(58 days)
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Not Found
No
The device description details a standard immunoassay procedure and data analysis using a "Cubic Fit Through Zero" for the dose response curve, which is a conventional statistical method, not AI/ML. There are no mentions of AI, ML, or related concepts in the summary.
No.
This device is an in vitro diagnostic (IVD) procedure intended for the quantitative determination of Myoglobin to aid in the early phase diagnosis of Myocardial Infarctions. It does not provide treatment or modify a bodily function, which are characteristics of a therapeutic device.
Yes
This device is described as an "in vitro diagnostic procedure" intended for the quantitative determination of Myoglobin, which "aides in the early phase diagnosis of Myocardial Infarctions." This explicitly states its purpose in diagnosis.
No
The device description clearly outlines a solid phase immunoassay involving physical reagents (monoclonal and polyclonal antibodies, magnetic particles, enzyme substrate) and a specific instrument (Technicon Immuno 1 system) for spectrophotometric measurement. This is a hardware-dependent in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic procedure is a solid phase immunoassay intended for the quantitative determination of Myoglobin in human serum or heparin plasma..."
This statement clearly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This in vitro diagnostic procedure is a solid phase immunoassay intended for the quantitative determination of Myoglobin in human serum or heparin plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of Myoglobin aides in the early phase diagnosis of Myocardial Infarctions.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The method described is an enzyme label sandwich assay using a monoclonal (mouse) capture and a polyclonal (goat) detector antibody. The monoclonal antibody is labelled with fluorescein and the polyclonal antibody labelled with alkaline phosphatase (ALP). The two reagents are the active compounds of the R1 and the R2 reagent, respectively. The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein (mIMP reagent). Sample or calibrator, R1and R2 reagent and mIMP reagent are mixed simultaneously and incubated at 37 °C. In the presence of Myoglobin fluorescein-conjugate= Myoglobin=ALPa conjugate complex is formed and captured by the antiFluorescein antibodies on the magnetic particles. The particles are precipitated by an external magnetic field, washed and para-Nitrophenylphosphate is added as the enzyme substrate. The increase in absorbance due to the formation of p-Nitrophenolate is monitored spectrophotometrically at 405 and 450 nm. The concentration of Myoglobin in a sample. A Cubic Fit Through Zero is used to calculate the dose response curve. The assay is depicted schematically in fig. 1.
The assay has a range of 0 to 3000 ng/mL with a sensitivity of 1.8 ng/mL; six calibrators with Myoglobin concentrations of 0, 60, 180, 600, 1500 and 3000 ng/mL are provided.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Assay Performance - Imprecision
Total imprecision data was obtained by analyzing human serum controls on two Immuno 1 instruments on 20 different days. Two separate lots of reagents and calibrators were used. Both reagent and calibrator combinations on both instruments were tested with two different lots of magnetic particles. The total number of replicates for each level was 160. The calibration was only performed when a new reagent/ calibrator lot or particle lot combination was implemented on a machine.
Key results are found in Table 1 on page 2, showing average concentration, standard deviation, and CV for total and within-run imprecision across 9 samples.
Correlation with Immuno 1 Myoglobin results with Behring Nephelometer A
A total of 100 serum and plasma samples with Behring Nephelometer (BNA) values in the range of 21 to 2660 ng/mL (BNA) were tested with the Behring Nephelometer A and the Immuno 1 Myoglobin assay. The correlation equation according to Bablock-Passing was y = 1.02 × x + 1.05 (y is Immuno 1 Myoglobin assay; x is Behring Nephelometer A Myoglobin assay).
Number of Samples: 100, Slope (b): 1.02, Intercept (a): 1.05, Confidence of Correlation: 0.99314.
Interference
- For all interference measurements a +2 Pool and a -2 Pool was prepared. The +2 Pool was made from a solution of Myoglobin in serum with a concentration of approximately 180 µg/l (double of the concentration at the medical decision point) being diluted 1+1 with a solution of the potentially interfering substance in Myoglobin-stripped serum at a concentration twice as high as required. This yields a Myoglobin concentration at the medical decision level with the required interferantconcentration. The -2 Pool was made up from the same Myoglobin solution, but this time being diluted 1+1 with stripped serum containing no interferant. So two solutions of exactly identical Myoglobin concentration were obtained, one containing no interferent, the other with the required high concentration. The 0-Pool was obtained mixing equivalent amounts of the +2- and the -2-Pool while the -1- and +1-Pool were prepared from equal quantities of the 0-Pool and the -2- respectively the +2-Pool.
