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Test ID: CSTC
Cystatin C, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

82994

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

As an index of glomerular filtration rate, especially in patients where serum creatinine may be misleading (eg, very obese, elderly, and malnourished patients)

 

Assessing renal function in patients suspected of having kidney disease

 

Monitoring treatment response in patients with kidney disease

Method Name A short description of the method used to perform the test

Immunoturbidimetric

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Cystatin C, S

Specimen Type Describes the specimen type needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.5 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)7 days
 Ambient 7 days
 Frozen 7 days

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Cystatin C is a low molecular weight (13,250 kD) cysteine Proteinase inhibitor that is produced by all nucleated cells and found in body fluids, including serum. Since it is formed at a constant rate and freely filtered by the kidneys, its serum concentration is inversely correlated with the glomerular filtration rate (GFR); that is, high values indicate low GFRs while lower values indicate higher GFRs, similar to creatinine.

 

The renal handling of cystatin C differs from creatinine. While both are freely filtered by glomeruli, once it is filtered, cystatin C, unlike creatinine, is reabsorbed and metabolized by proximal renal tubules. Thus, under normal conditions, cystatin C does not enter the final excreted urine to any significant degree.

 

The serum concentration of cystatin C remains unchanged with infections, inflammatory or neoplastic states, and is not affected by body mass, diet, or drugs. Thus, cystatin C may be a more reliable marker of renal function (GFR) than creatinine.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

> or =23 years: 0.57-1.29 mg/L

Reference values have not been established for patients that are <23 years of age.

Interpretation Provides information to assist in interpretation of the test results

Elevated levels of cystatin C indicate decreased glomerular filtration rate

 

Due to immaturity of renal function in neonates, cystatin C levels are higher in those <3 months of age.(1)

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Lipemic or frozen specimens, which become turbid after thawing, may interfere with the assay.

Supportive Data

In a study to evaluate cystatin C as a measure of renal function in comparison to serum creatinine, 500 patients had cystatin C measured by nephelometry and glomerular filtration rate (GFR) measured by nonradiolabeled iothalamate clearance.(2) In addition, serum creatinine was measured and the patients' medical records reviewed. The correlation of 1/cystatin C with GFR (r=0.90) was significantly superior than 1/creatinine (r=0.82, p<0.05) with GFR. The superior correlation of 1/cystatin C with GFR was observed in the various clinical subgroups of patients studied (ie, subjects with no suspected renal disease, renal transplant patients, recipients of some other transplant, patients with glomerular disease, and patients with non-glomerular renal disease). Using the lower 5th percentile age-adjusted normal values for iothalamate clearance, receiver operator characteristic curves were generated. The area under the curve for 1/cystatin C was significantly greater than for 1/creatinine. These results indicate that cystatin C may be superior to serum creatinine for the assessment of GFR in a wide spectrum of patients-both those with renal disease and those without renal disease. Others have similarly found that cystatin C correlates better than serum creatinine for assessment of GFR.(3)

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Finney H, Newman DJ, Thakkar H, et al: Reference ranges for the plasma cystatin C and creatinine measurements in premature infants, neonates, and older children. Arch Dis Child 2000 Jan;82(1):71-75

2. Buehrig CK, Larson TS, Bergert JH, et al: Cystatin C is superior to serum creatinine for the assessment of renal function. J Am Soc Nephrol 2001;12:194A

3. Grubb AO: Cystatin C - properties and use as a diagnostic marker. Adv Clin Chem 2000;35:63-99

4. Coll E, Botey A, Alvarez L, et al: Serum cystatin C as a new marker for noninvasive estimation of glomerular filtration rate and as a marker for early renal impairment. Am J Kidney Dis 2000 Jul;36(1):29-34

Method Description Describes how the test is performed and provides a method-specific reference

Serum or plasma sample from human is mixed with Gentian Cystatin C immunoparticles. Cystatin C from the sample and anti cystatin C from the immunoparticles aggregates. The complex particles created absorb light, and by turbidimetry the absorption is related to cystatin C concentration via interpolation on an established standard calibration curve.

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Saturday; 3 p.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

82610

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
CSTCCystatin C, S33863-2