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Yumizen C1200 Creatinine PAP
Yumizen C1200 Creatinine PAP reagent is intended for the quantitative in vitro diagnostic determination of Creatinine in human serum, plasma and urine based on an enzymatic method using a multi- step approach ending with a photometric end-point reaction. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Yumizen C1200 Creatinine PAP reagent is intended for the quantitative in vitro diagnostic determination of Creatinine in human serum, plasma and urine based on an enzymatic method using a multi- step approach ending with a photometric end-point reaction.
The Horiba ABX SAS Yumizen C1200 Creatinine PAP device is an in vitro diagnostic intended for the quantitative determination of Creatinine in human serum, plasma, and urine. Its performance was evaluated through various analytical studies to demonstrate substantial equivalence to its predicate device, the ABX Pentra Enzymatic Creatinine CP.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from "within specifications") | Reported Device Performance (Yumizen C1200 Creatinine PAP) |
|---|---|---|
| Measuring Range | ||
| Serum Limit of Quantitation | Not explicitly stated, but implies the lowest concentration measurable with acceptable precision. | 0.11 mg/dL |
| Serum Linearity | Not explicitly stated, but implies correlation across range. | 0.04 - 19.93 mg/dL |
| Serum Measuring Range | Not explicitly stated, but likely the linear range with acceptable bias. | 0.11 - 16.95 mg/dL (up to 50.85 mg/dL with post-dilution) |
| Urine Limit of Quantitation | Not explicitly stated, but implies the lowest concentration measurable with acceptable precision. | 1.13 mg/dL |
| Urine Linearity | Not explicitly stated, but implies correlation across range. | 0.00 - 327.60 mg/dL |
| Urine Measuring Range | Not explicitly stated, but likely the linear range with acceptable bias. | 3.56 - 175 mg/dL (up to 525 mg/dL with post-dilution) |
| Accuracy and Precision (Instrument Variability - Serum/Plasma) | ||
| Within-run CV (low level) | ≤ 4.5 % | 0.5% (Yumizen N Multi Control), 1.4% (Sample 1) |
| Within-run CV (middle level) | ≤ 3.4 % | 0.3% (Yumizen P Multi Control), 0.5% (Sample 2) |
| Within-run CV (high level) | ≤ 1.8 % | 0.3% (Sample 3) |
| Total CV (low level) | ≤ 6.0 % | 1.5% (Yumizen N Multi Control), 2.9% (Sample 1) |
| Total CV (middle level) | ≤ 4.5 % | 1.3% (Yumizen P Multi Control), 2.0% (Sample 2) |
| Total CV (high level) | ≤ 2.4 % | 1.3% (Sample 3) |
| Accuracy and Precision (Lot to Lot Variability - Serum/Plasma) | ||
| Within-run CV (low level) | ≤ 4.5 % | Not reported separately, but "Within-Day (%CV)" for Sample 1 (1.7%) is shown |
| Within-run CV (middle level) | ≤ 3.4 % | Not reported separately, but "Within-Day (%CV)" for Sample 2 (0.9%) is shown |
| Within-run CV (high level) | ≤ 1.8 % | Not reported separately, but "Within-Day (%CV)" for Sample 4 (0.4%) is shown |
| Total CV (low level) | ≤ 6.0 % | 4.6% (Sample 1) |
| Total CV (middle level) | ≤ 4.5 % | 2.0% (Sample 2) |
| Total CV (high level) | ≤ 2.4 % | 0.5% (Sample 4) |
| Accuracy and Precision (Instrument Variability - Urine) | ||
| Within-run CV (low level) | ≤ 4.5 % | 1.2% (Sample 1) |
| Within-run CV (middle level) | ≤ 3.8 % | 0.8% (Sample 2) |
| Within-run CV (high level) | ≤ 3.8 % | 0.8% (Sample 3) |
| Total CV (low level) | ≤ 6.0 % | 4.2% (Sample 1) |
| Total CV (middle level) | ≤ 5.0 % | 4.3% (Sample 2) |
| Total CV (high level) | ≤ 5.0 % | 3.9% (Sample 3) |
| Accuracy and Precision (Lot to Lot Variability - Urine) | ||
| Within-run CV (low level) | ≤ 4.5 % | Not reported separately, but "Within-Day (%CV)" for Sample 1 (1.1%) is shown |
| Within-run CV (middle level) | ≤ 3.8 % | Not reported separately, but "Within-Day (%CV)" for Sample 2 (0.9%) is shown |
| Within-run CV (high level) | ≤ 3.8 % | Not reported separately, but "Within-Day (%CV)" for Sample 3 (0.9%) is shown |
| Total CV (low level) | ≤ 6.0 % | 2.1% (Sample 1) |
| Total CV (middle level) | ≤ 5.0 % | 1.3% (Sample 2) |
| Total CV (high level) | ≤ 5.0 % | 0.9% (Sample 3) |
| Interferences (Serum/Plasma) | Acceptable bias +/-10% of the value without interfering substances. | All listed interferents (Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Ascorbic Acid, Acetylsalicylic Acid, Ibuprofen, Acetaminophen, N-Acetylcystein, Glucose, Total Protein, Methyldopa, L-Dopa, Calcium Dobesilate) showed no interference higher than +/-10% at the specified concentrations. |
| Interferences (Urine) | Acceptable bias +/-10% of the value without interfering substances. | All listed interferents (Hemoglobin, Triglycerides, Direct Bilirubin, Ascorbic acid, N-Acetylcystein, pH) showed no interference higher than +/-10% at the specified concentrations. |
| Matrix Comparison (Serum/Lithium Heparin Plasma) | No significant difference between serum and plasma with heparin specimens. | Regression line: Intercept = -0.0281, Slope = 1.0008, r² = 0.995. This indicates no significant difference. |
| Method Comparison (Serum/Plasma vs. Predicate) | High correlation and acceptable agreement (implied by CLSI EP-9A3). | Regression line (Passing Bablok): Intercept = -0.0107, Slope = 0.9611, r² = 0.997. |
| Method Comparison (Urine vs. Predicate) | High correlation and acceptable agreement (implied by CLSI EP-9A3). | Regression line (Passing Bablok): Intercept = 0.2296, Slope = 0.9772, r² = 0.994. |
