Eppendorf transparency on test methods and test specifications

As a premium supplier, we attach great importance to product quality and comply with global quality standards. Therefore, our testing procedures are validated and as part of method validation a determination of the limit of detection (LOD) is described as a regulatory requirement in the United States Pharmacopeia (USP), the guidelines of the International Conference on Harmonization (ICH), and the ISO 17025 standard. The limit of detection indicates the lowest analyte concentration at which a reliable distinction can be made between a signal from a sample containing analyte and the background noise of a sample without analyte (blank).

To increase transparency for our customers, we have listed our portfolio of test methods and test specifications in the table below for a better overview:

Test parameter Human DNA Bacterial DNA RNase DNase PCR inhibitors Sterility Endotoxins ATP
Test method Real-time PCR Real-time PCR RNA digestion RNA digestion Real-time PCR Irradiation or gassing with ethylene oxide LAL* test Bioburden determination
LOD < 2 pg < 50 fg 1.0 x10-9 Kunitz units 1.0 x10-6 Kunitz units Less than 10 targets amplifiable SAL 10-6 < 0.001 EU/mL < 5.5 x 10-12 mg

* Limulus amebocyte lysate

A major advantage distinguishing Eppendorf quality is that the tests for the listed contaminants are carried out and certified by an independent external laboratory on a lot-specific basis. This laboratory not only works in accordance with GLP guidelines, it is also certified according to ISO 9001 and the accreditation of the test laboratory according to ISO 17025 guarantees our customers that our test methods are validated for the specific application according to ISO 17025.