(385 days)
Centocor CA 125 II™ RIA
K/DEN number: Not Found
No
The device description details a standard immunoassay with a cubic-through-zero curve fitting algorithm, which is a traditional statistical method, not AI/ML. There are no mentions of AI, ML, or related concepts in the document.
No
This device is an in vitro diagnostic assay used to measure a biomarker in serum to aid in the detection of residual ovarian carcinoma. It does not directly treat or prevent a disease.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures."
No
The device description clearly outlines a physical immunoassay kit involving reagents, magnetic particles, and a system for measurement, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Bayer Immuno 1™ CA 125 Il Assay is an in vitro device for the quantitative measurement of OC 125 reactive determinants associated with a high molecular glycoprotein in serum of women with primary epithelial invasive ovarian cancer."
This statement clearly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bayer Immuno 1™ CA 125 II™ Assay, hereafter referred to as Immuno 1 CA 125 II™ Assay, is an in vitro device indicated for the quantitative measurement of OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer. The CA 125 II Assay is indicated as a one time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. An assay value of greater than 35 U/mL is indicative of residual disease, provided that alternative causes of an elevated CA 125 II assay value can be excluded (see under Limitations of the Procedure). It is recommended that the assessment and treatment of patients with ovarian cancer and the use of the Bayer Immuno 1 CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecological cancers.
Product codes (comma separated list FDA assigned to the subject device)
LTK
Device Description
The Bayer Immuno 1™ CA 125 II™ Assay is a sandwich immunoassay in which one monoclonal antibody (M11) is conjugated to fluorescein (R1) and a second monoclonal antibody (OC 125) is conjugated to alkaline phosphatase (R2), An Immuno 1 Magnetic Particle coated with anti-fluorescein antibody, the R1 conjugate, and patient sample, calibrator, or control are mixed simultaneously and incubated at 37°C on the system. The R2 conjugate is then added, and binds to the immobilized CA 125 II to form a sandwich immunocomplex on the solid phase. The magnetic particles complexed with the immunological sandwich are then washed to separate unbound molecules, and a colorimetric substrate is added. The rate of conversion of substrate to a compound with absorbance at 405 and 450 mm is measured; the measured rate is proportional to the concentration of CA 125 II antigen in the sample. A cubic-through-zero curve fitting algorithm is used to generate standard curves. The assay uses six calibrators with CA 125 II concentrations of 0, 15, 30, 80, 200, and 500 U/mL.
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
physician trained and experienced in the management of gynecological cancers
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
The clinical evaluation of the Bayer Immuno 174 CA 125 IJ14 Assay as a one time test for use an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures, was performed by comparison of the Immuno 1 CA 125 II™ Assay values with second look diagnostic outcome and with the FDA-approved Centocor CA 125 II™ RIA results in a sampling of the target population. In addition, this concordance study evaluated the relationship between Immuno 1 CA 125 II™ Assay and the Centocor CA 125 III™ RIA values using a panel of 703 serum samples from healthy subjects and patients with benign diseases, ovarian cancer, and other malignant diseases.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical studies were performed to evaluate assay sensitivity (minimum detectable concentration), assay specificity (interfering substances), imprecision, linearity, parallelism, hook effect, and lot-to-lot variation.
MINIMUM DETECTABLE CONCENTRATION: An MDC of 0.24 U/mL was observed, based on multiple determinations of the Level 1 calibrator (0 U/mL), on four systems, using two lots of reagents.
IMPRECISION: Within-run and total assay imprecision were evaluated by testing five levels of Immuno 1 CA 125 IT™ assay calibrators, BioRad Turnor Marker Controls, and an internal medical decision level serum pool (approximately 28 U/mL) over a period of twenty days of assay qualification runs. Imprecision was evaluated at three clinical trial sites. Within-run imprecision ranged from 1.4% to 3.6% CV, and total imprecision ranged from 2.2% to 3.9% CV across products and sites.
LINEARITY: Four clinical sample pools containing a high concentration of CA 125 II assay values (450-500 UlmL) were diluted with normal serum (low CA 125 II assay values) to final concentrations of 100% (undiluted) 75%, 50%, 25%, and 0% (low CA 125 II serum only). Each pool was assayed with two lots of Immuno 1 CA 125 II reagent. Recoveries of the intermediate dilutions were all between 98% and 106% of the expected value.
HOOK EFFECT: CA 125 antigen was prepared in Level 1 calibrator at concentrations of 70, 50, 25, 10, 2, 0.5, and 0.25 kUmL. This collection of samples was tested in triplicate using two lots of reagent. The assay response measured as the observed reaction rate, did not "hook" back into the assay range, even at the highest concentration of antigen tested (70 kU/mL).
