Test ID: FRAG
Osmotic Fragility, Erythrocytes
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Suspected hereditary spherocytic hemolytic anemia
Confirming or detecting mild spherocytosis
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| FRAGO | Osmotic Fragility | No | Yes |
| SCTRL | Sex of Control Vial | No | Yes |
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Osmotic Lysis
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
RBC Fragility, Erythrocytes
Red Cell Fragility
Specimen Type Describes the specimen type needed for testing
Whole Blood EDTA
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.
See Recommendations for Collection of Control Specimens for FRAG, HSEP, and HAEVP in Special Instructions.
Specimens must arrive in the testing laboratory within 96 hours of draw.
A whole blood EDTA specimen and a control specimen are required.
Patient:
Container/Tube: Lavender top (EDTA)
Specimen Volume: 5 mL
Collection Instructions:
1. Immediately refrigerate specimen after draw.
2. Do not transfer blood to other containers.
3. Rubber band patient specimen and control vial together.
Additional Information: Patient's age and sex are required.
Forms: If not ordering electronically, please submit a Hematopathology/Molecular Oncology Request Form (Supply T241) with the specimen.
Normal Control:
Specimen Type: Whole blood
Container/Tube: Lavender top (EDTA)
Specimen Volume: 5 mL
Collection Instructions:
1. Draw a control specimen at the same time from a normal, unrelated, non-smoking individual.
2. Clearly write normal control on outermost label and also indicate sex of control on same label.
3. Immediately refrigerate specimen after draw.
4. Do not transfer blood to other containers.
5. Rubber band patient specimen and control vial together.
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.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| 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 Type | Temperature | Time |
|---|---|---|
| Control | Refrigerated | 4 days |
| Whole Blood EDTA | Refrigerated | 4 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Spherocytes are osmotically fragile cells that rupture more easily in a hypotonic solution than do normal RBCs. Because they have a low surface area: volume ratio, they lyse at a higher osmolarity than do normal discocyte RBCs. Cells that have a larger surface area: volume ratio, such as target cells or hypochromic cells are more resistant to lysing. After incubation, an increase in hemolysis is seen in hereditary spherocytosis.
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.
0.50 g/dL NaCl (unincubated)
Males: 0.0-47.8% hemolysis
Females: 0.0-31.1% hemolysis
0.60 g/dL NaCl (incubated)
Males: 18.7-67.4% hemolysis
Females: 10.9-65.5% hemolysis
0.65 g/dL NaCl (incubated)
Males: 4.4-36.6% hemolysis
Females: 0.2-39.3% hemolysis
0.75 g/dL NaCl (incubated)
Males: 0.8-9.1% hemolysis
Females: 0.0-10.9% hemolysis
Interpretation Provides information to assist in interpretation of the test results
Increased lysis in 3 or more concentrations of sodium chloride indicates increased red cell fragility.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Infrequently, other hemolytic disorders may also be associated with positive results, as in patients with congenital nonspherocytic hemolytic anemia due to glucose-6-phosphate dehydrogenase or pyruvate kinase deficiency.
Patients with an immunohemolytic anemia, or who have recently received a blood transfusion may also have increased RBC lysis.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Palek J, Jarolin P: Hereditary spherocytosis. In Hematology. Fourth edition. Edited by WJ Williams, E Beutler, AJ Erslev, MA Lichtman. New York, McGraw-Hill Book Company, 1990, pp 558-569
Method Description Describes how the test is performed and provides a method-specific reference
Specimens for erythrocyte osmotic fragility tests are anticoagulated with EDTA. Osmotic lysis is performed using sodium chloride (NaCl) solution, 0.50 g/dL. An incubated fragility test is performed following 24-hour incubation at 37 degrees C at the following NaCl concentrations: 0.60, 0.65, and 0.75 g/dL. Results are reported and interpreted.(Larson CJ, Scheidt R, Fairbanks VF: The osmotic fragility test for hereditary spherocytosis: use of EDTA-anticoagulated blood stored at 4 degrees C for up to 96 hours. Am Soc Clin Pathol Meeting Abstract, 1988; Larson CJ, Scheidt R, Fairbanks VF: The osmotic fragility test for hereditary spherocytosis: objective criteria for test interpretation. Am Soc Clin Pathol Meeting Abstract, 1988)
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; 1 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.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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.
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.
85557
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 ID | Reporting Name | LOINC Code |
|---|---|---|
| 9064 | Osmotic Fragility, RBC | 34964-7 |
| SCTRL | Sex of Control Vial | N/A |
| 3306 | Osmotic Fragility, 0.50 g/dL NaCl | 23915-2 |
| 3307 | Osmotic Fragility, 0.60 g/dL NaCl | 23917-8 |
| 3308 | Osmotic Fragility, 0.65 g/dL NaCl | 23919-4 |
| 3309 | Osmotic Fragility, 0.75 g/dL NaCl | 30543-3 |
| 3310 | Osmotic Fragility Comment | In Process |
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