Last Modified:
5/17/2019 2:34:27 PM
Medicare Medical Necessity Restrictions May Apply
Medical Necessity Documentation:
Client Notes:
Patient Preparation:
Overnight fasting is preferred
Specimen Requirements:
2.0 mL Serum from a Red Top Tube in a Plastic Vial
Collection Instructions:
Do not submit specimens that have been heat treated. Do not submit the sample in a glass tube.
Do not collect in a Serum Separator Tube (SST or PST)
Minimum Volume:
0.3 mL Serum
Transport & Storage: Temperature/Stability:
21 days Frozen
Rejection Criteria:
Hemolysis • Lipemia • Heat treated • Specimens containing visible particular matter
Reference Range:
Deficient: <100 ng/mL
Normal: >or = 100 ng/mL
Critical Ranges:
Test Comments:
Methodology:
Enzyme Linked Immunosorbent Immunoassay (ELISA)
Clinical Significance:
The deficiency of Mannose-Binding Lectin (MBL) can be used to aid in the determination of susceptibility to infection in conjunction with clinical findings and other laboratory tests. Mannan- Binding Lectin (MBL) is a serum collection (c-type lectin) and is considered an important component of the innate immune system. Clinical studies have used 50 or 100 ng/mL to define severe MBL deficiency. MBL is also know to activate the classical complement pathway through its binding to serine proteases MASP-2 and MASP-1. MBL deficiency has been associated with recurrent infections in children 6 -17 months of age, during the time when the adaptive immune system (IgG production) is not fully mature.
Documentation:
This test was performed using a kit that has not been approved or cleared by the FDA. The analytical performance characteristics of this test have been determined by Quest Diagnostics Nichols Institute, San Juan Capistrano. This test should not be used for diagnosis without confirmation by other medically established means.
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
5 to 12 days
Days Performed:
Thursday
Sites Performed:
Quest - Chantilly to San Juan Capistrano
PHL Test Code:
MBL
EPIC Test Code:
LAB2718
Send Out Test Code:
16039
Alternate Test Names:
Mannose Binding Lec; MBL
Included Tests:
CPT Coding:
83520
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