- Substances tested for interference include Bilirubin, Albumin, Hemoglobin, Gamma Globulins, Triglycerides, Heparin, Citrate, Urea and Creatine, and Rheumatory Factor.
- Key results are presented in tables for each substance showing "Pool", "conc. (meas.)", and "% of -2 pool". The percentages generally range from 93.8% to 104.5%.
Linearity
All control to check linearity pools were generated in a way, that a serum sample with a high Myoglobin level (+2 Pool) and a low sample (-2 Pool) were mixed in a ratio of 1 + 1. The 0 Pool thus generated was furtherly mixed with the same amount of the +2 respectively the -2 Pool to have the +1 and -1 Pool. By that procedure five equally spaced controls covering the whole assay range are generated. For data analysis a linear regression was calculated from the result of the -2, -1 and 0 Pools of each sample series. The expected results and the deviation from the measured values were calculated from the equation.
Key results are shown in tables on page 9, including "Pool (Sample)", "measured", "calculated", and "dev (%)". Deviations are generally small, mostly within ±6.5%.
Sample Dilution
Dilution series with Immuno 1 Sample Diluent B and Immuno 1 Myoglobin Calibrator Level 1 were run for clinical serum and plasma samples. The recovery of the undiluted sample was set to 100%.
Key results are presented in tables on pages 10-12, showing "sample content %", "Identification", "AU/min", "conc.(meas.)", "conc.(calc)", and "recovery (%)" or "dev (%)". Recoveries are generally close to 100%.
Hook Effect
Samples with Myoglobin concentrations up to 1 Million ng/mL were assayed. The assay will not erroneously compute raw data to concentrations within the calibration range of the assay as long as the Myoglobin content in the sample is less than 150,000 ng/mL.
Recovery
Known amounts of Myoglobin Solution were spiked into four clinical samples, two serum samples, two plasma samples.
For serum the recoveries were ranging from 96.5 to 105.2 %; for plasma the recoveries are between 97.7 and 103%.
Key results are shown in tables on page 14, including "Sample", "Expected", "found", and "recovery".
Expected Values
Samples from 77 non AMI individuals were assayed. It was found that 98% of the values were 88 ng/mL or less.
Minimum Detectable Concentration
The minimum detectable concentration was measured in 32 different runs on four different days using two different lots of reagents, calibrators and magnetic particles. The L1 calibrator containing no Myoglobin was measured 576 times all together. Calculated from the mean zero absorption plus two standard deviations the minimum detectable dose was determined as 1.8 ng/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 1.8 ng/mL (Minimum Detectable Concentration)
Confidence of Correlation (with predicate): 0.99314
Recovery: 96.5 to 105.2% for serum; 97.7 to 103% for plasma.
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.
The Behring N Latex Myoglobin Reagents.
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.
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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
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).
0
AUG 1 5 1996
Summary of Safety and Effectiveness
MYOGLOBIN METHOD FOR THE IMMUNO 1 SYSTEM
Listed below is a comparison of the performance between the Immuno 1 Myoglobin method (T01-3653-51) and a similar device that was granted FDA determination of substantial equivalence: The Behring N Latex Myoglobin Reagents. This reagents are designed to run on the Behring Nephelometer. The information used in this summary of Safety and Effectiveness was extracted from the Myoglobin Method Sheet and from data on file at Bayer Corporation.
Intended Use
This in vitro diagnostic procedure is a solid phase immunoassay intended for the quantitative determination of Myoglobin in human serum or heparin plasma on the Technicon Immuno 1 system. When used in combination with other clinical data such as presenting symptoms and EKG values, measurement of Myoglobin aides in the early phase diagnosis of Myocardial Infarctions.
Assay Description
The method described is an enzyme label sandwich assay using a monoclonal (mouse) capture and a polyclonal (goat) detector antibody. The monoclonal antibody is labelled with fluorescein and the polyclonal antibody labelled with alkaline phosphatase (ALP). The two reagents are the active compounds of the R1 and the R2 reagent, respectively. The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein (mIMP reagent). Sample or calibrator, R1and R2 reagent and mIMP reagent are mixed simultaneously and incubated at 37 °C. In the presence of Myoglobin fluorescein-conjugate= Myoglobin=ALPa conjugate complex is formed and captured by the antiFluorescein antibodies on the magnetic particles. The particles are precipitated by an external magnetic field, washed and para-Nitrophenylphosphate is added as the enzyme substrate. The increase in absorbance due to the formation of p-Nitrophenolate is monitored spectrophotometrically at 405 and 450 nm. The
Image /page/0/Figure/10 description: The image shows a schematic representation of a technique with 5 steps. Step 1 shows 10 microliters of Immuno-Magnetic-Particles and 3 microliters of sample being pipetted into one cuvette. Step 2 shows 30 seconds later, 65 microliters of fluoresceinated capture and 65 microliters of alkaline phosphatase labeled marker antibody are added to the cuvette. Step 3 shows 15 minutes of incubation, step 4 shows washing four times, and step 5 shows adding substrate and starting readout, with the final result after 23 minutes.
