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**1.Purpose of examination: | **1.Purpose of examination: | ||
● Urea estimation from serum or plasma by Urease Method. | ● Urea estimation from serum or plasma by Urease Method. | ||
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**11.Performance Characteristics: | **11.Performance Characteristics: | ||
- | **Linearity**: | + | * **Linearity**: |
This assay is linear across the analytical measuring interval of 3 to 128 mg/dL for serum. | This assay is linear across the analytical measuring interval of 3 to 128 mg/dL for serum. | ||
Automated Dilution Protocol: | Automated Dilution Protocol: | ||
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Manual Dilution Procedure: | 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 | 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): | + | |
- | **Unit**: mg/dl | + | |
**Normal and critical ranges:** | **Normal and critical ranges:** | ||
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* 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. | * 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/ | * Urea nitrogen clearance and urea nitrogen/ | ||
- | **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: | 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 Bilirubin up to 30 mg/dL | ||
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* Software backup | * Software backup | ||
* Machine raw data | * Machine raw data | ||
+ | * | ||
**14.Storage & Disposal of waste:** Follow storage & discard procedure | **14.Storage & Disposal of waste:** Follow storage & discard procedure | ||
- | *15.*Environmental & Safety control:** | + | |
+ | **15.Environmental & Safety control:** | ||
* Follow the universal work precautions. | * Follow the universal work precautions. | ||
* Do not use component beyond the expiration date. | * Do not use component beyond the expiration date. | ||
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**19References: | **19References: | ||
- | Talke H, Schubert GE.Kliniscat | + | - Talke H, Schubert GE.Kliniscat |
- | Teitz NW editer clinical gide for laboratory tests (3rd edi) | + | |
- | US department of labor, | + | |
- | Burtis CA,Ashwood ER, | + | |
+ | |**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**: Urea 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, |