| Reagent Stability (Closed) | Stable up to expiry date. | 12 months (at 2-8°C). |
| Reagent Stability (Open, On-Board) | Stable for a specified period. | 6 weeks. |
| Reference Range Verification (Serum/Plasma - Men) | Consistent with established literature reference ranges. | Normal range: 0.67 - 1.17 mg/dL (consistent with Mazzachi et al. reference). |
| Reference Range Verification (Serum/Plasma - Women) | Consistent with established literature reference ranges. | Normal range: 0.51 - 0.95 mg/dL (consistent with Mazzachi et al. reference). |
2. Sample sizes used for the test set and the data provenance
- Measuring Range:
- Limit of detection and quantitation: Determined according to CLSI guideline EP17-A2. (Specific sample size not provided in the summary but typically involves multiple replicates of low-concentration samples).
- Linearity: Determined according to CLSI guideline EP06-A. (Specific sample size not provided in the summary but involves multiple concentrations with replicates).
- Accuracy and Precision:
- Instrument Variability (Serum/Plasma & Urine): 240 measurements (20x2x2 means 20 replicates for each of 3 samples, on 2 runs for 2 instruments over a certain period - or 20 days x 2 runs/day x 2 instruments). The samples were control materials and native samples.
- Lot-to-Lot Variability (Serum/Plasma & Urine): 90 measurements (3x5x2x3 implies 3 lots, 5 days, 2 runs/day, 3 samples). The samples were control materials and native samples.
- Interferences: Not explicitly stated, but typically involves testing known concentrations of interferents in base samples.
- Matrix Comparison: 84 paired samples (serum and lithium heparin plasma) from single donors.
- Method Comparison:
- Serum/Plasma: 103 native human serum samples. Data provenance: collected from CHU Nîmes (University Hospital Center). Retrospective (remnants).
- Urine: 129 native human urine samples. Data provenance: collected from routine clinical laboratory. Retrospective (remnants).
- Reagent Stability: Determined according to CLSI guideline EP25-A. (Specific sample size not provided).
- Reference Range Verification:
- Serum/Plasma - Men: 45 "normal samples" from a blood bank.
- Serum/Plasma - Women: 41 "normal samples" from a blood bank.
- Children & Urine: Verification could not be made due to lack of availability of samples from healthy pediatric patients/healthy people.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for this device, which is a quantitative in vitro diagnostic for creatinine levels. For such devices, ground truth is typically established by:
- A reference method (e.g., mass spectrometry) for accuracy studies.
- The established values of control materials.
- The results from a legally marketed predicate device (as seen in method comparison).
- Literature values for reference range verification.
4. Adjudication method for the test set
Not applicable. This is a quantitative diagnostic device, not one requiring expert adjudication of results.
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
Not applicable. This is a quantitative diagnostic device, not an AI-assisted diagnostic imaging device requiring human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a standalone in vitro diagnostic device (reagent and instrument system). Its performance described above (e.g., precision, accuracy, linearity, interference) represents the algorithm-only (device-only) performance, without human interpretation of the result influencing the quantitative output.
7. The type of ground truth used
- Measuring Range, Accuracy, Precision, Interferences, Reagent Stability: Internal specifications, established reference materials (controls), and recognized scientific methods (e.g., spiked samples for linearity and interference).
- Matrix Comparison: Paired samples from the same donor, with comparison between results from serum and plasma. The expectation is that the creatinine value should be the same across matrices for the same individual.
- Method Comparison: The predicate device's results (ABX Pentra Enzymatic Creatinine CP) served as the reference for comparison using method comparison studies (Passing Bablok regression).
- Reference Range Verification: Reference ranges cited in scientific literature (e.g., Mazzachi BC et al., Schlebusch Soldin SJ et al., Roberts WL et al.) were used for verification against measured values in "normal" samples.
8. The sample size for the training set
The document describes performance evaluation studies (validation) rather than a clear "training set" for an algorithm. For a device like this, the "training" usually refers to the development and optimization of the reagent formulation and instrument parameters. The specific sample sizes used for this developmental phase are not detailed in the summary. The provided sample sizes are for the analytical performance studies which are typically considered validation.
9. How the ground truth for the training set was established
As there isn't a "training set" in the context of machine learning, this question isn't directly applicable. For the development of an IVD like this, ground truth would be established during the R&D phase through:
- Using purified creatinine standards.
- Comparison with established and highly accurate reference methods (e.g., isotope dilution mass spectrometry, IDMS).
- Clinical samples with results from well-characterized, clinically accepted methods.
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