LOT-TO-LOT VARIATION: 309 samples were included in this analysis. This sample collection included specimens from healthy subjects and patients with malignant and non-malignant diseases. Immuno 1 CA 125 IITM Assay results obtained with Trial 1 and Trial 2 reagents showed excellent concordance. The linear least squares regression equation for the lot-to-lot analysis was: Trial 2 = 1.011 x Trial 1 - 0.092; r = 1.000; Syx = 2.47
PARALLELISM: Four individual serum samples from cancer patients were each diluted with normal serum to a CA 125 II concentration of approximately 500 U/mL. Each sample was then diluted with Level 1 CA 125 II calibrator (0 U/mL CA 125) to a final concentration of 100% (undiluted), 75%, 50%, 25%, 10%, and 0%. All dilutions were analyzed using two lots of reagent. Sample recoveries ranged from 99.6% to 11.4%. Linear regression analysis for each clinical sample showed no deviation from linearity.
METHOD CONCORDANCE: 703 female serum samples were used in a correlation study. The 703 serum samples consisted of 197 normal samples (pre- and post-menopausal), 253 single point ovarian cancer specimens, 50 lung cancer specimens, 52 breast cancer specimens, 50 colorectal cancer specimens, 48 samples from patients with a variety of other cancers (pancreatic, renal, liver, uterine, cervical , endometrial), 50 benign urogenital disease samples, and 3 unknown disease samples with elevated CA 125 II values. The correlation between the Immuno 1 CA 125 II™ Assay and the Centocor CA 125 II™ RIA for all samples was: Slope = 0.823, Intercept = 20.318, N = 703, R = 0.985. For samples within the linear range of both assays (n=668), the correlation was: Slope = 0.975, Intercept = 2.778, N = 668, R = 0.983.
CLINICAL STUDY: 48 patients were evaluated; 29 patients were diagnosed with residual disease following second look surgery. The Immuno 1 CA 125 II™ Assay showed a sensitivity of 31%, specificity of 95%, positive predictive value of 90%, and negative predictive value of 47%. Equivalent results were obtained for the Centocor assay (Sensitivity: 21%, Specificity: 89%, Positive Predictive Value: 75%, Negative Predictive Value: 43%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Immuno 1 CA 125 II™ Assay: Sensitivity: 31%, Specificity: 95%, Positive Predictive Value: 90%, Negative Predictive Value: 47%
Centocor CA 125 II™ Assay: Sensitivity: 21%, Specificity: 89%, Positive Predictive Value: 75%, Negative Predictive Value: 43%
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.
Centocor CA 125 II™ RIA
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
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
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KA640098
OCT 31 1997
SUMMARY OF SAFETY AND EFFECTIVENESS For the Bayer Immuno 1TM CA 125 II™ Assay
This premarket notification is to add the quantitative measurement of CA 125 IITM assay values in human serum to the intended use of the Bayer Immuno 1™Immunoassay System. The performance characteristics of the Bayer Immuno 1™ CA 125 II™ Assay, substantial equivalence of this assay to the predicate device, the Centocor CA 125 II™ RIA, and evidence of safety and effectiveness in the target population has been established in accordance with Section VI. of the "Guidance Document For Submission of Tumor Associated Antigen Premarket Notifications, 510(k), to the FDA." The information presented in this Summary of Safety and Effectiveness was derived from nonclinical performance and clinical evaluation studies comparing the Immuno 1 CA 125™ Assay to the Centocor CA 125 IITM RIA.
INDICATIONS FOR USE
The Bayer Immuno 1 ™ CA 125 II™ Assay, hereafter referred to as Immuno 1 CA 125 II™ Assay, is an in vitro device indicated for the quantitative measurement of OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer. The CA 125 II Assay is indicated as a one time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. An assay value of greater than 35 U/mL is indicative of residual disease, provided that alternative causes of an elevated CA 125 II assay value can be excluded (see under Limitations of the Procedure). It is recommended that the assessment and treatment of patients with ovarian cancer and the use of the Bayer Immuno 1 CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecological cancers.
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BACKGROUND
General. CA 125 is an antigenic determinant on a high-molecular-weight glycoprotein historically recognized by the monoclonal antibody OC 125, which was raised using an ovarian cancer cell line as an immunogen. The CA 125 determinant is expressed by epithelial ovarian turnors as well as by other tissues. The function of the glycoprotein expressing CA 125 is unknown, and, because of its complex nature, information about the physical and immunological nature of this antigen is limited.
