(385 days)
This in vitro diagnostic method is intended to quantitatively measure Rubella IgG in human serum on the Technicon Immuno 1® System. Measurements of Rubella IgG are designed to aid in the determination of immune status by detecting IgG class antibodies to rubella virus in human sera. The method is not intended for use on any other system.
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The provided document describes the Immuno 1® Rubella IgG method and its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (Immuno 1 Rubella IgG method) |
|---|---|---|
| Accuracy (Relative to Comparator Assays) - Initial | Not explicitly stated as acceptance criteria, but evaluated against comparator assays. | Relative Sensitivity: - vs. Sanofi Platelia: 83.6% (Exp1), 83.0% (Exp2) - vs. Abbott IMx (Site 1): 85.7% (RCG), 86.5% (RDG) - vs. Abbott IMx (Site 2): 88.2% (RCG), 89.0% (RDG) Relative Specificity: - vs. Sanofi Platelia: 98.0% (Exp1), 98.6% (Exp2) - vs. Abbott IMx (Site 1): 100% (RCG & RDG) - vs. Abbott IMx (Site 2): 100% (RCG & RDG) |
| Accuracy (Relative to Comparator Assays) - HAI Resolved | Not explicitly stated as acceptance criteria, but evaluated against comparator assays with HAI resolution. | Relative Sensitivity: - vs. Sanofi Platelia: 96.6% (Exp1), 96.2% (Exp2) - vs. Abbott IMx (Site 1): 94.3% (RCG), 94.8% (RDG) - vs. Abbott IMx (Site 2): 98.2% (RCG & RDG) Relative Specificity: - vs. Sanofi Platelia: 99.5% (Exp1), 99.6% (Exp2) - vs. Abbott IMx (Site 1): 100% (RCG & RDG) - vs. Abbott IMx (Site 2): 100% (RCG & RDG) |
| Overall Agreement (OA) - Initial | Not explicitly stated as acceptance criteria. | OA: - vs. Sanofi Platelia: 86.5% (Exp1), 86.4% (Exp2) - vs. Abbott IMx (Site 1): 87.9% (RCG), 88.6% (RDG) - vs. Abbott IMx (Site 2): 90.0% (RCG), 90.7% (RDG) |
| Overall Agreement (OA) - HAI Resolved | Not explicitly stated as acceptance criteria. | OA: - vs. Sanofi Platelia: 97.5% (Exp1), 97.2% (Exp2) - vs. Abbott IMx (Site 1): 95.6% (RCG), 96.0% (RDG) - vs. Abbott IMx (Site 2): 98.6% (RCG & RDG) |
| ROC Area Under Curve (AUC) - Initial | Not explicitly stated as acceptance criteria, but reported. | AUC: - vs. Platelia (In-House): 0.976 - vs. IMx (Site 1): 0.988 - vs. IMx (Site 2): 0.989 |
| ROC Area Under Curve (AUC) - HAI Resolved | Not explicitly stated as acceptance criteria, but reported. | AUC: - vs. Platelia (In-House): 0.998 - vs. IMx (Site 1): 0.997 - vs. IMx (Site 2): 0.996 |
| Imprecision (CV) | Not explicitly stated as acceptance criterion, but results are summarized in Table 1. | Total CV: - 10 IU/mL: 7.1% - 20 IU/mL: 7.5% - 200 IU/mL: 6.7% |
| Reproducibility (Overall Agreement %) | Not explicitly stated as acceptance criterion, but results are presented. | Overall Agreement: - Miles In House: 99.5% (Exp1), 99.5% (Exp2) - NC Baptist Hospital: 99.0% (RCG), 98.7% (RDG) - Huntsville Hospital: 99.0% (RCG), 98.2% (RDG) |
| Interference | "No clinically significant effect on method performance" for specified substances. | - Hemolyzed: Up to 1000 mg/dL hemoglobin, no clinically significant effect. - Lipemic: Up to 900 mg/dL triglycerides, no clinically significant effect. - Icteric: Up to 25 mg/dL total bilirubin, no clinically significant effect. - Cross-reactivity: No false positives with rheumatoid factor, EBV, CMV, VZV, HSV-1, HSV-2, or rubeola relative to Sanofi Platelia. |
| CDC Proficiency Panel | Correct classification of CDC panel samples. | All CDC Rubella proficiency panel samples correctly classified. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sanofi Platelia comparison (In-House at Miles Inc.):
- Sample Size: 719 clinical samples.
