Assay Characteristics

BGM Galectin-3® (Galectin-3 Assay) is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or plasma by enzyme linked immunosorbent assay (ELISA) on a microtiter plate platform, to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF).

For full prescribing information, including warnings and precautions, please refer to the product insert.

Assay Characteristics
Method Enzyme linked immunosorbent assay (ELISA) on a microtiter plate platform
Total Incubation Time 2 hours 20 minutes
Analyte Human galectin-3
Clinical Cutoffs ≤ 17.8 ng/mL – lower risk
> 25.9 ng/mL – higher risk
Levels between 17.8 ng/mL & 25.9 ng/mL should be interpreted with caution because these values lie within the reference range
Detection Limits Limit of Detection (LoD): 1.13 ng/mL
Limit of Blank (LoB): 0.86 ng/mL
Limit of Quantitation (LoQ): 1.32 ng/mL
Cross Reactivity Galectins (1, 2, 4, 7, 8, 9 and 12) and collagens (I and III) tested:
Mean % cross reactivity at or below 0.3 %
Interferences No interference with conjugated bilirubin (up to 16.8 mg/dL), unconjugated
bilirubin (up to 40.3 mg/dL), triglycerides (up to 3000 mg/dL). Hemolyzed
specimens and those with rheumatoid factor (> 50 IU/mL) and gamma
globulins (> 2.5 g/dL) should not be used.
Measurement Range 1.4 to 94.8 ng/mL
Precision Average intra-assay CV: approximately 3.4 %
Average inter-assay CV: Approximately 8.5 %
Sample Type Human serum and EDTA plasma
Sample Number 38 samples per full plate (each sample run in duplicate)
Sample Volume 30 microliters
Sample Stability Up to 22 days @ 2 – 8 °C
Up to 24 months @ -70 °C
Kit Shelf Life 27 months from date of manufacture
Instrument Requirement Microtiter plate reader capable of reading at 450 nm
Regulatory Status FDA 510(k) cleared (k093758 November, 2010)
CLIA high complexity
Medicare Reimbursement CPT® Code: 82777
CPT® is a registered trademark of the American Medical Association.

The BGM Galectin-3® Kit is self-contained
• Microtiter plate with pre-coated antibody and break-apart wells for running partial plates
• Includes Standard concentrate (2 vials)
• Two levels of Quality Control (2 vials each)