Image /page/0/Figure/11 description: This image contains text describing a figure. The text states that the response read is directly proportional to the schematic representation of the Technicon Immuno 1 Myoglobin Assay. The figure is labeled as Fig. 1.
1
concentration of Myoglobin in a sample. A Cubic Fit Through Zero is used to calculate the dose response curve. The assay is depicted schematically in fig. 1.
The assay has a range of 0 to 3000 ng/mL with a sensitivity of 1.8 ng/mL; six calibrators with Myoglobin concentrations of 0, 60, 180, 600, 1500 and 3000 ng/mL are provided.
A dose response curve is shown in fig. 2.
Image /page/1/Figure/3 description: The image shows a calibration curve for Myoglobin using Technicon Immuno 1. The graph plots concentration in ng/mL on the y-axis against AU/min on the x-axis, displaying a linear relationship. Data pairs are provided, showing values such as 0 ng/mL corresponding to 0.0019 AU/min and 3000 ng/mL corresponding to 3.1391 AU/min.
Fig. 2 Calibration Curve of the Technicon Immuno 1 Myoglobin Assay
ASSAY PERFORMANCE
Imprecision
Total imprecision data was obtained by analyzing human serum controls on two Immuno 1 instruments on 20 different days. Two separate lots of reagents and calibrators were used. Both reagent and calibrator combinations on both instruments were tested with two different lots of magnetic particles. The total number of replicates for each level was 160. The calibration was only performed when a new reagent/ calibrator lot or particle lot combination was implemented on a machine.
2
| Table 1: Imprecision of Immuno 1 Myoglobin Assay
Data was collected on two Systems over twenty days with four replicates on each day on each
| system | |||||
|---|---|---|---|---|---|
| Specimen | Total Imprecision (n= 160) | Within run imprecision (mean) | |||
| Average | |||||
| [ng/mL] | Std Dev | ||||
| [ng/mL] | CV | ||||
| [%] | Std Dev | ||||
| [ng/mL] | CV | ||||
| [%] | |||||
| Sample 1 | 14.8 | 0.8196 | 5.5 | 0.3081 | 2.1 |
| Sample 2 | 52.6 | 1.9084 | 3.6 | 0.77925 | 1.5 |
| Sample 3 | 75.6 | 2.9831 | 3.9 | 1.06855 | 1.4 |
| Sample 4 | 131.3 | 4.6636 | 3.6 | 2.28195 | 1.7 |
| Sample 5 | 247 | 10.9436 | 4.4 | 4.47045 | 1.8 |
| Sample 6 | 278.1 | 8.2182 | 3.0 | 3.53275 | 1.3 |
| Sample 7 | 639.7 | 23.0701 | 3.6 | 11.3425 | 1.8 |
| Sample 8 | 1557.6 | 56.46 | 3.6 | 21.4224 | 1.4 |
| Sample 9 | 2718.9 | 91.3937 | 3.4 | 44.90395 | 1.7 |
Correlation with Immuno 1 Myoglobin results with Behring Nephelometer A
A total of 100 serum and plasma samples with Behring Nephelometer (BNA) values in the range of 21 to 2660 ng/mL (BNA) were tested with the Behring Nephelometer A and the Immuno 1 Myoglobin assay. The correlation equation according to Bablock-Passing was
y = 1.02 × x + 1.05
(y is Immuno 1 Myoglobin assay; x is Behring Nephelometer A Myoglobin assay).
| Calculation of Regression Line : | |||||
|---|---|---|---|---|---|
| Number of Samples : | 100 | ||||
| Slope (b) : | 1.02 | ||||
| Limits : | 0.98 | 1.06 | Sampletype : | all sample | |
| codes | |||||
| Intercept (a) : | 1.05 | ||||
| Limits : | -3.2 | 4.5 | |||
| Confidence of Correlation : | 0.99314 |
3
Image /page/3/Figure/0 description: This figure is a scatter plot comparing BNA and Immuno 1, with values ranging from 0 to 4'000 on both axes. The data points are clustered along a diagonal, indicating a positive correlation between the two variables. There are also three trend lines plotted on the graph.
