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creatinine [2025/01/27 09:26] – created admincreatinine [2025/01/27 10:54] (current) – admin
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 +|[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]|
  
  
 +                       Creatinine Examination Procedure 
 +**1.Purpose of examination:** 
 +  * Creatinine  estimation from serum or plasma by Kinetic Alkaline Picrate Method.
  
-**Purpose of examination:**  +**2.Responsibility and Authority:** 
-  * Unordered List ItemCreatinine  estimation from serum or plasma by Kinetic Alkaline Picrate Method. +
- +
-**Responsibility and Authority:** +
   * Calibration: Technician    * Calibration: Technician 
   * 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,  Plasma   - Type of Sample: Serum,  Plasma
   - Type of container and additives: Plain without any additives    - Type of container and additives: Plain without any additives 
-  - Patient Preparation: As per Primary Sample Collection Manual {{Sample collection manual}}+  - Patient Preparation: As per Primary Sample Collection Manual [[sample_collection_manual|]]
   - Stability: At Room temperature 18°–28°C (64°–82°F) stability ≤ 24 hours   - Stability: At Room temperature 18°–28°C (64°–82°F) stability ≤ 24 hours
   - Handling and transport: As per Primary Sample collection manual    - Handling and transport: As per Primary Sample collection manual 
   - Storage: 24 hours at 2-8° C   - Storage: 24 hours at 2-8° C
  
-**Required Equipment:** +**4.Required Equipment:** 
   * Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer   * Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer
- +**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, visible signs of leakage or contamination, turbidity, or if calibration or controls do not meet the appropriate criteria.   * Instability or deterioration should be suspected if there are precipitates, visible signs of leakage or contamination, turbidity, or if calibration or controls do not meet the appropriate criteria.
  
-**Calibration Procedure:**+**7.Calibration Procedure:**
   * Consolidated Chemistry  Calibrators(ConCC)   * Consolidated Chemistry  Calibrators(ConCC)
-**Frequency:**+  * **Frequency:**
   * Reagent lot change   * Reagent lot change
   * QC out of range   * QC out of range
   * After service or maintenance   * After service or maintenance
   * Replacement in any parts of Instrument   * Replacement in any parts of Instrument
 +
 **Procedure:** **Procedure:**
   - Start the equipment.WDI abbotte fully.docx   - Start the equipment.WDI abbotte fully.docx
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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
 +
 **Frequency:** As per Quality Control Procedure **Frequency:** As per Quality Control Procedure
  
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   - Store these aliquots at -15° C to -20° C.   - Store these aliquots at -15° C to -20° C.
   - Prior to use, make sure that aliquots should be at room temperature for at least 15 min.   - Prior to use, make sure that aliquots should be at room temperature for at least 15 min.
 +
 **Procedure to run IQC** **Procedure to run IQC**
   - Press Control order    - Press Control order 
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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 SampleVolume: 150 µl of the sample  +  * Required Sample Volume: 150 µl of the sample  
- ● Temperature: 37° +  * Temperature: 37° 
 Take 150-200µl of the sample from Primary tube to the secondary aliquot. Write the sample ID on the aliquot.  Take 150-200µl of the sample from Primary tube to the secondary aliquot. Write the sample ID on the aliquot. 
 +
 **Procedure to run Patient sample** **Procedure to run Patient sample**
   - Press Patient order    - Press Patient order 
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   - Put respected carrier in RSH rack   - Put respected carrier in RSH rack
  
-Performance Characteristics: +**11.Performance Characteristics:** 
   * Linearity:   0.20 to 37.00 mg/dL   * Linearity:   0.20 to 37.00 mg/dL
   * 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/dL^ ^1-5 y^0.04-0.45^mg/dL^
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 ^Adult Female^0.45-0.75^mg/dL^ ^Adult Female^0.45-0.75^mg/dL^
  
-**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 + 
-**Environmental & Safety control:**+**17.Storage & Disposal of waste:** Follow storage & discard procedure 
 + 
 +**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:** + 
-**Wear protective gloves / protective clothing / eye protection +**19.Precautions:** 
-Do not breathe mist / vapors / spray +  - Wear protective gloves / protective clothing / eye protection 
-Wash hands thoroughly after handling +  - Do not breathe mist / vapors / spray 
-Keep only in original container** +  - Wash hands thoroughly after handling 
-**Response** +  - Keep only in original container 
-**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. +**20.Response** 
-Continue rinsing +  - IF SWALLOWED: Rinse mouth. Do NOT induce vomiting 
-**IF ON SKIN (or hair):** Take off immediately all contaminated clothing. Rinse skin with water / shower.+  - IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.Continue rinsing 
 +  - IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water / shower. 
 **For Reagent R2:** **For Reagent R2:**
   * Explosive when dry   * Explosive when dry
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-References: +**21.References:** 
-Thomas L, editor. Clinical Laboratory Diagnostics: Use and Assessment of Clinical Laboratory Results. Frankfurt, Germany: TH- Books Verlagsgesellschaft mbH; 1998:366–374. +  - Thomas L, editor. Clinical Laboratory Diagnostics: Use and Assessment of Clinical Laboratory Results. Frankfurt, Germany: TH- Books Verlagsgesellschaft mbH; 1998:366–374. 
- Jaffe M. Ueber den Niederschlag, welchen Pikrinsaure in normalem Harn erzeugt und uber eine neue Reaction des Kreatinins. Hoppe Seylers Z Physiol Chem 1886;10:391–400. +  -  Jaffe M. Ueber den Niederschlag, welchen Pikrinsaure in normalem Harn erzeugt und uber eine neue Reaction des Kreatinins. Hoppe Seylers Z Physiol Chem 1886;10:391–400. 
-Folin O. Beitrag zur Chemie des Kreatinins und Kreatins Im Harne.Hoppe Seylers Z Physiol Chem 1904;41:223–242. +  - Folin O. Beitrag zur Chemie des Kreatinins und Kreatins Im Harne.Hoppe Seylers Z Physiol Chem 1904;41:223–242. 
-Fabiny DL, Ertingshausen G. Automated reaction-rate method for determination of serum creatinine with the CentrifiChem. Clin Chem 1971;17:696–700. +  - Fabiny DL, Ertingshausen G. Automated reaction-rate method for determination of serum creatinine with the CentrifiChem. Clin Chem 1971;17:696–700. 
-Soldin S, Henderson L, Hill G. The effect of bilirubin and ketones on reaction rate methods for the measurement of creatinine. Clin Biochem 1978:82–86.+  - Soldin S, Henderson L, Hill G. The effect of bilirubin and ketones on reaction rate methods for the measurement of creatinine. Clin Biochem 1978:82–86. 
 + 
 +|**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),Bhavnagar ^^^^ 
 +^Document No.1^**Document Name**: Creatinine Examination Procedure^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^ 
 +^Issue No. : 01^Issue Date :30/04/2024^Page No.^^ 
 +^Amend No.^ Amend Date ^Prepared by: Section Incharge^Approved & Issued by: HOD,Biochemistry^