Tests Offered

The LEAP Testing Service offers services in determining the extractable proteins in latex products.Several tests can be performed:

Payment terms are 30 days net. Click here for pricing information.

ASTM D6499 (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).

1-9 samples: $215 | 10 or greater samples: $195 | Rush: $430

ASTM D5712 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 detection reporting limit of the assay is 8.3 µg/ml.).

1-9 samples: $195 | 10 or greater samples: $175 | Rush: $390

Residual Glove Powder Analysis ASTM D6124

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.

1-9 samples: $195 | 10 or greater samples: $175 | Rush: $390

ASTM D7558 - 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).

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.

1-9 samples: $215 | 10 or greater samples: $195 | Rush: $430

Western Blot Analysis

Qualitatively assesses the molecular weight distribution of antigenic protein in latex extracts by separating the proteins with SDS-PAGE, transferring them to a nitrocellulose or PVDF membrane and then identifying the latex proteins using anti-latex antibody. 

1-7 samples: $525

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. Examples include food allergy/sensitivity ELISAs such as peanut and gluten.

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.

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