Submitted:
28 April 2024
Posted:
29 April 2024
You are already at the latest version
Abstract
Keywords:
1. Introduction
2. Materials and Methods
2.1. Chemicals and Reagents
2.2. Instrumentation and Measurement Platform


2.3. Colorimetric Detection of Albumin and Creatinine
2.4. MYµALBUMIN Detector Linearity
2.5. Measurement of Albumin and Creatinine in Urine Samples
2.6. Validation of Test Performance of MYµALBUMIN
2.6.1. Calibration Curves
2.6.2. Accuracy
2.6.3. Precision
2.6.4. Limit of Quantification
2.7. Application of MYµALBUMIN to Clinical Samples
2.8. Statistical Analysis
3. Results
3.1. Validation of Test Performance of MYµALBUMIN Device
3.1.1. Calibration Curves
3.1.2. Accuracy
3.1.3. Precision
3.1.4. Limit of Quantification
3.2. Application to Clinical Samples
4. Discussion
5. Conclusions
6. Patents
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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| Composition | Molecular formula | Molecular weight (g/mol) | Final concentration (mM) |
|---|---|---|---|
| Sodium sulfate anhydrous | Na2SO4 | 142.04 | 9 |
| Trisodium citrate dehydrate | Na3C6H5O7·2H2O | 294.1 | 5 |
| Urea | CH4N2O | 60.06 | 200 |
| Potassuium chloride | KCl | 74.55 | 30 |
| Sodium chloride | NaCl | 58.44 | 54 |
| Calcium chloride | CaCl2 | 110.99 | 3 |
| Ammonium chloride | NH4Cl | 53.49 | 15 |
| Magnesium sulfate heptahydrate | MgSO4·7H2O | 246.47 | 2 |
| Sodium phosphate monobasic monohydrate | NaH2PO4·H2O | 137.99 | 3.6 |
| Sodium phosphate dibasic heptahydrate | Na2HPO4·7H2O | 268.03 | 0.4 |
| Sodium bicarbonate | NaHCO₃ | 84.01 | 2 |
| Disodium oxalate | Na2C2O4 | 134 | 0.1 |
| Albumin concentration added (mg/L) | Precision (%CV) | Accuracy (%DVM) | ||
|---|---|---|---|---|
| Intraday | Interday | Intraday | Interday | |
| MYµALBUMIN | ||||
| 10 | 2.52 | 4.58 | 1.43 | 4.29 |
| 40 | 1.34 | 3.02 | 2.36 | 1.07 |
| 60 | 1.44 | 2.75 | -0.90 | -1.57 |
| Spectrophotometer | ||||
| 10 | 2.86 | 3.77 | 3.51 | 6.22 |
| 40 | 0.30 | 1.00 | 1.96 | 2.50 |
| 60 | 1.42 | 0.87 | -0.95 | -0.95 |
| Creatinine concentration added (mg/L) | Precision (%CV) | Accuracy (%DVM) | ||
|---|---|---|---|---|
| Intraday | Interday | Intraday | Interday | |
| MYµALBUMIN | ||||
| 0.25 | 1.21 | 12.69 | 5.42 | -2.82 |
| 1 | 1.08 | 4.54 | 4.77 | 1.03 |
| 2 | 1.35 | 3.53 | -2.57 | -4.14 |
| Spectrophotometer | ||||
| 0.25 | 1.99 | 2.35 | 2.61 | 3.83 |
| 1 | 1.25 | 2.32 | -0.15 | 1.43 |
| 2 | 1.42 | 2.40 | -0.20 | 1.23 |
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