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+ | |[[clinical_biochemistry_section|Home]]|[[clinical_biochemistry|]]|[[examination_procedures|]]| | ||
- | + | Total Protein Examination Procedure | |
**1.Purpose of examination: | **1.Purpose of examination: | ||
Total Protein estimation from serum or plasma by Biuret Method. | Total Protein estimation from serum or plasma by Biuret Method. | ||
Line 14: | Line 14: | ||
* 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 | ||
- | * Patient Preparation: | + | * Patient Preparation: |
* 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 | ||
Line 92: | Line 92: | ||
- Put respected carrier in RSH rack. | - Put respected carrier in RSH rack. | ||
- | **Performance Characteristics: | + | **13.Performance Characteristics: |
- | **Linearity: | + | |
- | **The limit of detection (LOD):** 0.2 g/dL | + | |
- | **The limit of quantification(LOQ)**: | + | |
- | **Unit:** g/dL | + | |
**Normal and critical ranges:** | **Normal and critical ranges:** | ||
- | ^Protein total^0-7 days^4.4-7.6^g/ | + | **Protein total** |
+ | ^0-7 days^4.4-7.6^g/dL^ | ||
+ | ^<1 y^5.1-7.3^g/ | ||
+ | ^1-2 y^5.6-7.5^g/ | ||
+ | ^>2 y^6.0-8.0^g/dL^ | ||
- | <1 y | ||
- | 5.1-7.3 | ||
- | g/dL | ||
+ | **14.Laboratory Clinical interpretation: | ||
+ | * Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving liver, kidney, lymph nodes, spleen, or bone marrow. | ||
+ | * High protein levels may be observed in cases of severe dehydration and disease states such as multiple myeloma. Changes in the proportions of the plasma proteins may occur in one or several of the protein fractions and often without alterations in the quantity of the total protein. | ||
+ | * Low protein levels may be caused by such conditions as nephrotic syndrome, extensive bleeding, sprue (deficient protein absorption), | ||
+ | * High or low total protein may lead one to suspect pathologic variation of individual proteins and may indicate additional testing including serum protein electrophoresis, | ||
- | 1-2 y | + | **15.Interference and cross reaction:** |
- | 5.6-7.5 | + | 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: |
- | g/dL | + | |
+ | * No interference from Bilirubin up to30 mg/dL) | ||
+ | * No interference fromHemoglobin up to 250 mg/dL | ||
+ | * No interference from Human triglyceride up to 1000 mg/dl | ||
- | >2 y | ||
- | 6.0-8.0 | ||
- | g/dL | ||
+ | **16.Potential source of variation: | ||
+ | **17.Turn around time (TAT):** | ||
- | | + | **Routine:** 6.0 hours |
- | ● Measurements of total protein are used in the diagnosis and | + | **Urgent:** 2.0 hours |
- | treatment of a variety of diseases involving liver, kidney, lymph | + | |
- | nodes, spleen, or bone marrow. | + | |
- | High protein levels may be observed in cases of severe dehydration and disease states such as multiple myeloma. Changes in the proportions of the plasma proteins may occur in one or several of the protein fractions and often without alterations in the quantity of the total protein. | + | |
- | Low protein levels may be caused by such conditions as nephrotic syndrome, extensive bleeding, sprue (deficient protein absorption), | + | |
- | High or low total protein may lead one to suspect pathologic variation of individual proteins and may indicate additional testing including serum protein electrophoresis, | + | |
+ | **18.Recording of observation: | ||
+ | * Software backup | ||
+ | * Machine raw data | ||
+ | **19.Storage & Disposal of waste**: Follow storage & discard procedure | ||
+ | **20.Environmental & Safety control:** | ||
+ | * For in vitro diagnostic use | ||
+ | * Do not use component before the expiration date | ||
+ | * Do not mix material from different kit lot number. | ||
+ | **21.References: | ||
+ | - US department of labor, | ||
+ | - US department of health and human services. Biosafety in MIcrobiological and biomedical | ||
+ | - World health organization. Biosafety manual,3rd edition. | ||
+ | - Burtis CA,Ashwood ER, | ||
+ | - Kaplan LA,Pesce AJ editors. Clinical Chemistry Theory, Analysis, and Correlation, | ||
- | | + | |**Printed copy of this document is considered uncontrolled.** It should be compared with controlled electronic copy before use| |
- | The Following analytes were tested up to the levels indicated at Direct Bilirubin concentrations | + | |
- | + | ||
- | No interference from Bilirubin up to30 mg/dL) | + | |
- | No interference fromHemoglobin up to 250 mg/dL | + | |
- | No interference from Human triglyceride up to 1000 mg/dl | + | |
- | Potential source | + | ^Name of Laboratory |
- | Turn around time (TAT): | + | ^Document No.1^**Document Name**: Total Protein Examination Procedure^**Unique ID**:LSSTH /BIOCHEM/ SOP-5^^ |
- | Routine: 6.0 hours | + | ^Issue No. : 01^Issue Date :30/ |
- | Urgent: 2.0 hours | + | ^Amend No.^ Amend Date ^Prepared by: Section Incharge^Approved & Issued by: HOD,Biochemistry^ |
- | | + | |
- | Software backup | + | |
- | Machine raw data | + | |
- | Storage & Disposal of waste: Follow storage & discard procedure | + | |
- | Environmental & Safety control: | + | |
- | For in vitro diagnostic use | + | |
- | Do not use component before the expiration date | + | |
- | Do not mix material from different kit lot number. | + | |
- | References: | + | |
- | US department of labor,Occupational safety and health administration. | + | |
- | US department of health and human services. Biosafety in MIcrobiological and biomedical | + | |
- | World health organization. Biosafety manual,3rd edition. | + | |
- | | + | |
- | | + | |