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--- urea [2025/01/27 05:03] – admin
+++ urea [2025/01/27 10:54] (current) – admin
@@ Line 1: / Line 1: @@
-===== Urea Examination Procedure =====
+|[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]|
-^Name^Unique ID^Edition^Date of Edition^
-|Urea Examination Procedure|LSSTH/ | 01-03-2023|
-^Preparing authority^Approving authority^Review period^Review Date^
-|All teaching staff|Quality Manager|2 year|
-|**Printed copy of this document is considered uncontrolled.** It should be compared with controlled electronic copy before use|
+                Urea Examination Procedure
+**1.Purpose of examination:**
-==== Amendment Log1.  ====
-^Sr. No^ Date of Amendment^ Page & Clause Number of Amendment^ Amendment detail^ Reason for Amendment^
-|1 | |
-**Purpose of examination:**
 ● Urea  estimation from serum or plasma by Urease Method.
-**Responsibility and Authority:**
+**2.Responsibility and Authority:**
   * Calibration: Technician
   * Quality Control: Technician
@@ Line 22: / Line 12: @@
   * Overall Monitoring: Quality Manager
-** Sample Details:**
+**3.Sample Details:**
   * Type of Sample: Serum,Plasma
   * Type of container and additives: Plain without any additives
@@ Line 30: / Line 20: @@
   * Storage: 24 hours at 2-8° C
-**Required Equipment:**
+**4.Required Equipment:**
   * Centrifuge, Auto-Pipette, Disposable Tips, Disposable sample cups, FullyAuto Chemistry Analyzer
-**Required reagents:**
+**5.Required reagents:**
   * R1. β-NADH 1.915 g/L
   * R2.α-ketoglutaric acid 13.149 g/L
@@ Line 39: / Line 29: @@
 urease  10.000 KU/L
-**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.
-**Reagent Storage and stability**
+**7.Reagent Storage and stability**
 Unopened reagent stable at 2-8°C until expiration date.
@@ Line 49: / Line 39: @@
 contamination, turbidity, or if calibration or controls do not meet the appropriate criteria.
-**Calibration Procedure:**
+**8.Calibration Procedure:**
 **Consolidated Chemistry Calibrators(CONCC)
 Frequency:**
@@ Line 67: / Line 57: @@
   - If control results fall outside acceptable ranges,root cause analysis or recalibration may be necessary.
-**Quality control Procedure:**
+**9.Quality control Procedure:**
   * Name: Biorad Level 1 & 2
   * Frequency: As per Quality Control Procedure
@@ Line 88: / Line 78: @@
   * Check IQC results, in case outliers call residents.
-**Principle of the procedure used for examinations:**
+**10.Principle of the procedure used for examinations:**
 Urea in the sample is hydrolyzed by urease to ammonia and carbon dioxide. The second reaction, catalyzed by glutamate dehydrogenase (GLDH), converts ammonia and α-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.
@@ Line 103: / Line 93: @@
   - Put respected carrier in RSH rack
-**Performance Characteristics:**
+**11.Performance Characteristics:**
-**Linearity**:  3 to 128 mg/dL
+  * **Linearity**:  3 to 128 mg/dL
 This assay is linear across the analytical measuring interval of 3 to 128 mg/dL for serum.
 Automated Dilution Protocol:
@@ Line 110: / Line 100: @@
 Manual Dilution Procedure:
 Dilute the specimen with saline (0.85% to 0.90% NaCl). Enter the dilution factor in the Patient or Control order screen
-* **The limit of detection (LOD): 3 mg/dl
+  * **The limit of detection (LOD):** 3 mg/dl
-* The limit of quantification(LOQ): 3 mg/dL
+  * **The limit of quantification(LOQ):** 3 mg/dL
-* Unit: mg/dl**
+  * **Unit**: mg/dl
 **Normal and critical ranges:**
@@ Line 119: / Line 109: @@
 ^>18^6.0-20.0^mg/dL^
-**Laboratory Clinical interpretation:**
+**12.Laboratory Clinical interpretation:**
   * Increases in urea nitrogen may be due to increased production or decreased excretion. Urea nitrogen is useful in assessing renal function, especially with serum creatinine.
   * Urea nitrogen clearance and urea nitrogen/creatinine ratio in serum are useful clinically to assess glomerular filtration rate (GFR) and volume depletion. Urea nitrogen is used before, during and after dialysis treatment to quantify an individual’s urea clearance during a single dialysis.
-**Interference and cross reaction:**
+**13.Interference and cross reaction:**
 The Following analytes were tested up to the levels indicated at Direct Bilirubin 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 Hemoglobin up to 1,000 mg/dL
   - No interference from Intralipid up to 750 mg/dL
-**Potential source of variation:**
+**13.Potential source of variation:**
 **Turn around time (TAT):**
@@ Line 136: / Line 126: @@
   * Software backup
   * Machine raw data
-**Storage & Disposal of waste:** Follow storage & discard procedure
+  *
-**Environmental & Safety control:**
+**14.Storage & Disposal of waste:** Follow storage & discard procedure
+**15.Environmental & Safety control:**
   * Follow the universal work precautions.
   * Do not use component beyond the expiration date.
   * Do not mix materials from different kit lot numbers
-**Caution:**
+**16.Caution:**
-  * **R1** contains Methylisothiazolone and sodium azide may cause allergic reaction. Contact with acid librate toxic gas.
-**Precautions:**
+**R1** contains Methylisothiazolone and sodium azide may cause allergic reaction. Contact with acid librate toxic gas.
+**17.Precautions:**
 Wear protective gloves / protective clothing / eye protection
 Do not breathe mist / vapors / spray
@@ Line 152: / Line 145: @@
 Keep only in original container
-**Response**
+**18.Response**
 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.
 **R2** contains hydroxymethyl aminomethane and sodium azide may cause allergic reaction. Contact with acid librate toxic gas.
-**References:**
+**19References:**
-Talke H, Schubert GE.Kliniscat
+  - Talke H, Schubert GE.Kliniscat
-Teitz NW editer clinical gide for laboratory tests (3rd edi)
+  - Teitz NW editer clinical gide for laboratory tests (3rd edi)
-US department of labor,Occupational safety and health administration.
+  - US department of labor,Occupational safety and health administration.
-Burtis CA,Ashwood ER,editors,Tietz Textbook of clinical chemistry.
+  - Burtis CA,Ashwood ER,editors,Tietz Textbook of clinical chemistry.
+|**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**: Urea 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^