- Data Provenance: 520 samples from "Michigan Department of Public Health" and the remaining purchased from "an outside vendor, Boston Biomedica," to increase negative samples. This suggests a retrospective collection, likely from a US population (Michigan).
- Abbott IMx comparison (Outside Clinical Sites):
- Site 1 (NC Baptist Hospital, Winston-Salem, NC):
- Sample Size: 296 samples.
- Data Provenance: From NC Baptist Hospital, Winston-Salem, NC (USA). Likely retrospective clinical samples.
- Site 2 (Huntsville Hospital, Huntsville, AL):
- Sample Size: 287 samples.
- Data Provenance: From Huntsville Hospital, Huntsville, AL (USA). Likely retrospective clinical samples.
- Site 1 (NC Baptist Hospital, Winston-Salem, NC):
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document refers to "All HAI testing was done by a state health agency reference laboratory" and "A report provided by Dr. John Stewart. VEH Branch of the CDC in Atlanta." This indicates that Haemagglutination Inhibition (HAI) testing, a recognized standard for Rubella immunity, was used for resolution. The expertise is implied by the "state health agency reference laboratory" and "CDC," both highly reputable organizations in infectious disease diagnostics, but the specific number or qualifications of individual experts are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The adjudication method described is discrepant analysis by HAI (Haemagglutination Inhibition).
For samples where the Immuno 1 method and the comparator assays (Sanofi Platelia or Abbott IMx) disagreed, HAI testing was used to resolve the discrepancy ("Discrepant samples were analyzed by HAI and the results used for resolution").
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study evaluates an automated in vitro diagnostic device (Immuno 1 Rubella IgG method), not an AI system assisting human readers. Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study primarily demonstrates standalone performance. The Immuno 1 Rubella IgG method is an automated quantitative assay for measuring Rubella IgG in human serum. Its performance is compared directly against other established assays (Sanofi Platelia, Abbott IMx) and against a ground truth resolved by HAI, without explicit human interpretation contributing to the Immuno 1 result itself. The device itself is the "algorithm only" (automated assay) in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth used for resolving discrepancies and establishing clinical performance was Haemagglutination Inhibition (HAI) testing. This is a well-established serological method for determining Rubella immune status, effectively serving as an "expert reference method" or a "gold standard assay" in this context.
Additionally, the "CDC Rubella proficiency panel" was used, for which the CDC establishes the ground truth classification.
8. The sample size for the training set
The document does not explicitly describe a separate "training set" in the context of machine learning or algorithm development. The data presented are for method validation and comparison studies. If the term "training set" is interpreted broadly as data used for developing and optimizing the assay itself prior to its final validation, that information is not provided in this summary. The "calibrators" (0, 10, 20, 50, 200, 500 IU/mL) are used for internal calibration, not typically considered a training set in the context of AI.
9. How the ground truth for the training set was established
As there is no explicit "training set" described in the context of an AI/algorithm, the method for establishing its ground truth is not applicable and not described in this document. The assay's analytical characteristics (e.g., calibrator values) are traceable to the WHO 2nd International Standard for Anti-Rubella Serum.
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APR 1 5 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
RUBELLA IgG METHOD FOR THE IMMUNO 1® SYSTEM
Listed below are comparisons of the performance between the Immuno 1 Rubella IgG method (T01-3547-51) and similar devices that were granted FDA determination of substantial equivalence: the Sanofi Platelia Rubella IgG kit and the Abbott IMx Rubella IgG assay. The comparative data with the Sanofi Platelia assay was collected in-house at Miles Inc. on two manufactured lots of reagents. The comparative data with the Abbott IMx assay was collected at two outside clinical sites using two additional lots of manufactured reagents. All HAI testing was done by a state health agency reference laboratory
The information used in this Summary of Safety and Effectiveness was extracted from the Rubella IgG method sheet and from data on file at Miles Inc. A report provided by the CDC for results obtained with the Immuno 1 Rubella IgG method for the CDC Rubella serum panel is attached as Appendix 1.
