Test Type: Kit Based - Blood Draw

Overview:

PURPOSE: Screening procedure to determine existing reaction with components of dental and orthopedic restoratives, irrespective of initiating source; facilitate selection of least offensive restorative products for individual patients.

TEST BASIS: Passive antibody detection by precipitin method, present at or above a relevant threshold to eliminate noise effects from casual contact.

TARGET ANTIBODY CLASSES: IgG, IgM

ANTIGENS: 94 chemical groups and families of compounds.

REQUESTED SPECIMEN: 2-3ml separated serum; plasma can be used if necessary.

RELIABILITY: >95% on sequential multiple specimens.

PRECISION: >97% on multiple aliquots from the same specimen.

DETERMINATION OF PRODUCT SUITABILITY: Based upon material components in dissociable, ionizable, releasable, bio-available, or bio-convertible form.

REPORTING: Positive or negative determination for 94 basic chemical groups and families of compounds; correlation of findings with more than 17,204 dental restorative trade name products in 37 application categories, and more than 10,427 orthopedic restorative trade name products in 34 application categories, arranged both categorically and alphabetically.

CONTRAINDICATIONS:

  • Severe immune incompetence which precludes the normal generation of antibody
  • Heavy long-term immuno-suppression by medication or otherwise
  • Universal reactor status wherein reactions do not involve normal antigen processing cascades and antibody generation
  • Restricted usefulness in children without a mature immune record
  • Hyperactive non-specific immunoglobulin generation

FALSE POSITIVES:

  • Crossover between haptens (especially metals)
  • Hyper-reactive serum proteins lacking specificity
  • Long-term specimen holding without adequate refrigeration/freezing
  • Microbial overgrowth

FALSE NEGATIVES:

  • Antibody titers below detection limits
  • The onset of high tolerance to immunogens
  • Failure to process antigen and induce systemic antibody

 

Collection Details:

Patient Preparation:

Follow the link below for Patient Test Prep Instructions:

ELISA/ACT CMRT Instructions