ﻣﺴﺘﻘ
Fig. 3 Correlation Plot of Immuno 1 Myoglobin Results versus Behring Nephelometer A
results
4
TEST.XLG (METHOD.XLD)
Method Comparison acc. to Bablok-Passing
Methods: Immuno 1 Myoglobin vs. Behring N-Latex Reagents (BNA)
Serum and Plasma Samples
Image /page/4/Figure/7 description: The image shows a scatter plot of 'Immuno 1' versus 'BNA', with data points, a regression line, and an identity line. The regression line has a slope of 1.04110 and an intercept of -0.98356. The number of samples is 54, and the sample type is 'all sample codes'. The confidence of correlation is 0.96814.
5
Interference
For all interference measurements a +2 Pool and a -2 Pool was prepared. The +2 Pool was made from a solution of Myoglobin in serum with a concentration of approximately 180 µg/l (double of the concentration at the medical decision point) being diluted 1+1 with a solution of the potentially interfering substance in Myoglobin-stripped serum at a concentration twice as high as required. This yields a Myoglobin concentration at the medical decision level with the required interferantconcentration. The -2 Pool was made up from the same Myoglobin solution, but this time being diluted 1+1 with stripped serum containing no interferant. So two solutions of exactly identical Myoglobin concentration were obtained, one containing no interferent, the other with the required high concentration. The 0-Pool was obtained mixing equivalent amounts of the +2- and the -2-Pool while the -1- and +1-Pool were prepared from equal quantities of the 0-Pool and the -2- respectively the +2-Pool.
- Bilirubin
| Bilirubin: | -2 Pool: | 0 mg/ dL |
|---|---|---|
| +2 Pool | 25 mg/ dL |
Results:
| Pool | conc. (meas.) | % of -2 pool |
|---|---|---|
| 2- | 90.6 | 100.0 |
| 1- | 90.6 | 100.0 |
| 0 | 91.3 | 100.8 |
| 1+ | 91.5 | 101 |
| 2+ | 90.9 | 100.3 |
- Albumin
| Albumin: | -2 Pool: | 0 mg/mL |
|---|---|---|
| +2 Pool: | 6.5 g/dL |
Results:
| Pool | conc (meas.) | % of -2 Pool |
|---|---|---|
| 2- | 87.1 | 100.0 |
| 1- | 87.1 | 100.0 |
| 0 | 87.9 | 100.9 |
| 1+ | 88.1 | 101.1 |
| 2+ | 88.4 | 101.5 |
6
- Hemoglobin
| Hemoglobin: | -2 Pool: 0 mg/ mL |
|---|---|
| +2 Pool: | 1 g/ dL |
Results:
| Pool | conc. (meas) | % of -2 Pool |
|---|---|---|
| 2- | 88 | 100.0 |
| 1- | 89.3 | 101.5 |
| 0 | 89.8 | 102 |
| 1+ | 88.1 | 100.1 |
| 2+ | 89.3 | 101.5 |
- Gamma Globulins
| BGG: | |
|---|---|
| -2 Pool: | 0 mg/dL |
| +2 Pool: | 5.3 g/dL |
Results:
)
)
conc. (meas.) = % of -2 Pool Pool Sale 100,0 82,7 2-101,7 84,1 1-102,3 84,6 0 95 78,6 1+ 103.5 85 ହ 2+
- Triglycerides
| Triglyceride Supertrate: | -2 Pool: | 0 g/ dL |
|---|---|---|
| +2 Pool: | - ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Results:
| Pool | conc. (meas.) | % of -2 Pool |
|---|---|---|
| 2- | 94,9 | 100,0 |
| 1- | 90,4 | 95,3 |
| 0 | 90 | 94.8 |
| 1+ | 89 | 93.8 |
| 2+ | 99.2 | 104.5 |
7
- Heparin
| Heparin: | -2 Pool: | 0 IU/mL (Serum) |
|---|---|---|
| +2 Pool: | 65 IU/mL (0.5 mg/mL) |
Results:
ﻠﻤﺴﺎ
| Pools | conc. (meas.) | % of -2 Pool |
