Tests Offered

The LEAP Testing Service offers services in determining the extractable proteins in latex products. There are several tests that can be performed:

Payment terms are 30 days net.

ASTM D6499-12 (Inhibition ELISA)*

This assay uses an Inhibition ELISA to quantitate antigenic latex protein in product extracts. In an Inhibition ELISA, soluble antigens in the extract compete for binding to specific anti-latex antibodies and block antibody binding to latex antigen immobilized on the surface of the assay plate (the detection limit of the assay is 0.03 µg/ml).

Pricing:
Cost per Sample - $205.00
Cost per Sample (RUSH) - $410.00

ASTM D5712-10 Lowry with Precipitation*

Quantitatively measures the level of extractable proteins in latex products using a precipitation step to decrease the levels of interfering substances (5712-10 detection reporting limit of the assay is 8.3 µg/ml.).

Pricing:
Cost per Sample - $185.00
Cost per Sample (RUSH) - $370

 

Residual Glove Powder Analysis ASTM D6124-11

Quantitatively measures the amount of powder on the surface of gloves. The assay is performed by washing the glove with dH2O. The wash is then filtered through a glass fiber filter. The change in weight of the filter reflects the amount of powder present on the glove. Results are given in terms of mg powder/glove. The ASTM has set limits for the amount of powder on the surface of gloves. These standards are: <1mg/glove for "Powder Free" gloves, <10mg/glove fore Examination gloves, and <15mg/glove for Surgical gloves.

Pricing:
Cost per Sample - $185.00
Cost per Sample (RUSH) - $370

ASTM D7558-09 - Chemical Sensitivity*

The chemical sensitivity assay was developed to quantify residual chemicals (vulcanization accelerators) used in the manufacturing of latex devises. Individuals can develop allergic contact dermatitis while being exposed to these residual chemicals. Monitoring the residual chemicals can give customers useful data to lower the amount of expose to these chemicals in their final products (the detection limit of the assay is 7.5 µg/ml).

Pricing:
Cost per Sample - $185.00
Cost per Sample (RUSH) - $370

Guayule Latex ELISA

This assay uses an Inhibition ELISA to quantitate antigenic Guayule latex protein in product extracts. In an Inhibition ELISA, soluble antigens in the extract compete for binding to specific anti-latex antibodies and block antibody binding to latex antigen immobilized on the surface of the assay plate.

Pricing:
Cost per Sample - $205.00
Cost per Sample (RUSH) - $410

Latex in Air Analysis ELISA

This assay applies the D6499-12 assay in conjunction with air monitoring techniques. Suspect Latex contaminated air is filtered through air monitoring cassettes which is then is extracted from the filters and then analyzed utilizing the D6499-12 assay.

Pricing:
Cost per Sample - $205.00
Cost per Sample (RUSH) - $410.00

Specialized Studies

Provides customers with specialized studies using state of the art research techniques. Studies may include: development of new tests, specialized product testing, or research protocols under confidentiality agreements. Study protocols and costs would be outlined in a proposal after the study goals have been fully evaluated.

Basic Science

Provides customers with tissue culture, molecular biology, microscopy, western blotting, SDS-PAGE, and others areas of basic science applications for medical device applications.

* A2LA accredited assays.