"I am confused over the concentration values displayed on the right side of the certificate page. You state that my sample is "b.d.", but the report also states positive values that there is protein in my test article?"
Please let us explain the certificate to you. According to the ASTM D5712 and ASTM D6499 Methods, the test lab is required to list the results in three forms as "µg/ml", "µg/g" and "µg/dm2". The two ASTM Methods were created for the glove manufacturers which needed to normalize their results so they can compare gloves with regards to the weight of the glove "µg/g" and the surface area of the glove " µg/dm2". These two values take into account the detection limit of the assay (ASTM D5712 detection limit is 8.3 µg/ml and ASTM D6499 detection limit is 0.03 µg/ml) which are both listed in the text box located in the bottom left hand corner of the certificate. So even though you had a "b.d." value, you will still have a positive value listed on the right side of the report.
"How are the values "µg/g" and "µg/dm2 " calculated on my certificate?"
This is a good question and easy to answer.
To calculate the "µg/g" on your report, the "µg/g" is derived from the detection limit of 0.03 µg/ml times the extraction volume of the sample which is then divided by the sample weight.
To calculate the "µg/dm2", the "" is derived from the detection limit of 0.03 µg/ml times the extraction volume divided by the surface are.
"What is the Turn Around Time (TAT) for my test article submission?"
The TAT for a typical test article submission is 4-5 business day upon receipt. You should receive an electronic version of the report and invoice wit in this period. If you do not receive an email from us or a hard copy sent by mail within two weeks, please contact us. If you are a customer outside of the United States and requested a hardcopy of the report, please allow 2-4 weeks for it to arrive. If you do not receive the report after this time period, please contact us
"Is the LEAP Testing Service an A2LA – 17025 Accredited laboratory? What does this mean and how does this impact my company?"
If a company decides to use an A2LA Accredited Laboratory, they are guaranteed by the accreditation body that the laboratory is assessed annually to ensure that they are following their own protocols and the protocols in the method listed on the accredited certification. The accreditation body also assesses other areas of the laboratory including:
- the qualifications, training and experience of the staff
- the right equipment - properly calibrated and maintained
- adequate quality assurance procedures
- proper sampling practices
- appropriate testing procedures
- valid test methods
- traceability of measurements to national standards
- accurate recording and reporting procedures
- suitable testing facilities
The impacts include:
- Minimize Risk - Throughout the world today, customers seek reassurance that the products, materials or services they produce or purchase meet their expectations or conform to specific requirements. This often means that the product is sent to a laboratory to determine its characteristics against a standard or a specification. For the manufacturer or supplier, choosing a technically competent laboratory minimizes the risk of producing or supplying a faulty product.
- Avoid Expensive Retesting - Testing of products and materials can be expensive and time consuming, even when they are done correctly the first time. If not done correctly, then the cost and time involved in re-testing can be even higher if the product has failed to meet specifications or expectations. not only do costs go up, but your reputation as a supplier or manufacturer can go down. You can also be held liable for any failure of your product, particularly if it involves public safety or financial loss to a client. Choosing a technically competent laboratory minimizes the chance of retesting being required.
- Enhance Your Customers’ Confidence - Confidence in your product is enhanced if clients know it has been thoroughly evaluated by an independent, competent testing facility. This is particularly so if you can demonstrate to them that the laboratory itself has been evaluated by a third party. Increasingly customers are relying on independent evidence, rather than simply accepting a supplier’s word that the product is "fit for purpose".
- Reduce Costs and Improve Acceptance of Your Goods Overseas - Through a system of international agreements (see below) technically competent, accredited laboratories receive a form of international recognition, which allows their data to be more readily accepted on overseas markets. This recognition helps to reduce costs for manufacturers and exporters that have their products or materials tested in accredited laboratories, by reducing or eliminating the need for retesting in the importing country.