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creatinine [2025/01/27 09:51] – admin | creatinine [2025/01/27 10:54] (current) – admin | ||
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- | [[clinical_biochemistry_section|Home]] | + | |[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]| |
- | **Purpose of examination: | + | |
+ | **1.Purpose of examination: | ||
* Creatinine | * Creatinine | ||
- | **Responsibility and Authority: | + | **2.Responsibility and Authority: |
* Calibration: | * Calibration: | ||
* Quality Control: Technician | * Quality Control: Technician | ||
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* Overall Monitoring: Quality Manager | * Overall Monitoring: Quality Manager | ||
- | **Sample Details: | + | **3.Sample Details: |
- Type of Sample: Serum, | - Type of Sample: Serum, | ||
- Type of container and additives: Plain without any additives | - Type of container and additives: Plain without any additives | ||
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- Storage: 24 hours at 2-8° C | - Storage: 24 hours at 2-8° C | ||
- | **Required Equipment: | + | **4.Required Equipment: |
* Centrifuge, Auto-Pipette, | * Centrifuge, Auto-Pipette, | ||
- | + | **5.Required reagents:** | |
- | * **Required reagents:** | + | |
* R1. Sodium hydroxide 0.8 mol/L | * R1. Sodium hydroxide 0.8 mol/L | ||
* R2. Picric acid 24 mmol/L | * R2. Picric acid 24 mmol/L | ||
* **Reagent Handling** | * **Reagent Handling** | ||
* Remove any air bubbles present in the reagents with a new applicator stick, or allow the reagents to settle at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove bubbles | * Remove any air bubbles present in the reagents with a new applicator stick, or allow the reagents to settle at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove bubbles | ||
- | **Reagent Storage and stability: | + | **6.Reagent Storage and stability: |
* Unopened reagent stable at 15-30°C until expiration date. | * Unopened reagent stable at 15-30°C until expiration date. | ||
* On board System temperature reagent is stable for 05 days | * On board System temperature reagent is stable for 05 days | ||
* Instability or deterioration should be suspected if there are precipitates, | * Instability or deterioration should be suspected if there are precipitates, | ||
- | **Calibration Procedure: | + | **7.Calibration Procedure: |
* Consolidated Chemistry | * Consolidated Chemistry | ||
* **Frequency: | * **Frequency: | ||
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- If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary. | - If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary. | ||
- | **Quality control Procedure: | + | **8.Quality control Procedure: |
**Name:** Biorad Level 1 &2 | **Name:** Biorad Level 1 &2 | ||
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- Check IQC results, in case outliers call residents. | - Check IQC results, in case outliers call residents. | ||
- | **Principle of the procedure used for examinations: | + | **9.Principle of the procedure used for examinations: |
At an alkaline pH, creatinine in the sample reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine in the sample. | At an alkaline pH, creatinine in the sample reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine in the sample. | ||
- | **Sample Preparation: | + | **10.Sample Preparation: |
* Required Sample Volume: 150 µl of the sample | * Required Sample Volume: 150 µl of the sample | ||
* Temperature: | * Temperature: | ||
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- Put respected carrier in RSH rack | - Put respected carrier in RSH rack | ||
- | ** Performance Characteristics: | + | **11.Performance Characteristics: |
* Linearity: | * Linearity: | ||
* The limit of detection (LOD): 0.05 mg/dL | * The limit of detection (LOD): 0.05 mg/dL | ||
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* Unit: mg/dl | * Unit: mg/dl | ||
- | **Normal and critical ranges:** | + | **12.Normal and critical ranges:** |
^1-5 y^0.04-0.45^mg/ | ^1-5 y^0.04-0.45^mg/ | ||
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^Adult Female^0.45-0.75^mg/ | ^Adult Female^0.45-0.75^mg/ | ||