|---|---|---|
| 2- | 85,9 | 100,0 |
| 1- | 85,8 | 99,9 |
| 0 | 85,8 | 99.9 |
| 1+ | 86.4 | 100,6 |
| 2+ | 87.2 | 101.5 |
- Citrate
| Trisodium Citrate, Dihydrate: -2 Pool: | 0 mg/ml |
|---|---|
| +2Pool: | 50 mg/mL |
Results:
| Pools | conc. (meas.) | % of -2 Pool |
|---|---|---|
| 2- | 92,4 | 100,0 |
| 1- | 90,8 | 98,3 |
| 0 | 91,5 | 99 |
| 1+ | 91,1 | 98,6 |
| 2+ | 88,7 | 96 |
- Urea and Creatine
| Urea and Creatine: | -2 Pool: | no Urea, no Creatine |
|---|---|---|
| +2 Pool: | 200 mg/ dL Urea, 2.5 mg/dL Creatine |
Results:
| Pools | conc. (meas.) | % of -2 Pool |
|---|---|---|
| 2- | 127,7 | 100,0 |
| 1- | 129,2 | 101,2 |
| 0 | 127,9 | 100,2 |
| 1+ | 127,5 | 99,8 |
| 2+ | 128.4 | 100.5 |
8
- Rheumatory Factor
0 IU/ mL Rheumatory Factor: -2 Pool: +2 Pool: 567 IU/ mL
Results:
| Pool | conc. (meas.) | % of -2 Pool |
|---|---|---|
| 2- | 95,9 | 100,0 |
| 1- | 96,1 | 100,2 |
| 0 | 98,1 | 102,3 |
| 1+ | 98,8 | 103 |
| 2+ | 99,6 | 103.9 |
Linearity
All control to check linearity pools were generated in a way, that a serum sample with a high Myoglobin level (+2 Pool) and a low sample (-2 Pool) were mixed in a ratio of 1 + 1. The 0 Pool thus generated was furtherly mixed with the same amount of the +2 respectively the -2 Pool to have the +1 and -1 Pool. By that procedure five equally spaced controls covering the whole assay range are generated. For data analysis a linear regression was calculated from the result of the -2, -1 and 0 Pools of each sample series. The expected results and the deviation from the measured values were calculated from the equation. The result is shown in the table below.
| Pool (Sample) | measured | calculated | dev (%) |
|---|---|---|---|
| -2 (A) | 18.7 | 19.5 | -3.9 |
| -1 (A) | 656.7 | 655.2 | 0.2 |
| 0 (A) | 1290.2 | 1291 | -0.1 |
| 1 (A) | 1855.7 | 1926.7 | -3.7 |
| 2 (A) | 2481.8 | 2562.5 | -3.1 |
| -2 (B) | 19.1 | 24.2 | -21 |
| -1 (B) | 659.9 | 649.7 | 1.6 |
| 0 (B) | 1270.2 | 1275.3 | -0.4 |
| 1 (B) | 1862.7 | 1900.8 | -2 |
| 2 (B) | 2439.2 | 2526.4 | -3.5 |
| -2 (C) | 19.1 | 20.4 | -6.5 |
| -1 (C) | 664.9 | 662.2 | 0.4 |
| 0 (C) | 1302.7 | 1304 | -0.1 |
| 1 (C) | 1891.6 | 1945.8 | -2.8 |
| 2 (C) | 2510.9 | 2587.6 | -3 |
9
Sample Dilution
For testing Sample Dilution of clinical serum and plasma samples a dilution series with Immuno 1 Sample Diluent B and Immuno 1 Myoglobin Calibrator Level 1 was run. The recovery of the undiluted sample was set to 100 %
| sample content
| % | Identification | AU/min | conc.(meas.) | conc.(calc) | recovery (%) |
|---|---|---|---|---|---|
| 100 | Serum | 1.1004 | 880.5 | 880.5 | 100 |
| 75 | Sample A | 0.7783 | 623.3 | 660.4 | 106.0 |
| 50 | 0.4671 | 426.6 | 440.3 | 103.2 | |
| 25 | 0.2536 | 205.1 | 220.1 | 107.3 | |
| 10 | 0.1013 | 81.6 | 88.1 | 108 | |
| 0 | 0.0027 | 0.6 | 0.0 | ||
| 100 | Serum | 2.7817 | 2420.1 | 2420.1 | 100 |
| 75 | Sample B | 2.2541 | 1881.2 | 1815.1 | 96.5 |
| 50 | 1.5296 | 1233 | 1210.1 | 98.1 | |
| 25 | 0.7516 | 602.1 | 605.0 | 100.5 | |
| 10 | 0.2922 | 236.2 | 242.0 | 102.5 | |