INTENDED USE
This in vitro diagnostic method is intended to quantitatively measure Rubella IgG in human serum on the Technicon Immuno 1® System. Measurements of Rubella IgG are designed to aid in the determination of immune status by detecting IgG class antibodies to rubella virus in human sera. The method is not intended for use on any other system.
CHARACTERISTICS
The assay has a range of 0 to 500 IU/mL Six calibrators are used with values of 0, 10, 20, 50, 200, 500 IU/mL, traceable to the WHO 2nd International Standard for Anti-Rubella Serum. Agreement between Immuno 1® Rubella IgG Calibrators and a set of calibrators prepared with the WHO Standard is shown in Figure 1 with regression analysis.
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IMMUNO 1 vs WHO Rubella IgG Calibrators
Image /page/1/Figure/1 description: This image is a scatter plot comparing WHO calibrators to IMMUNO 1 calibrators, both measured in IU/mL. The main plot shows a linear relationship between the two calibrators, with values ranging from 0 to 600 IU/mL. An inset plot provides a closer view of the relationship at lower concentrations, ranging from 0 to 30 IU/mL for both calibrators.
Image /page/1/Figure/2 description: Figure 1 shows the correlation between Immuno 1 Rubella IgG calibrators and the WHO International Standard. Ten replicate measurements were made at each calibrator level. The figure is labeled as Figure 1.
Linear regression analysis yielded the following results:
Y = 1.020 X + 2.984 R = 0.9989 95% CI intercept = 2.984 ± 3.781 95% CI slope = 1.020 ± 0.017
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Cut-off Value Selection
The cutoff value is 10 IU/mL. based on recommendations of the NCCLS and the CDC. Accordingly, the NCCLS subcommittee ".... recommends the use of 10 IU/mL as an indicator of immune status. This breakpoint detects most seropositive persons. Because detection of nonimmune status is clinically more important, selecting 10 IU/mL as the indicator of immune status favors immunization." The assay is calibrated against the WHO 2nd International Rubella IgG standard. The validity of using 10 IU/mL as the cut-off in the Immuno 1 Rubella IgG assay is demonstrated by the comparative clinical performance, Table 3, and summarized by the receiver-operator-curve analysis (ROC) shown in Figures 2a thru 2f and Table 4 of this report. A report provided by Dr. John Stewart. VEH Branch of the CDC in Atlanta, shows that the Immuno-1 Rubella IgG method correctly classified all of the CDC Rubella proficiency panel samples (Appendix 1).
IMPRECISION
Imprecision claims for the IMMUNO 1® Rubella IgG method are based on data collected at two independent clinical site studies. Results are summarized in Table 1. These estimates of imprecision were obtained from replicate assays of human serum pools, controls, and calibrators. Imprecision estimates were collected and computed according to NCCLS document EP5-T2, User Evaluation of Precision Performance of Clinical Chemistry Devices; Tentative Guideline. On-board reagent and calibration stability claims are 60 and 30 days, respectively. Calibration stability requires recovery of target values within ± 2 standard deviations of the claimed level specific total standard deviations.
| Table 1. Imprecision of Immuno 1 Rubella IgG Method | ||
|---|---|---|
| ----------------------------------------------------- | -- | -- |
| LEVEL(IU/mL) | SDTOTAL(IU/mL) | CVTOTAL(%) | SDWITHIN-RUN(IU/mL) | CVWITHIN-RUN(%) |
|---|---|---|---|---|
| 10 | 0.7 | 7.1 | 0.5 | 5.5 |
| 20 | 1.5 | 7.5 | 1.4 | 7.2 |
| 200 | 13.4 | 6.7 | 10.1 | 5.0 |
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METHOD COMPARISONS
Comparative results to the Abbott IMx were collected from two clinical sites. each using two lots of Immuno 1 Rubella IgG manufactured reagents. The Pasteur Diagnostics Platelia results were obtained in-house also, using two lots of manufactured reagents different from those used at the clinical sites. Thus a total of four manufactured reagent lots are represented in the method comparisons.
