|
In order to carry the DLReady™ logo, luminometers must
meet several required criteria. In addition, there are preferred
criteria that Promega would like to see luminometers meet, but these
are not required for validation.
Required Criteria for the DLR™ Assay
- For 96-well luminometers, two reagent injectors with independent
liquid paths, each dispenses 100µl.
- On other luminometers, if reagent injectors are used, each
dispenses 100µl with an independent liquid path.
- Reagent injector reservoirs compatible with DLR™ reagents,
or Promega reagent vials may be used directly.
- The injector liquid paths are compatible with DLR™ reagents.
(Reagents left within the injector liquid path for 10 minutes
retain a minimum of 95% activity).
- Reagent injectors provide acceptable assay precision (relative
standard deviation of less than 5%).
- Firefly luminescence is quenched 10,000 to 100,000-fold
within 2 seconds of injecting the Stop & Glo® Reagent.
- Where reagent injection is optional, assay values obtained
using the injector agree to within 5% of assays performed manually.
- For each sample, data output minimally shows either the
luminescence values of both the firefly and Renilla
luciferases, or the ratio of the firefly luminescence divided
by the Renilla luminescence.
Preferred Criteria for DLR™ Assay
- Variable injector volumes and speeds.
- Variable measurement times and pre-measurement delay times
for each luciferase assay.
- Data output containing both luminescence measurements and
the luminescence ratio.
- The priming volume of reagent injectors of 2 to 3 times
greater than the void volume.
- Data acquisition can be achieved through a computer interface.
- Information is provided to alert users of operational requirements
specific to DLR™ Assay measurements. (Examples include using
glass reagent containers for DLR™ Reagents, and maintenance
and washing conditions for the injector liquid paths).
The above requirements have been established solely to determine
the suitability of instrumentation for use with Promega products.
Compliance with these requirements does not constitute compliance
with any requirements or standards established by the U.S. Food
and Drug Administration or any other regulatory agency, federal,
state or foreign.
|