| 0 | 0.002 | 0.1 | 0.0 | ||
| 100 | Serum | 3.1881 | 2887.9 | 2887.9 | 100 |
| 75 | Sample C | 2.5717 | 2197.4 | 2165.9 | 98.6 |
| 50 | 1.7897 | 1456.1 | 1444.0 | 99.2 | |
| 25 | 0.9565 | 765.2 | 722.0 | 94.4 | |
| 10 | 0.3813 | 307.7 | 288.8 | 93.9 | |
| 0 | 0.0021 | 0.2 | 0.0 | ||
| 100 | Serum | 2.7268 | 2360.9 | 2360.9 | 100 |
| 75 | Sample D | 2.0877 | 1724.3 | 1770.7 | 102.7 |
| 50 | 1.4969 | 1205.5 | 1180.5 | 97.9 | |
| 25 | 0.7662 | 613.7 | 590.2 | 96.2 | |
| 10 | 0.2915 | 235.6 | 236.1 | 100.2 | |
| 0 | 0.0023 | 0.3 | 0.0 | ||
| 100 | Serum | 2.6725 | 2302.7 | 2302.7 | 100 |
| 75 | Sample E | 2.0673 | 1705.4 | 1727.0 | 101.3 |
| 50 | 1.456 | 1171.4 | 1151.4 | 98.3 | |
| 25 | 0.7215 | 578.2 | 575.7 | 99.6 | |
| 10 | 0.2689 | 217.5 | 230.3 | 105.9 | |
| 0 | 0.002 | 0.1 | 0.0 |
9
10
| Sample
| content % | Identification | AU/min | conc. (meas.) | conc. (calc) | dev. |
|---|---|---|---|---|---|
| 100 | Serum | 1.0525 | 859.7 | 859.7 | 100 |
| 75 | Sample A | 0.8022 | 659.3 | 644.8 | 97.8 |
| 50 | 0.5132 | 426.3 | 429.9 | 100.8 | |
| 25 | 0.2648 | 222.1 | 214.9 | 96.8 | |
| 10 | 0.0976 | 81 | 86.0 | 106.2 | |
| 0 | 0.0019 | -1.3 | 0.0 | ||
| 100 | Serum | 2.7167 | 2344.3 | 2344.3 | 100 |
| 75 | Sample B | 2.1286 | 1767.2 | 1758.2 | 99.5 |
| 50 | 1.4933 | 1217.3 | 1172.2 | 96.3 | |
| 25 | 0.7267 | 598.8 | 586.1 | 97.9 | |
| 10 | 0.2955 | 247.5 | 234.4 | 94.7 | |
| 0 | 0.003 | -0.3 | 0.0 | ||
| 100 | Serum | 3.0948 | 2765.1 | 2765.1 | 100 |
| 75 | Sample C | 2.4005 | 2023.7 | 2073.8 | 102.5 |
| 50 | 1.7318 | 1417.3 | 1382.6 | 97.6 | |
| 25 | 0.9207 | 754.1 | 691.3 | 91.7 | |
| 10 | 0.3701 | 309.3 | 276.5 | 89.4 | |
| 0 | 0.0018 | -1.4 | 0.0 | ||
| 100 | Serum | 2.8607 | 2499.2 | 2499.2 | 100 |
| 75 | Sample D | 2.1077 | 1748.1 | 1874.4 | 107.2 |
| 50 | 1.4938 | 1217.7 | 1249.6 | 102.6 | |
| 25 | 0.751 | 618.3 | 624.8 | 101.1 | |
| 10 | 0.2835 | 237.7 | 249.9 | 105.1 | |
| 0 | 0.0019 | -1.3 | 0.0 | ||
| 100 | Serum | 2.7182 | 2345.6 | 2345.6 | 100 |
| 75 | Sample E | 2.1273 | 1766 | 1759.2 | 99.6 |
| 50 | 1.4916 | 1215.9 | 1172.8 | 96.5 | |
| 25 | 0.7647 | 629.3 | 586.4 | 93.2 | |
| 10 | 0.297 | 248.8 | 234.6 | 94.3 | |
| 0 | 0.0021 | -1.1 | 0.0 |
| Dilution of Plasma Samples with Immuno 1 Sample diluent B | |||||
|---|---|---|---|---|---|
| Sample content | |||||
| [%] | Identification | AU/min | conc. (meas) | conc (calc) | dev (%) |
| 100 | Plasma | 1.44 | 1224.1 | 1224.1 | 100 |
| 75 | Sample AA | 1.0586 | 898 | 918.075 | 102.2 |
10
11
| Sample content
| [%] | Identification | AU/min | conc. (meas) | conc (calc) | dev (%) |
|---|---|---|---|---|---|
| 50 | 0.6935 | 591.2 | 612.05 | 103.5 | |
| 25 | 0.3398 | 292.3 | 306.025 | 104.7 | |
| 10 | 0.1379 | 118.7 | 122.41 | 103.1 | |
| 0 | 0.0024 | 0.1 | 0 | - | |
| 100 | Plasma | ||||
| Sample BB | 2.6022 | 2332.7 | 2332.7 | 100 | |
| 75 | Sample BB | 2.0189 | 1747.1 | 1749.525 | 100.1 |
| 50 | 1.3546 | 1150.3 | 1166.35 | 101.4 | |
| 25 | 0.6843 | 583.5 | 583.175 | 99.9 | |
| 10 | 0.2568 | 221.3 | 233.27 | 105.4 | |