Sensitivity and Specificity
Sensitivity and specificity results, relative to the Sanofi Platelia and the Abbott IMx Rubella IgG assays, are presented in Table 2. The Platelia results were generated on 719 clinical samples (520 from Michigan Department of Public Health and the remaining purchased from an outside vendor, Boston Biomedica, in order to increase the number of negative samples). The sample IU/mL distributions for the in-house and two clinical sites analyses are given in Table 2. The additional negative samples were supplied to the clinical sites as masked specimens.
| IU/mL Range | IN-HOUSENo. Smpls | % Total | SITE 1No. Smpls | % Total | SITE 2No. Smpls | % Total |
|---|---|---|---|---|---|---|
| 0 to < 10 | 242 | 33.7 | 80 | 27.0 | 69 | 24.0 |
| 10 to < 20 | 100 | 13.9 | 25 | 8.4 | 41 | 14.3 |
| 20 to < 40 | 95 | 13.2 | 32 | 10.8 | 65 | 22.6 |
| 40 to < 60 | 55 | 7.6 | 25 | 8.4 | 36 | 12.5 |
| 60 to < 100 | 59 | 8.2 | 32 | 10.8 | 21 | 7.3 |
| 100 to < 300 | 135 | 18.8 | 83 | 28.0 | 48 | 16.7 |
| 300 to < 500 | 19 | 2.6 | 12 | 4.1 | 7 | 2.4 |
| ≥500 | 14 | 1.9 | 7 | 2.4 | 0 | 0 |
| Total | 719 | 100 | 296 | 100 | 287 | 100 |
Distribution of Serum Immuno 1 Rubella IgG values. Table 2.
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Immuno 1 Rubella IgG Relative Sensitivity and Relative Specificity in Table 3. comparison to Sanofi Platelia and Abbott IMx Rubella IgG assays. The Platelia data was collected in-house. IMx data was collected at two outside clinical laboratories. Results are calculated using 10 IU/mL as the cut-off point. The 95% confidence intervals for relative sensitivity and relative specificity were calculated as plus/minus 1.96 times the square root of p(1-p)/n where p is the sensitivity (or specificity) and n is the sample size. The lower 95% confidence interval limit for 100% values are approximated using 99%. Overall agreement (OA) is the percentage of correct results. Discrepant samples were analyzed by HAI and the results used for resolution.
Miles Inc., Elkhart, IN
| UNRESOLVED PLATELIA | HAI RESOLVED PLATELIA | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pos | Neg | Sen (%) | Spec (%) | OA (%) | Pos | Neg | Sen (%) | Spec (%) | OA (%) | ||
| Immuno 1 Pos | 478 | 3 | 83.6±3.0 | 98.0±2.3 | 86.5 | 480 | 1 | 96.6±1.6 | |||
| Lot Exp1 Neg | 94 | 144 | 17 | 221 | 99.5±0.9 | 97.5 | |||||
| Immuno 1 Pos | 475 | 2 | 83.0±3.1 | 98.6±1.9 | 86.4 | 476 | 1 | 96.2±1.7 | |||
| Lot Exp2 Neg | 97 | 145 | 19 | 223 | 99.6±0.8 | 97.2 |
:
Site 1: NC Baptist Hospital, Winston-Salem, NC
| UNRESOLVED IMx | HAI RESOLVED IMx | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Pos | Neg | Sen(%) | Spec(%) | OA(%) | Pos | Neg | Sen(%) | Spec(%) | OA(%) | |
| Immuno 1 Pos 216Lot RCG Neg 36 | 216 | 0 | $85.7\pm4.7$ | $100\pm2.2$ | 87.9 | 216 | 0 | $94.3\pm3.1$ | $100\pm2.2$ | 95.6 |
| Immuno 1 Pos 218Lot RDG Neg 34 | 218 | 0 | $86.5\pm4.5$ | $100\pm2.2$ | 88.6 | 218 | 0 | $94.8\pm3.1$ | $100\pm2.2$ | 96.0 |
Site 2: Huntsville Hospital, Huntsville, AL
| Pos | Neg | Sen(%) | Spec(%) | OA(%) | Pos | Neg | Sen(%) | Spec(%) | OA(%) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Immuno 1 Pos | 217 | 0 | 88.2±4.3 | 217 | 0 | 98.2±1.8 | ||||
| Lot RCG Neg | 29 | 45 | 100±2.3 | 90.0 | 4 | 70 | 100±2.3 | 98.6 | ||
| Immuno 1 Pos | 219 | 0 | 89.0±4.1 | 219 | 0 | 98.2±1.8 | ||||
| Lot RDG Neg | 27 | 45 | 100±2.3 | 90.7 | 4 | 68 | 100±2.3 | 98.6 |
. . . . . . . . . . .