Serum levels of CA 125 were initially reported to be elevated in > 80% of patients with ovarian cancer and to reflect the clinical course of the disease. Subsequently, a great deal of research and clinical interest has concentrated on the role of this antigen in several aspects of the management of ovarian malignancy including detection of residual carcinoma following completion of first line therapy.
In addition to ovarian cancer, serum levels of CA 125 are elevated in a number of other pathological and physiological states. Of particular interest in the area of human reproduction is the evidence from studies of tissue distribution that the CA 125 determinant is a normal product of endometrial tissue. Serum CA 125 levels are elevated in some individuals at the time of menstruation, in early pregnancy and in endometriosis. Recent studies suggest that serum CA 125 measurement may be also be of value in the management of endometriosis.
The Nature of the CA 125 Determinant. Column chromatography and SDS-PAGE electrophoresis followed by Western blotting indicate that CA 125 activity in ovarian cancer serum, amniotic fluid, human milk and supernatant from an ovarian cancer cell line is associated with a moiety of > 1.000,000 daltons and a lower-molecular-weight morety of 200,000 - 400,000 daltons. Although the precise nature of the CA 125 determinant remains unclear, there is agreement that the molecule with which it is associated is a glycoprotein. Using antigen purified from an ovarian cancer cell line, a
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carbohydrate content of 24% was reported on the basis of carbohydrate compositional analysis and buoyant density. This is a lower carbohydrate content than is typical for mucins, such as the other epithelial tumor antigens recognized by monoclonal antibodies (e.g., 19-9, B72.3, DU-PAN-2 and F36/22). Differences were noted in the buoyant density of the CA 125 antigen isolated from human milk, seminal plasma and an overian cancer cell line suggesting slight variability in protein or carbohydrate content.
CA 125 Serum Levels in Healthy Controls and Benign Disease. Expression of CA 125 is neither specific for ovarian cancer, nor for cancerous tissue in general. The CA 125 antigen has been demonstrated in cyst fluids of benign and malignant turnors, in benign and malignant pleural effusions, in ascites of benign and malignant origin, in human milk, in seminal plasma, in amniotic fluid and in cervical mucus. C.A. 125 is probably a secretory product of many normal human epithelia and shedding of the antigen occurs from the cell surface, possibly by an active shedding mechanism.
The cutoff level of the CA 125 assay was originally set at 35 U/mL which was the 99th percentile of a large population of blood donors. Many additional studies over the years have shown that, on average, 2.5 % of healthy subjects have CA 125 levels greater than 35 U/mL. A recent study has revealed that the CA 125 assay is not markedly influenced by sex, age or smoking status. However, remarkably high levels of CA 125, exceeding 65 UlmL, can be found in the first trimester of pregnancy and during menstruation. At the onset of menstruation, a sudden increase from normal values to levels exceeding 300 U/mL has been observed, possibly due to an easy access of CA 125 from the endometrial epithelial lining into the circulation during menstruation. Another explanation may be that retrograde menstruation might cause seeding of endometrial cells throughout the abdominal cavity, resulting in local inflammatory reactions and CA 125 elevation. Various authors have measured CA 125 levels in patients with benign diseases. The reported percentage of CA 125 elevations exceeding 35 UlmL ranged between 2% and 42% and those exceeding 65 U/mL ranged between 1% and 16%, depending on the population studied. Several benign diseases were found to be associated with CA 125
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elevation, some of which may cause differential diagnostic problems. Patients with effusions caused by benign diseases such as congestive heart failure, tuberculosis or liver cirrhosis can be highly positive, as can patients with benign gynecological diseases such as uterine myofibroma and benign ovarian tumors. Patients with endometriosis, or especially with endometriotic cysts, may have highly elevated CA 125 levels.
CA 125 Serum Levels in Non-Ovarian Malignancies. A CA 125 serum test can be positive in a wide variety of non-ovarian malignant conditions. Other gynecological carcinomas, especially those of the endometrium, fallopian tube and cervix can be positive in a substantial percentage of cases. Likewise, cancers of non-gynecological origin, such as colon and pancreas, can give rise to increased serum levels of CA 125. Also, tumors originating in organs other than the ovaries give rise to CA 125 elevations once metastasized to the ovaries. Therefore, the role of the CA 125 test in differential diagnostics between various malignancies seems to be of limited value.
CA 125 Serum Levels in Ovarian Cancer. Pretreatment levels reflect the amount of circulating turnor-associated antigen in relation to the extent of disease at the time of staging. In Stage 1 disease, 43% of all patients reported had elevated CA 125 serum levels. Consequently, in more than half of all patients with malignant disease limited to one or both ovaries (with or without malignant cells in ascites fluid or washing), CA 125 serum values were within the normal range.
