SpectraTest

Fluorescence and Absorbance Reader Validation

applications

• Absorbance validation
• Fluorescence validation
• Automated testing
• NIST traceability
• Recertification

SpectraMax® absorbance and multi-detection microplate readers and Gemini fluorescence spectrophotometers are designed to provide consistent performance for many years, but to fulfill your regulatory requirements, instrument performance should be validated and documented regularly. The SpectraTest FL1 and SpectraTest ABS1 validation packages provide automated, comprehensive and traceable validation of optical performance, and automatic verification of your SpectraMax, VersaMax, Gemini EM and Gemini XPS.

SpectraTest FL1 fluorescence validation package tests

Qualify the fluorescence performance of the SpectraMax M2, SpectraMax M5, Gemini EM and Gemini XPS readers, by testing the specifications that are absolutely critical to compliance. Twelve different automated tests are provided:

Fluorescence lower limit of detection (LLD) Excitation wavelength accuracy Emission wavelength accuracy Excitation wavelength precision Emission wavelength precision PMT matching (high vs. medium PMT settings)

Top-to-bottom bias Kinetic noise (low signal) Kinetic noise (high signal) Well-to-well reproducibility RFU scale ratio Relative fluorescence unit (RFU) linearity

SpectraTest ABS1 absorbance validation package tests

Qualify the absorbance performance of the SpectraMax M2, SpectraMax M5, Plus384, Plus, 190, 340PC, 340PC384 and VersaMax readers by testing the specifications that are absolutely critical to compliance. Eight different automated tests are provided:

Absorbance accuracy (linearity) Precision (reproducibility) Stray light Wavelength accuracy

Wavelength repeatability Ultimate dark (0% Transmittance) Optical alignment Baseline noise

automated for ease of use

All test measurements and calculations are handled automatically by the software protocols. Should any of the measurement parameters fall outside defined limits, a test failure is reported with the suspect parameters identified.

NIST traceability

SpectraTest ABS1
Each filter is individually tested across all eight channels of the plate. Calibration of the plate's filter standards is accomplished through the use of an instrument calibrated with primary NIST standards.

SpectraTest FL1
A combination of fluorescence reference material and NIST-traceable didymium glass exhibits calibrated wavelength peaks used for wavelength accuracy testing.

recertification service

So that confidence in the standards is maintained, Molecular Devices recommends having your validation plate recertified at one year intervals. Validation plates sent to Molecular Devices for recertification are disassembled, cleaned and calibrated, then returned with a new certificate of calibration.

additional validation tools

In addition to the SpectraTest ABS1 and FL1 validation plates, IQ/OQ/PQ validation, SoftMax® Pro software validation and FDA 21 CFR Part 11 compliance tools are available.