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amylase [2025/01/28 05:54] – created adminamylase [2025/01/28 05:59] (current) – admin
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 **1.Purpose of examination:**  **1.Purpose of examination:** 
-● Amylase  estimation from serum or plasma by Enzymatic/Colorimetric Method.+Amylase  estimation from serum or plasma by Enzymatic/Colorimetric Method.
  
-2.Responsibility and Authority:  +**2.Responsibility and Authority:**  
-● Calibration: Technician  +  * Calibration: Technician  
-● Quality Control: Technician  +  * Quality Control: Technician  
-● Routine operation: Technician  +  * Routine operation: Technician  
-● Overall Monitoring: Quality Manager+  * Overall Monitoring: Quality Manager
  
-3.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
  
-4.Required reagents:+**5.Required reagents:**
 ● R1. α-glucosidase 16.000 KU/L. ● R1. α-glucosidase 16.000 KU/L.
 ● R2. Ethylidene-4-NP-G7 (EPS) 6.501 g/L. ● R2. Ethylidene-4-NP-G7 (EPS) 6.501 g/L.
  
-5.Reagent Handling +**6.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 
-**6.Reagent Storage and stability**+ 
 +**7.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 30 days On board System temperature reagent is stable for 30 days
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 contamination, turbidity, or if calibration or controls do not meet the appropriate criteria. contamination, turbidity, or if calibration or controls do not meet the appropriate criteria.
  
-7.Calibration Procedure: +**8.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:**
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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.
  
-**8.Quality control Procedure:**+**9.Quality control Procedure:**
   * Name: Bio Rad Level 1 &2   * Name: Bio Rad Level 1 &2
   * Frequency: As per Quality Control Procedure   * Frequency: As per Quality Control Procedure
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   - Check IQC results, in case outliers call residents.   - Check IQC results, in case outliers call residents.
  
-**9.Principle of the procedure used for examinations:**+**10.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.
  
  
-**10.Sample Preparation:**+**11.Sample Preparation:**
   * Required SampleVolume: 150 µl of the sample    * Required SampleVolume: 150 µl of the sample 
   * Temperature: 37°    * Temperature: 37° 
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   - Put respected carrier in RSH rack   - Put respected carrier in RSH rack
  
-**11.Performance Characteristics:** +**12.Performance Characteristics:** 
   * Linearity:   3 to 3300 U/L   * Linearity:   3 to 3300 U/L
   * The limit of detection (LOD): 1 U/L   * The limit of detection (LOD): 1 U/L
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 ^Adult^28-100^U/L ^Adult^28-100^U/L
  
-**12.Laboratory Clinical interpretation:**+**13.Laboratory Clinical interpretation:**
 Amylase is used primarily in the diagnosis of acute pancreatitis. Acute pancreatitis is a reversible inflammation due to enzymatic necrosis. The most common cause of acute pancreatitis is gallstones. The second most common cause is heavy alcohol consumption. Serum amylase elevation and concomitant urine amylase elevation is seen in patients with acute pancreatitis. Amylase is used primarily in the diagnosis of acute pancreatitis. Acute pancreatitis is a reversible inflammation due to enzymatic necrosis. The most common cause of acute pancreatitis is gallstones. The second most common cause is heavy alcohol consumption. Serum amylase elevation and concomitant urine amylase elevation is seen in patients with acute pancreatitis.
  
-**13.Interference and cross reaction:**+**14.Interference and cross reaction:**
 The Following analytes were tested up to the levels indicated at Creatinine concentrations of(approximately 50 U/L and 200 U/L). mg/dl, and found not to interfere: The Following analytes were tested up to the levels indicated at Creatinine concentrations of(approximately 50 U/L and 200 U/L). mg/dl, and found not to interfere:
 Avoid contaminents like saliva,cough , since these contain many units of amylase which might effect the reagent for color development. Avoid contaminents like saliva,cough , since these contain many units of amylase which might effect the reagent for color development.
  
-**14.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
  
-**15.Recording of observation:**+**16.Recording of observation:**
   * Software backup    * Software backup 
   * Machine raw data   * Machine raw data
  
-**16.Storage & Disposal of waste:** Follow storage & discard procedure+**17.Storage & Disposal of waste:** Follow storage & discard procedure
  
-**17.Environmental & Safety control:**+**18.Environmental & Safety control:**
 Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations. Contact with acids liberates very toxic gas. Dispose of contents / container in accordance with local regulations.
  
-**18.References**:+**19.References**:
   - Tietz NW, Huang WY, Rauh DF, et al. Laboratory tests in the differential diagnosis of hyperamylasemia. Clin Chem 1986 32(2):301-307   - Tietz NW, Huang WY, Rauh DF, et al. Laboratory tests in the differential diagnosis of hyperamylasemia. Clin Chem 1986 32(2):301-307
   - 6 Junge W. Troge B, Klein G, et al. Evaluation of a New Assay for Pancreatic Amylase: Performance Characteristics and Estimation of Reference Intervals Clin Biochem 1989,22 109-114   - 6 Junge W. Troge B, Klein G, et al. Evaluation of a New Assay for Pancreatic Amylase: Performance Characteristics and Estimation of Reference Intervals Clin Biochem 1989,22 109-114