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ADAMTS13 Inhibitor

Justification

Machaon provides the fastest ADAMTS13 activity and inhibitor testing available in the US. Rapid diagnosis and administration of correct treatment is paramount for TTP and aHUS. This test is diagnostic for Thrombotic Thrombocytopenic Purpura (TTP) when ADAMTS13 Activity levels are below 10%. Consider other Thrombotic Microangiopathies (TMAs), such as atypical Hemolytic Uremic Syndrome (aHUS), for ADAMTS13 Activity levels above 10%.

STAT: < 24 hours (7 days a week)

ELISA

Draw Tube: Blue Top

Sample Type: Citrated Plasma

DRAW KITS AVAILABLE

Specimen Requirements

Sample Type Volume Required Minimum Volume Stability
PREFERRED Citrated Plasma 1mL 0.5mL Room Temp.: 7 days
Refrigerated: 7 days
Frozen (-20C): 2 weeks
Frozen (-80C): 6 months
ALTERNATIVE - - - -
REJECTION CRITERIA Thawed in transit if shipped frozen, refrozen, clotted sample
SPECIAL INSTRUCTIONS Must be ordered with ADAMTS13 ActivityMark Saturday delivery on FedEx airbill if shipping on a Friday.

General Information

METHODOLOGY ELISA
STAT TAT < 24 hours (7 days a week)
STAT TAT Performance > 95% of results released in 15.5 hours 7 days a week
ROUTINE TAT < 24 hours (M-F)
ALTERNATIVE NAMES VWF-Cleaving Protease Inhibitor, ADAMTS-13, cTTP diagnostic test, TTP diagnostic test
DESCRIPTION Chromogenic ELISA for the qualitative detection of ADAMTS13 activity inhibition. ADAMTS13 is an enzyme that specifically cleaves large von Willebrand Factor multimers, which induce platelet thrombus formation under high shear stress. If the activity of ADAMTS13 is lowered for some reason, unusually large VWF multimers may accumulate.
LIMITATIONS Samples containing EDTA cannot be used because EDTA is a strong inhibitor of ADAMTS13 function. Hemolysis does not affect assay performance with samples containing up to 200mg/dL of hemoglobin. Lipemia does not affect assay performance with samples containing up to 300mg/dL of lipids. Icterus does not affect assay performance with samples containing up to 15mg/dL of bilirubin (both conjugated and unconjugated).
NORMAL RANGE Negative
ASSOCIATED TESTING ADAMTS13 Gene Sequencing; aHUS Genetic Panel; TMA-Complete Genetic Panel
REFERENCES

1. Bethany, G et al. ADAMTS-13 activity and autoantibodies classes and subclasses as prognostic predictors in acquired thrombotic thrombocytopenic purpura. J Thromb Haemost. 2012;10:1556-1565.
2. Peyvandi, F et al. ADAMTS13 and anti-ADAMTS13 antibodies as markers for recurrence of acquired thrombotic thrombocytopenic purpura during remission. Haematologica. 2008;93(2):232-239.
3. Rieger, M et al. ADAMTS13 autoantibodies in patients with thrombotic microangiopathies and other immunomediated diseases. Blood. 2005;106(4):1262-1267.
SAMPLE REPORT Upon request
NEW YORK STATE APPROVED Yes

Test Codes

ORDER CODE P3337
CPT CODE 85397, 85335
LOINC CODE 53622-7, 34590-0