5
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Receiver-Operating Characteristic (ROC) Analysis
The area under the ROC plot is used to estimate the diagnostic accuracy of the Immuno 1 Rubella IgG assay relative to Platelia and IMx Rubella IgG assays. ROC plots before and after HAI resolution, are shown in figure 2 a-f. The ROC plot areas are reported in Table 4. ROC plots were constructed and analyzed according to NCCLS Document GP10-T (1993) "Assessment of the Clinical Accuracy of the Laboratory Tests Using Receiver Operating Characteristics (ROC) Plots: Tentative Guideline".
- Figure 2. ROC Plots. (a.b) In-House with Immuno 1 and the Platelia Rubella IgG assays. (c.d) Site 1 data for Immuno 1 and the IMx Rubella IgG assays, and (e,f) Site 2 data for Immuno 1 and the IMx Rubella IgG assays .
Image /page/5/Figure/3 description: The image shows a plot titled "IMMUNO-1 and Pistella Rubella IgG Unresolved". 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 0.9766. The curve starts at the bottom left corner and rises sharply before gradually flattening out near the top right corner.
(a) Unresolved In-house Immuno 1 and Platelia Results (Area = 0.9766)
Image /page/5/Figure/5 description: This image is a plot titled "ROC Plot: IMMUNO-1 and HAI Resolved Plateile Results". 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 labeled as AREA = 0.9990.
(b) HAI Resolved In-house Immuno 1 and Platelia Results (Area = 0.9980)
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Image /page/6/Figure/0 description: This image is a plot titled "ROC Plot: IMMUNO-1 and IMx Unresolved Results: NC BAPTIST HOSP". The plot shows the true positive fraction on the y-axis and the false positive fraction on the x-axis. The area under the curve is 0.988.
(c). Unresolved Immuno 1 versus IMx, NC Baptist Hospital Area = 0.988
Image /page/6/Figure/2 description: This image is a plot titled "ROC Plet: IMMUNO-1 versus IMx HAI Resolved Results: NC BAPTIST HOSP". 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 0.997, which indicates a high level of accuracy. The curve is close to the top left corner of the plot, indicating that the test has a high sensitivity and specificity.
(d) Resolved Immuno 1 versus IMx, NC Baptist Hospital Area = 0.997
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Image /page/7/Figure/0 description: This image is a ROC plot comparing IMMUNO-1 versus Inix. 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 0.980, indicating a high level of diagnostic accuracy. The data is from Unresolved Results at Huntsville Hospital.
(e) Unresolved Immuno 1 versus IMx, Huntsville Hospital, Area = 0.989
Image /page/7/Figure/2 description: This image is a ROC plot of IMMUNO-1 versus IMx. 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 0.998, which indicates a high level of accuracy. The data was resolved by HAI at Huntsville Hospital.
(f) Resolved Immuno 1 versus IMx, Huntsville Hospital Area = 0.996
Table 4. ROC Plot Areas
| SITE | ComparativeMethod | UnresolvedROC Area | HAI ResolvedROC Area |
|---|---|---|---|
| Miles Inc. | Platelia | 0.976 | 0.998 |
| NC Baptist Hosp | IMx | 0.988 | 0.997 |
| Huntsville Hosp | IMx | 0.989 | 0.996 |
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Reproducibility
The classification agreement or reproducibility between duplicate results for the various reagent lots tested is presented in Table 5. The titer distribution of the sample population used in the replicate analysis for rubella IgG Exp 1 and Exp 2 reagent lots was selected in order to meet the NCCLS guidelines for reproducibility of replicate testing and is shown in Table 6. The titer distribution for the clinical site sample populations is given in Table 1.