- | **Laboratory Clinical interpretation: | + | **13.Laboratory Clinical interpretation: |
* Measurement of serum creatinine is used to diagnose and monitor acute and chronic renal disease, estimate glomerular filtration rate (GFR), or assess the status of renal dialysis patients. | * Measurement of serum creatinine is used to diagnose and monitor acute and chronic renal disease, estimate glomerular filtration rate (GFR), or assess the status of renal dialysis patients. | ||
- | **Interference and cross reaction:** | + | **14.Interference and cross reaction:** |
The Following analytes were tested up to the levels indicated at Creatinine concentrations of 0.14mg/dl and 5.03 mg/dl, and found not to interfere: | The Following analytes were tested up to the levels indicated at Creatinine concentrations of 0.14mg/dl and 5.03 mg/dl, and found not to interfere: | ||
* No interference from Bilirubin up to 30 mg/dL | * No interference from Bilirubin up to 30 mg/dL | ||
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* No interference from Protein up to 10.6 g/dL | * No interference from Protein up to 10.6 g/dL | ||
- | * **Potential source of variation: | + | **15.Potential source of variation: |
* **Turn around time (TAT):** | * **Turn around time (TAT):** | ||
* Routine: 6.0 hours | * Routine: 6.0 hours | ||
* Urgent: 2.0 hours | * Urgent: 2.0 hours | ||
- | * **Recording of observation: | + | **16.Recording of observation: |
* Software backup | * Software backup | ||
* Machine raw data | * Machine raw data | ||
- | **Storage & Disposal of waste:** Follow storage & discard procedure | + | **17.Storage & Disposal of waste:** Follow storage & discard procedure |
- | **Environmental & Safety control:** | + | **18.Environmental & Safety control:** |
**Reagent R1** contains sodium hydroxide that Causes severe skin burns and eye Damage & May be corrosive to metals | **Reagent R1** contains sodium hydroxide that Causes severe skin burns and eye Damage & May be corrosive to metals | ||
- | **Precautions: | + | **19.Precautions: |
- Wear protective gloves / protective clothing / eye protection | - Wear protective gloves / protective clothing / eye protection | ||
- Do not breathe mist / vapors / spray | - Do not breathe mist / vapors / spray | ||
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- Keep only in original container | - Keep only in original container | ||
- | **Response** | + | **20.Response** |
- IF SWALLOWED: Rinse mouth. Do NOT induce vomiting | - IF SWALLOWED: Rinse mouth. Do NOT induce vomiting | ||
- IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing | - IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing | ||
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- | **References: | + | **21.References: |
- Thomas L, editor. Clinical Laboratory Diagnostics: | - Thomas L, editor. Clinical Laboratory Diagnostics: | ||
- Jaffe M. Ueber den Niederschlag, | - Jaffe M. Ueber den Niederschlag, | ||
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- Fabiny DL, Ertingshausen G. Automated reaction-rate method for determination of serum creatinine with the CentrifiChem. Clin Chem 1971; | - Fabiny DL, Ertingshausen G. Automated reaction-rate method for determination of serum creatinine with the CentrifiChem. Clin Chem 1971; | ||
- Soldin S, Henderson L, Hill G. The effect of bilirubin and ketones on reaction rate methods for the measurement of creatinine. Clin Biochem 1978: | - Soldin S, Henderson L, Hill G. The effect of bilirubin and ketones on reaction rate methods for the measurement of creatinine. Clin Biochem 1978: | ||
+ | |||
+ | |**Printed copy of this document is considered uncontrolled.** It should be compared with controlled electronic copy before use| | ||
+ | |||
+ | ^ Name of Laboratory : Laboratory Services Sir T. Hospital (LSSTH), | ||
+ | ^Document No.1^**Document Name**: Creatinine Examination Procedure^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^ | ||
+ | ^Issue No. : 01^Issue Date : | ||
+ | ^Amend No.^ Amend Date ^Prepared by: Section Incharge^Approved & Issued by: HOD, | ||