| 0 | 0.0023 | -0.1 | 0 | - | |
| 100 | Plasma | ||||
| Sample CC | 2.5736 | 2302.1 | 2302.1 | 100 | |
| 75 | Sample CC | 1.9753 | 1705.9 | 1726.575 | 101.2 |
| 50 | 1.361 | 1155.8 | 1151.05 | 99.6 | |
| 25 | 0.6662 | 568.3 | 575.525 | 101.3 | |
| 10 | 0.2714 | 233.9 | 230.21 | 98.4 | |
| 0 | 0.0022 | -0.2 | 0 | - | |
| 100 | Plasma | ||||
| Sample DD | 1.2854 | 1090.7 | 1090.7 | 100 | |
| 75 | Sample DD | 0.9627 | 817.3 | 818.025 | 100.1 |
| 50 | 0.635 | 542.1 | 545.35 | 100.6 | |
| 25 | 0.3104 | 267.3 | 272.675 | 102 | |
| 10 | 0.1269 | 109.1 | 109.07 | 100 | |
| 0 | 0.002 | -0.4 | 0 | - | |
| 100 | Plasma | ||||
| Sample EE | 1.62 | 1382.2 | 1382.2 | 100 | |
| 75 | Sample EE | 1.2144 | 1030.1 | 1036.65 | 100.6 |
| 50 | 0.8063 | 685.9 | 691.1 | 100.8 | |
| 25 | 0.3932 | 337.8 | 345.55 | 102.3 | |
| 10 | 0.1604 | 138.2 | 138.22 | 100 | |
| 0 | 0.0032 | -0.1 | 0 | - |
| Dilution of Plasma Samples with Immuno 1 Calibrator Level 1 | |||||
|---|---|---|---|---|---|
| Sample content | |||||
| % | Identification | AU/min | conc (meas) | conc (calc) | dev (%) |
| 100 | Plasma | 1.4613 | 1216.1 | 1216.1 | 100 |
| 75 | Sample AA | 1.1144 | 929.1 | 912.075 | 98.2 |
| 50 | 0.814 | 683.6 | 608.05 | 88.9 | |
| 25 | 0.3588 | 307 | 304.025 | 99 | |
| 10 | 0.1268 | 108.8 | 121.61 | 111.8 | |
| 0 | 0.0025 | -0.1 | 0 | - |
. D
)
11
12
| Sample content | Identification | AU/min | conc (meas) | conc (calc) | dev (%) |
|---|---|---|---|---|---|
| % | |||||
| 100 | Plasma | 2.724 | 2392.9 | 2392.9 | 100 |
| 75 | Sample BB | 2.1735 | 1843.6 | 1794.675 | 97.3 |
| 50 | 1.4542 | 1210.1 | 1196.45 | 98.9 | |
| 25 | 0.7596 | 639.2 | 598.225 | 93.5 | |
| 10 | 0.283 | 242.9 | 239.29 | 98.5 | |
| 0 | 0.0023 | -0.2 | 0 | ||
| 100 | Plasma | 2.7637 | 2435.5 | 2435.5 | 100 |
| 75 | Sample CC | 2.1392 | 1811.5 | 1826.625 | 100.8 |
| 50 | 1.4943 | 1243.9 | 1217.75 | 97.9 | |
| 25 | 0.7273 | 612.7 | 608.875 | 99.4 | |
| 10 | 0.2993 | 256.7 | 243.55 | 94.9 | |
| 0 | 0.0023 | -0.3 | 0 | ||
| 100 | Plasma | 1.3432 | 1117.6 | 1117.6 | 100 |
| 75 | Sample DD | 1.0524 | 878.4 | 838.2 | 95.4 |
| 50 | 0.6883 | 580.7 | 558.8 | 96.2 | |
| 25 | 0.3372 | 288.8 | 279.4 | 96.7 | |
| 10 | 0.1365 | 117.3 | 111.76 | 95.3 | |
| 0 | 0.0021 | -0.4 | 0 | ||
| 100 | Plasma | 1.6146 | 1345.7 | 1345.7 | 100 |
| 75 | Sample EE | 1.2409 | 1033 | 1009.275 | 97.7 |
| 50 | 0.8323 | 698.6 | 672.85 | 96.3 | |
| 25 | 0.3987 | 340.5 | 336.425 | 98.8 | |
| 10 | 0.1619 | 139.1 | 134.57 | 96.7 | |
| 0 | 0.0021 | -0.4 | 0 |
ﻟﺮ
12
13
Hook Effect
ﻤﺴﺎ
ﻣﺴﺎ
Samples with Myoglobin concentrations up to 1 Million ng/mL were assayed with the Technicon Immuno 1 Myoglobin Assay. The assay will not erroneously compute raw data to concentrations within the calibration range of the assay as long as the Myoglobin content in the sample is less than 150,000 ng/mL. In the following figure there is a graphical representation of the expected concentrations against the reported for antigen levels between 500 ng/mL and 1 Million ng/mL.
