensitivity
Specificity
Overall Agreement | 43
182
225 | 35
170
205 | 81.4
93.4
91.1 | 66.6 - 91.6
88.8 - 96.5
86.6 - 94.5 |
| Supplemental Samples
Sensitivity
Specificity
Overall Agreement | 48
27
75 | 48
26
74 | 100
96.3
98.7 | 92.6 - 100
81.0 - 99.9
92.8 - 100 |
| Combined
Sensitivity
Specificity
Overall Agreement | 85
206
291 | 83
196
279 | 97.6
95.1
95.9 | 91.8 - 99.7
91.3 - 97.6
92.9 - 97.9 |
| Immuno 1 Lot 2 Rgts | | | | |
| Site 2 Supplied
Sensitivity
Specificity
Overall Agreement | 44
181
225 | 33
170
203 | 75.0
93.9
90.2 | 59.7 - 86.8
89.4 - 96.9
85.6 - 93.8 |
| Supplemental Samples
Sensitivity
Specificity
Overall Agreement | 48
27
75 | 47
26
74 | 97.9
96.3
98.7 | 88.9 - 99.9
81.0 - 99.9
92.8 - 100 |
| Combined
Sensitivity
Specificity
Overall Agreement | 85
206
291 | 80
196
276 | 94.1
95.1
94.8 | 86.8 - 98.1
91.3 - 97.6
91.6 - 97.1 |

Site 2 San Francisco General Hospital - IFA Resolved

:

8

| Immuno 1 Rgts &
Sample Description | Number of
Results by
IMx
Classification | No. of
Immuno 1
Results in
Agreement
with IMx
Classification | Sensitivity,
Specificity or
Overall
Agreement
(%) | 95% Confidence
Limits
(%) |
|---------------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------|
| Immuno 1 Lot 1 Rgts
All Specimens | | | | |
| Sensitivity | 195 | 182 | 93.3 | 88.9 - 96.4 |
| Specificity | 403 | 384 | 95.3 | 92.7 - 97.1 |
| Overall Agreement | 598 | 566 | 94.6 | 92.5 - 96.3 |
| Immuno 1 Lot 2 Rgts
All Specimens | | | | |
| Sensitivity | 196 | 179 | 91.3 | 86.5 - 94.9 |
| Specificity | 402 | 383 | 95.3 | 92.7 - 97.1 |
| Overall Agreement | 598 | 562 | 94.0 | 91.8 - 95.7 |

Combined Clinical Site 1 & 2 Results: Unresolved Results

Combined Clinical Site 1 & 2 Results: IFA Resolved

| Immuno 1 Rgts &
Sample Description | Number of
Resolved
Results | No. of
Immuno 1
Results in
Agreement
with Resolved
Results | Sensitivity,
Specificity or
Overall
Agreement
(%) | 95% Confidence
Limits
(%) |
|---------------------------------------|----------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------|
| Immuno 1 Lot 1 Rgts
All Specimens | | | | |
| Sensitivity | 188 | 182 | 96.8 | 93.2 - 98.8 |
| Specificity | 397 | 384 | 96.7 | 94.5 - 98.2 |
| Overall Agreement | 585 | 566 | 96.8 | 95.0 - 98.0 |
| Immuno 1 Lot 2 Rgts
All Specimens | | | | |
| Sensitivity | 188 | 179 | 95.2 | 91.1 - 97.8 |
| Specificity | 397 | 383 | 96.5 | 94.2 - 98.1 |
| Overall Agreement | 585 | 562 | 96.1 | 94.2 - 97.5 |

:

9

| STUDY
LOCATION | COMPARATIVE
METHOD | IMMUNO 1
DISCREPANCIES | DISCREPANT
RESULTS | IFA
POSITIVE | IFA
NEGATIVE |
|-------------------------------|-----------------------|----------------------------------|-----------------------|-----------------|-----------------|
| Clinical Site 1
Lot 1 Rgts | Abbott IMx | False Negative
False Positive | 5
6 | 4
3 | 1
3 |
| Lot 2 Rgts | Abbott IMx | False Negative
False Positive | 5
7 | 4
3 | 1
4 |
| Clinical Site 2
Lot 1 Rgts | Abbott IMx | False Negative
False Positive | 8
13 | 2
3 | 6
10 |
| Lot 2 Rgts | Abbott IMx | False Negative
False Positive | 12
12 | 5
2 | 7
10 |

Table 3: IFA RESULTS ON DISCREPANT SAMPLES

Receiver-Operating Characteristic (ROC) Analysis

The area under the ROC plots is used as an estimate of the diagnostic accuracy of the Immuno 1 Toxoplasma IgG assay relative to the IMx Toxoplasma IgG assay. ROC plots are shown in Figure 2 a-d for both TXG and TYG Immuno 1 Toxoplasma IgG reagent lots at Univ of Texas Medical Branch and San Francisco General Hospital.

10

Figure 2. ROC Plot analysis of comparative Immuno 1 and IMx Toxoplasma IgG methods.

Image /page/10/Figure/1 description: The image is a graph that plots the true positive fraction (sensitivity) on the y-axis and the false positive fraction (1 - specificity) on the x-axis. The graph shows a curve that rises sharply and then plateaus near the top. The area under the curve (AUC) is labeled as 0.990, and there is an arrow pointing to a point on the curve labeled "12 IU/mL".

(a) ROC Plot. Immuno 1 vs IMx. University of Texas Medical Branch employing TXG Lot 1 Immuno 1 Toxoplasma IgG Reagents. (Area = 0.990)

Image /page/10/Figure/3 description: This image is a graph that plots the true positive fraction (sensitivity) against the false positive fraction (1-specificity). The graph shows a curve that rises sharply and then plateaus near the top. The area under the curve is labeled as 0.989. There is also a label that says 12 IU/mL.