Whether or not the differential grade of ovarian carcinoma correlates with CA 125 levels is not clear. Several reports have suggested that CA 125 levels increase with decreasing degree of differentiation, although this correlation was not always statistically significant or even necessarily apparent.
CA 125 elevations have been reported to precede the clinical detection of turnor progression or tumor recurrence. The lead times observed ranged between several weeks to seventeen months. After a complete clinical or pathological remission, a significant
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rise in CA 125 levels preceded turnor recurrence in more than 85% of all patients. In the other patients, CA 125 remained below the cutoff level, or remained stable, or rose only after clinical detection of tumor recurrence.
In the absence of clinical signs of tumor presence, ovarian cancer patients may undergo a "second look" procedure in order to verify surgically if all turnor deposits have disappeared. In a large number of studies, patients with CA 125 levels above 35 U/mL, who appeared clinically free of turnor, were shown to have turnor at second look in 95% of cases. A more recent study of advanced ovarian cancer patients found residual disease at second-look surgery in 92% of patients with CA 125 values between 20 and 35 U/mL. However, in all studies, only half of all patients with marker levels within the normal range were surgically free of turnor, either macroscopically or microscopically. The other half still had turnor present despite normal CA 125 levels (although many reports indicated that in these cases turnor lesions did not exceed one cm in the largest diameter). Thus, the CA 125 test can be of help in the management of ovarian cancer patients. In particular, at the time of second look, surgical procedures might be deferred in patients with CA 125 levels which remain in the normal range.
DEVICE DESCRIPTION
Indicated Use. The Bayer Immuno 17M CA 125 IIM Assay is an in vitro device indicated for the quantitative measurement of OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive overian cancer. The CA 125 II Assay is indicated as a one time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. An assay value of greater than 35 U/mL is indicative of residual disease, provided that alternative causes of an elevated CA 125 II assay value can be excluded (see under Limitations of the Procedure). It is recommended that the assessment and treatment of patients with ovarian cancer and the
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use of the Bayer Immuno 1 CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecological cancers.
Description of the Assay. The Bayer Immuno ITM CA 125 II™ Assay is a sandwich immunoassay in which one monoclonal antibody (M11) is conjugated to fluorescein (R1) and a second monoclonal antibody (OC 125) is conjugated to alkaline phosphatase (R2), An Immuno 1 Magnetic Particle coated with anti-fluorescein antibody, the R1 conjugate, and patient sample, calibrator, or control are mixed simultaneously and incubated at 37°C on the system. The R2 conjugate is then added, and binds to the immobilized CA 125 II to form a sandwich immunocomplex on the solid phase. The magnetic particles complexed with the immunological sandwich are then washed to separate unbound molecules, and a colorimetric substrate is added. The rate of conversion of substrate to a compound with absorbance at 405 and 450 mm is measured; the measured rate is proportional to the concentration of CA 125 II antigen in the sample. A cubic-throughzero curve fitting algorithm is used to generate standard curves. The assay uses six calibrators with CA 125 II concentrations of 0, 15, 30, 80, 200, and 500 U/mL.
A schematic representation of the Magnetic Separation Sandwich Immunoassay of the Bayer Immuno 11m System is presented in Figure 1. A typical standard curve for the Immuno 1 CA 125 IITM Assay is presented in Figure 2.
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Schematic Representation of the Magnetic Separation Sandwich Immunoassay of the Bayer Figure 1. Immuno 1" System
Image /page/6/Figure/1 description: The image shows a graph of AU/min vs U/ml. The x-axis represents U/ml, and the y-axis represents AU/min. The graph shows a linear relationship between AU/min and U/ml. The data points are (0, 0.0093), (15, 0.0445), (30, 0.0795), (80, 0.1980), (200, 0.4786), and (500, 1.1398).
Figure 2. Standard Curve for the Bayer Immuno 1 ™ CA 125 II™ Assay.
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POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH
The Immuno 1 CA 125 II™ Assay is intended for in virro diagnostic use only. There are no known potential adverse effects on the health of clinically managed patients when this device is used as indicated. It is imperative that the physician use the Immuno 1 CA 125 II™ test results in conjunction with the patient's overall clinical assessment and other diagnostic tests. False test results could affect physician decisions regarding treatment. If falsely low, treatment may be delayed in cases of recurring or progressing ovarian cancer. If falsely high, new therapy or a change in treatment may be instituted unnecessarily. These false positive and false negative values should not lead to patient mismanagement as it is recommended that CA 125 II™ assay values be used in conjunction with the results of the patient's overall clinical assessment and under the order of a physician trained and experienced in the management of gynecological cancers.