| Miles In House | Replicate 2 | Overall Agreement (%) | |||
|---|---|---|---|---|---|
| Pos | Neg | ||||
| Exp 1 Lot Replicate 1 | Pos | 158 | 1 | ||
| Neg | 0 | 41 | 99.5 | ||
| Exp 2 Lot Replicate 1 | Pos | 158 | 0 | ||
| Neg | 1 | 41 | 99.5 | ||
| NC Baptist Hospital | |||||
| RCG Lot | Replicate 1 | Pos | 214 | 2 | |
| Neg | 1 | 79 | 99.0 | ||
| RDG Lot | Replicate 1 | Pos | 217 | 1 | |
| Neg | 3 | 75 | 98.7 | ||
| Huntsville Hospital | |||||
| RCG Lot | Replicate 1 | Pos | 215 | 2 | |
| Neg | 1 | 68 | 99.0 | ||
| RDG Lot | Replicate 1 | Pos | 214 | 3 | |
| Neg | 2 | 65 | 98.2 |
Table 5. Reproducibility of replicate results.
- Table 6. Titre distribution of the in-house sample set used to measure reproducibility for Exp 1 & 2 Rubella IgG Reagent Lots in Table 5 above.
| IU/mL Range | Number of Samples | % Total |
|---|---|---|
| < 10 | 41 | 20.5 |
| 10 to < 20 | 63 | 31.5 |
| 20 to < 40 | 20 | 10.0 |
| 40 to < 60 | 11 | 5.5 |
| 60 to < 100 | 49 | 24.5 |
| ≥ 100 | 16 | 8.0 |
| Total | 200 | 100 |
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RESULTS
Samples with results <10 IU/mL are considered negative for the presence of rubella IgG antibodies. Samples with results greater than or equal to 10 IU/mL are considered positive for the presence of IgG antibody to rubella.
The results reported by the laboratory to the physician should include the following statement: "The following results were obtained with the Technicon Immuno 1® Rubella IgG antibody test. IgG values obtained with different manufacturer assay methods may not be used interchangeably. The magnitude of the reported IgG level cannot be correlated to an endpoint titer."
INTERFERENCES
The use of hemolyzed (up to 1000 mg/dL of hemoglobin), lipemic (up to 900 mg/dL of triglycerides) or icteric (up to 25 mg/dL of total bilrubin) samples have no clinically significant effect on method performance, Table 7. Patient samples containing rheumatoid factor, antibodies to Epstein-Barr virus, cytomegalovirus, varicella zoster virus, Herpes Type I virus, Herpes Type II virus and rubeola (measles) virus produced no false positive results in comparison to the Sanofi Platelia method.
TABLE 7 INTERFERING SUBSTANCES
CHOLESTEROL
TRIGLYCERIDE
| mg/dL | IU/mLRUB IgG | % CV | %BIAS | mg/dL | IU/mLRUB IgG | % CV | %BIAS |
|---|---|---|---|---|---|---|---|
| 500 | 10.9810.99 | 1.541.29 | -0.09 | 2250 | 10.5912.74 | 3.382.75 | -16.88 |
| 1000 | 10.1010.09 | 6.343.17 | 0.10 | 4500 | 12.0312.61 | 2.550.46 | -4.60 |
| 3000 | 7.827.66 | 1.312.75 | 2.09 | 6750 | 11.2312.18 | 1.721.61 | -7.80 |
| 4000 | 6.886.90 | 2.942.84 | -0.29 | 9000 | 11.2012.36 | 1.250.64 | -9.39 |
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HEMOGLOBIN
BILIRUBIN
. . .
| mg/dL | IU/mLRUB IgG | % CV | %BIAS | mg/dL | IU/mLRUB IgG | % CV | %BIAS |
|---|---|---|---|---|---|---|---|
| 2500 | 11.9612.16 | 1.721.34 | -1.64 | 6.250 | 12.8212.24 | 1.291.50 | 4.74 |
| 5000 | 11.0110.66 | 1.601.26 | 3.28 | 12.50 | 12.4612.48 | 2.813.49 | -0.16 |
| 7500 | 10.3510.09 | 2.561.79 | 2.58 | 18.750 | 12.1311.72 | 2.471.45 | 3.50 |
| 10000 | 8.858.12 | 2.395.21 | 8.99 | 250 | 11.2811.29 | 1.411.13 | -0.09 |
이유 : 100 : 100 : 100 :
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.