(b) ROC Plot. Immuno 1 vs IMx. University of Texas Medical Branch employing Lot 2 Immuno 1 Toxoplasma IgG Reagents. (Area = 0.989)

11

Image /page/11/Figure/0 description: The image is a ROC plot titled "IMMUNO1 ve IMx TOXOPLASMA IgG Rgt Lot 1 SAN FRANCISCO GEN HOSPITAL". The x-axis is labeled "FALSE POS FRACTION (1 - specificity)" and ranges from 0.0 to 1.0. The y-axis is labeled "TRUE POS FRACTION (sensitivity)" and ranges from 0.0 to 1.0. The area under the curve is 0.967, and there is an arrow pointing to a point on the curve labeled "12 IU/mL".

(c). ROC Plot. Immuno 1 vs IMx. San Francisco General Hospital employing Lot 1 Immuno 1 Toxoplasma IgG Reagents. (Area = 0.967)

Image /page/11/Figure/2 description: The image is a ROC plot comparing IMMUNO1 vs IMx TOXOPLASMA IgG. The plot shows the true positive fraction (sensitivity) on the y-axis and the false positive fraction (1 - specificity) on the x-axis. The area under the curve (AUC) is 0.968, and there is an arrow pointing to a point on the curve labeled "12 IU/mL".

(d) ROC Plot. Immuno 1 vs IMx. San Francisco General Hospital employing Lot 2 Immuno 1 Toxoplasma IgG Reagents. (Area = 0.968)

12

ROC Plot Areas for Immuno1 relative to the IMx Table 4. Toxoplasma IgG Method

| CLINICAL SITE | Immuno 1
Reagent Lot | Comparative
Method | ROC Area |
|-------------------------|-------------------------|-----------------------|----------|
| Univ of Texas MB | Lot 1 | IMx | 0.990 |
| Univ of Texas MB | Lot 2 | IMx | 0.989 |
| San Francisco GH | Lot 1 | IMx | 0.967 |
| San Francisco GH | Lot 2 | IMx | 0.968 |
| Combined Clinical Sites | Lot 1 | IMx | 0.980 |
| Combined Clinical Sites | Lot 2 | IMx | 0.980 |

Comparison of Immuno 1 Toxoplasma IgG Reagent Lots

The clinical results obtained with both Lots of Immuno 1 Toxoplasma IgG Reagents evaluated at the University of Texas MB and San Francisco General Hospital were compared both with respect to classification and correlation of clinical values.

Table 5. Reproducibility of results between Immuno 1 Toxoplasma IgG Reagent Lots at Univ. of Texas and San Francisco General Hospital

CLINICAL TRIAL SITE	LOT 2 REAGENTS
Univ. of Texas MB
LOT 1 REAGENTS	Pos Neg Pos 104 1 Neg 2 191	99.0
San Francisco GH
LOT 1 REAGENTS	Pos Neg Pos 91 4 Neg 0 205	98.7

Regression analysis of the results between reagent lots is given in Table 6. Correlation plots are presented in Figure 3 a&b.

13

Table 6. Regression analysis of Immuno 1 results between reagent lots. Results above 300 IU/mL omitted.

| Site | Immuno 1
Rubella IgG
Reagent Lot | Y (intercept)
± 95% C.L. | Slope
± 95% C.L. | R value |
|-------------------|----------------------------------------|-----------------------------|---------------------|---------|
| Univ. of Texas MB | Lot 1 vs Lot 2 | 0.59 ± 2.08 | 0.973 ± 0.029 | 0.969 |
| San Francisco GH | Lot 1 vs Lot 2 | 2.70 ± 2.20 | 0.993 ± 0.034 | 0.960 |

Figure 3. Correlation plots between Immuno 1 Toxoplasma IgG reagent lots 1 & 2. Results > 300 IU/mL are not shown.

Image /page/13/Figure/3 description: This image is a scatter plot comparing Reagent Lot 1 (TXG) and Reagent Lot 2 (TYG), both measured in IU/mL. The x-axis represents Reagent Lot 1, and the y-axis represents Reagent Lot 2, with values ranging from 0 to 300 IU/mL on both axes. The plot shows a positive correlation between the two reagent lots, with data points clustered around a diagonal line. This suggests a strong agreement between the measurements obtained using the two different reagent lots.

(8) Immuno 1 IgG reagent Lot 1 versus Lot 2. Data was collected at the University of Texas Medical Branch at Galvelston.

14

Image /page/14/Figure/0 description: The image is a scatter plot comparing Reagent Lot 1 (TXQ) IU/mL on the x-axis and Reagent Lot 2 (TYQ) IU/mL on the y-axis. The plot shows a positive correlation between the two reagent lots, with data points scattered around a straight line. The x and y axes range from 0 to 300, and the data points are clustered along the diagonal, indicating a strong agreement between the two reagent lots. The plot suggests that the two reagent lots are comparable in terms of their activity or concentration.

Toxoplasma IgG reagent Lot 1 versus Lot 2. Data was collected at the San
Francisco General Hospital. (b)

..:

15

Comparison of Immuno1 Toxoplasma IgG to IFA

The histogram in Figure 4 show the comparison between IFA and Immuno 1 Toxoplasma IgG results on 35 human sera 22 of which are negative. An IFA titre less than 16 is considered negative. IFA testing was performed by Boston Biomedica using Gull Laboratories IFA method. As expected the magnitude of the reported IgG level cannot be correlated to an endpoint titer.