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Hemoglobinopathy Evaluation

Item Value
Test Update Information Effective 7/18/14, all hemoglobinopathy request will be tested by HPLC and Capillary Electrophoresis. Variant hemoglobins identified may need to be confirmed by electrophoresis (acid, alkaline, and/or fast).
Clinical Questions Does my patient have thalassemia?
Approval req'd? No
Available Stat? No
Test code HBEP
Performed by China Basin Chemistry
In House Availability Set up Wednesday, reports next day unless electrophoresis required
Method Capillary Electrophoresis (on Sebia Capillarys 2 Flex Piercing) and HPLC Electrophoresis (on Bio Rad Variant II) (+/- Electrophoresis)
Collection Instructions If collecting in citrate, check the expiration date on the label of the blue top vacutainer before drawing the patient
Container type Lavender top
Amount to Collect 2 mL blood
Sample type EDTA whole blood
Preferred volume 2 mL blood
Min. Volume 1 mL blood
UCSF Rejection Criteria Samples collected in outdated blue top vacutainer.
Processing notes Do not centrifuge. Refrigerate samples
Units %
Normal range
Age Hgb F Hgb A2 Hgb A
0 to 6 days 77.0-97.9% < 1.0% 2.4-22.4%
7 to 14 days 79.6-91.4% 0.0-1.0% 8.5-19.8%
15 to 45 days 59.8-89.6% 0.0-1.5% 12.9-51.1%
46 days to < 3 months 23.9-67.2% 0.6-1.9% 35.8-77.3%
3 month to < 6 months 4.4-27.5% 1.7-2.8% 75.3-96.6%
6 months to < 9 months 1.5-27.8% 2.1-2.9% 81.1-97.6%
9 months to < 15 months 0.4-8.4% 2.2-3.2% 91.2-98.3%
15 months to < 2 years 0.1-4.9% 2.2-3.2% 94.4-98.0%
2 years to < 6 years 0.0-3.7% 2.2-3.2% 95.7-98.0%
6 years and older <1.0% 2.2-3.2% 96.7-97.8%

Pediatric reference ranges adopted from Pediatric Reference Intervals 7th edition.
Adult reference ranges adopted from vendor (Sebia) performed studies and verified by UCSF Clinical Labs by running 52 outpatient samples with a normal RBC, WBC, Hct, MCV and A1c.
Synonyms Alkali denaturation; sickle hemoglobin; HbSS; Hemoglobin A2; Hemoglobin F; fetal hemoglobin; hemoglobin E; Hemoglobin C; hemoglobin electrophoresis; Hemoglobin Bart's; sickle screen; sickledex; HbC; HbS; HbE; Hgb S; Hgb C; HGB E
Stability Refrigerated 1 week
Turn around times 1-8 days
Reflex? If variant hemoglobin is detected by HPLC or capillary electrophoresis, hemoglobin electrophoresis may need to be performed to characterize the abnormality.
Additional information Only A, A2 and F are normally present; the latter is almost completely replaced by A at age two. Hemoglobins A, A2, S, C, F, D or G, E or O, and fast hemoglobins, e.g., Hgb Bart's, are separated and quantitated.

Alkaline and/or citrate agar electrophoresis will be performed (at an additional charge) if abnormal hemoglobin(s) cannot be resolved by HPLC and capillary electrophoresis testing.

Once an abnormal hemoglobin has been confirmed, all subsequent hemoglobinopathy requests that reveal the confirmed abnormal hemoglobin will be directly reported by the capillary electrophoresis method.

HPLC and capillary electrophoresis are rapid and reproducible methods for identifying variants; however, it is possible that a rare variant may be missed. If clinical indications strongly suggest a variant hemoglobin not identified by HPLC & capillary electrophoresis, please contact the Chemistry Laboratory at 353-4820.

Iron deficiency decreases Hgb A2, and the characteristic elevation of Hgb A2 in beta-thalassemia may easily be missed.

Note: The HPLC test was developed by the Clinical Laboratories at the Medical Center at UC San Francisco. It has not been cleared or approved by the U.S. Food and Drug Administration.
CPT coding 83021; 83020
LOINC code 49322-1
LDT or Mod FDA? Yes
Last Updated 6/20/2016 2:37:40 PM
Entry Number 444
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