PRECAUTIONS AND WARNINGS
This device is not indicated for ovarian cancer screening, or as a sole diagnostic tool to confirm the presence or absence of malignant ovarian disease. CA 12.5 II™ assay values should be used for the management of ovarian cancer patients in conjunction with the information from a complete clinical evaluation including physical exam and other diagnostic tests. CA 125 assay values greater than or equal to 35 U/mL may be found in 1-2% of healthy individuals and in patients with non-malignant conditions, such as pericarditis, cirrhosis, severe hepatic necrosis, endometriosis, first trimester pregnancy, ovarian cysts, or in patients with non-ovarian malignancies, such as uterine, hepatic, pancreatic, and lung cancers. A CA 125 [[™ assay value below 35 U/mL does not insure the absence of residual ovarian cancer because patients with histological evidence of ovarian carcinoma have demonstrated CA 125 II™ assay values within the range for healthy individuals. Therefore, serum CA 125 II™ assay levels should not be interpreted as absolute evidence of the presence or absence of malignant disease.
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The concentration of CA 125 antigenic determinants in a given specimen determined with assays from different manufacturers can vary due to differences in assay methodology and reagent specificity. The results reported by the laboratory to the physician must include the identity of the CA 125 assay used. Values obtained with different CA 125 assays cannot be used interchangeably.
SUMMARY OF STUDIES
Nonclinical studies were performed to evaluate assay sensitivity (minimum detectable concentration), assay specificity (interfering substances), imprecision, linearity, parallelism, hook effect, and lot-to-lot variation.
The clinical evaluation of the Bayer Immuno 174 CA 125 IJ14 Assay as a one time test for use an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures, was performed by comparison of the Immuno 1 CA 125 II™ Assay values with second look diagnostic outcome and with the FDA-approved Centocor CA 125 II™ RIA results in a sampling of the target population. In addition, this concordance study evaluated the relationship between Immuno 1 CA 125 II™ Assay and the Centocor CA 125 III™ RIA values using a panel of 703 serum samples from healthy subjects and patients with benign diseases, ovarian cancer, and other malignant diseases.
NONCLINICAL STUDIES
Characterization of the Antigen. The antigen used in the Immuno 1 CA 125 III-1 assay calibrators is the OC 125 reactive determinant (designated OC 125 antigen) isolated from the culture supernatant fluid of McDonald Anchorage Dependent Cells (OVCA 433). The antigen is produced by Centocor and is supplied to Bayer in a partially purified form.
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Immunoreactivity of the Antibodies. Monoclonal antibody preparations M11 and OC 125 are used in the Immuno 1 CA 125 II™ Assay. Both antibodies are manufactured by Centocor, Inc., and are supplied to Bayer in partially purified form.
Specificity And Interfering Substances. The recovery of CA 125 II™ assay values, was studied before and after spiking with potentially interfering endogenous and exogenous substances. The potential interferents were spiked into patient samples with elevated levels of CA 125 or into the Medical Decision Pool, an internal serum-based control containing a CA 125 concentration of approximately 28 U/mL
Common Endogenous Interferents. The Immuno 1 CA 125 II™ Assay was performed on ovarian cancer patient specimens with elevated values of CA 125 or in the Medical Decision Pool to which was added various concentrations of either triglycerides, immunoglobulin, hemoglobin, glycoprotein, bilirubin, or albumin. The highest concentration of each potential endogenous interferent and the maximum effect on the observed CA 125 recovery are summarized in Table 1.
| Interferent | Highest
Concentration
Tested | % Recovery in
Patient sera
50 U/mL CA 125 | % Recovery in
Medical Decision Pool
28 U/mL CA 125 |
|----------------|------------------------------------|-------------------------------------------------|----------------------------------------------------------|
| Triglycerides | 900 mg/dL | Not Tested | 102.8 |
| Immunoglobulin | 5.3 g/dL | 99.9 | 100.6 |
| Hemoglobin | 1.0 g/dL | 103.8 | 101.5 |
| Glycoprotein | 1 mg/mL | Not Tested | 101.1 |
| Bilirubin | 25 mg/dL | Not Tested | 97.3 |
| Albumin | 6.5 g/dL | 107.0 | 106.8 |
Table 1. Interference
The greatest effect (6.8%-7.0%), demonstrated by Albumin, was observed in all serum media including the high patient sample and the Medical Decision Pool. Albumin was spiked at a concentration above the NCCLS recommended test level of 6 g/dL. This effect
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of 35 U/mL | 9 | 1 | 10 |
| 35 U/mL | 6 | 2 | 8 |
|