Folate CLIA Test CE

The Folate Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of folate in human serum or plasma (lithium heparin) using the ALTA CLIAlyzer.

Folate or Vitamin B9 is a water-soluble vitamin and one of the essential vitamins.

Folate is essential in methylation reactions and synthesis of DNA/RNA.  Thus, deficiency of folate leads to weakened cell division, and methylation reactions.  Folate status has been associated with early neoplastic processes especially in the cervix, colorectum, lung, esophagus and brain cancer.

Folate and vitamin B12 deficiency can cause macrocytic anemia and appropriate treatment depends on the differential diagnosis of the deficiency.  Determination of folate levels and accurate measurement of folate in serum or plasma is first line of approach in assessing an individual’s anemic status.

  • Individual ready-to-use cartridges
  • Combines competitive immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Sample volume: 85 μL

Range

Working range: 1.0-20 ng/mL.

Detection Limits

Limit of Detection (LOD): 1.0 ng/mL.

Precision

Intra-lot Precision

CV less than 10%

Inter-lot Precision

CV less than 12%

Recovery

Recovery rate resulted between 85% and 115%.

Linearity

Linearity greater than 0.9900 within the interval from 1.2 to 20 ng/mL.

Specificity

Cross-reactivity was evaluated by spiking zero serum samples, with 750 ng/mL cross-reactive compound. The results of this study are shown in the following table:

SubstanceCross Reaction rate
Aminopterin< 5%
Leucovorin< 5%
Methotrexate< 5%

Interference

No significant interference was detected up to the concentrations mentioned below:

SubstanceConcentration
Bilirubin≤ 20 mg/dL
Triglyceride≤ 1500 mg/dL
Total Protein≤ 10 g/dL
Rheumatoid factors≤ 1000 IU/mL

HAMA Interference 

Patient specimens containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values. Although HAMA-neutralizing agents are added, extremely high HAMA serum concentrations may occasionally affect the results

Reagents and materials provided

  1. 19-well Folate reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Liquid calibrators containing Folate at:
    1. 0 ng/mL
    2. 5 ng/mL
    3. 100 ng/mL
  3. Registration card
  4. Calibrator card
  5. Instructions for Use

Materials maybe required but not provided:

  1. Commercial controls

Materials required but not provided

  1. Pipette with disposable tip to dispense up to 100 μL.
  2. For other specific materials and disposables, refer to CLIAlyzer user manual.
  3. CLIAlyzer instrument
  4. Powderless gloves
CATALOG #PRODUCTQUANTITYSPECIMEN
L8020Folate CLIA Test60/kitS/P
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FOR EXPORT ONLY