Image /page/13/Figure/2 description: The image shows a graph with "ng/mL Myoglobin (expected)" on the x-axis and "ng/mL Myoglobin (measured)" on the y-axis. The graph shows a range labeled "Assay Range" between 100 and 10000 on the x-axis and 100 and 10000 on the y-axis. There is also a range labeled "Raw Data out of Range" between 10000 and 100000 on the x-axis. The graph shows a line with data points that increases from left to right, then decreases from left to right.
Fig. 4 Concentrations reported by the Immuno 1 Myoglobin assay against expected concentrations. There are no results reported if they above the dashed line in Fig. 4.
14
Recovery
Known amounts of Myoglobin Solution were spiked into four clinical samples, two serum samples, two plasma samples. For serum the recoveries were ranging from 96.5 to 105.2 %; for plasma the recoveries are between 97.7 and 103%. For the recoveries of spiked antigen in plasma it is important to also use Myoglobin containing plasma as the spiking material. Serum- of buffer-based material may lead to deviations from the expected.
| Serum (PEY 2795) | |||
|---|---|---|---|
| Sample | Expected | found | recovery |
| Serum | 39.1 | 39.1 | 100.0 |
| Sample α | 77.2 | 78.1 | 101.2 |
| 651 | 672.6 | 103.3 | |
| 1224 | 1250.1 | 102.1 | |
| 1798 | 1757.7 | 97.8 | |
| 2371 | 2377.2 | 100.3 | |
| Serum | 38.5 | 38.5 | 100.0 |
| Sample β | 77.2 | 77.4 | 100.3 |
| 651 | 685 | 105.2 | |
| 1224 | 1223.6 | 100.0 | |
| 1798 | 1735.1 | 96.5 | |
| 2371 | 2331.8 | 98.3 |
| Plasma (PEY 2795) | |||
|---|---|---|---|
| Sample | expected | found | recovery |
| Plasma | 24.8 | 24.8 | 100.0 |
| Sample γ | 77 | 78.1 | 101.4 |
| 843.45 | 860.6 | 102.0 | |
| 1609.9 | 1624.3 | 100.9 | |
| 2376.35 | 2326.6 | 97.9 | |
| 3142.8 | 3180.4 | 101.2 | |
| Plasma | 31.3 | 31.3 | 100.0 |
| Sample δ | 83.5 | 81.6 | 97.7 |
| 758.45 | 780.9 | 103.0 | |
| 1433.4 | 1459.2 | 101.8 | |
| 2108.35 | 2078 | 98.6 | |
| 2783.3 | 2782 | 100.0 |
15
Expected Values
)
Samples from 77 non AMI individuals were assayed and gave the distribution of results shown in Fig. 4.
It was found that 98% of of the values were 88 ng/mL or less.
Immuno 1 Myoglobin: Normal Distribution
Image /page/15/Figure/4 description: This image is a graph titled "Fig. 5 Technicon Immuno 1 Myoglobin Assay: Normal". The graph shows concentration in ng/mL on the x-axis, ranging from 0 to 156. The y-axis shows a scale from 0 to 10. The graph shows a series of vertical bars, with the highest bars between 12 and 24 ng/mL.
Distribution
Minimum Detectable Concentration
The minimum detectable concentration was measured in 32 different runs on four different days using two different lots of reagents, calibrators and magnetic particles. The L1 calibrator containing no Myoglobin was measured 576 times all together. Calculated from the mean zero absorption plus two standard deviations the minimum detectable dose was determined as 1.8 ng/ml..