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Detection of anti-dsDNA antibodies by computer-aided automated immunofluorescence analysis
Gabriella Lakos1, Marlene Gonzalez1, David Flaherty1
1Inova Diagnostics, Inc, San Diego, CA, USA.
Insights
The NOVA View system accurately measures anti-dsDNA antibodies using Crithidia luciliae indirect immunofluorescence test (CLIFT) technology, showing high consistency and agreement with manual readings for diagnostic immunology.
Area of Science:
- Immunology
- Diagnostic Technology
- Microscopy
Background:
- Indirect immunofluorescent tests are crucial in diagnostic immunology.
- Automated systems aim to improve the efficiency and reliability of these tests.
- Anti-dsDNA antibodies are important biomarkers, particularly in systemic lupus erythematosus (SLE).
Purpose of the Study:
- To evaluate the performance of the NOVA View system for automated anti-dsDNA antibody measurement.
- To assess the NOVA View system's accuracy using Crithidia luciliae indirect immunofluorescence test (CLIFT) technology.
- To compare automated results with manual microscopic readings.
Main Methods:
- Analytical performance was assessed for repeatability and reproducibility.
- Two hundred fifty patient samples were tested, including 50 SLE patients.
- Agreement between NOVA View CLIFT and manual microscopic reading was evaluated.
Main Results:
- NOVA View demonstrated high repeatability and reproducibility across runs and instruments.
- Agreement between NOVA View digital image reading and manual reading was 96.0%.
- Positivity rates for anti-dsDNA antibodies in SLE patients were comparable between automated and manual methods.
Conclusions:
- NOVA View CLIFT results are equivalent to manual microscopic readings in routine settings.
- The automated system offers reliability and consistency for anti-dsDNA antibody testing.
- NOVA View is a suitable alternative for automated CLIFT in clinical laboratories.
Introduction:
NOVA View is a computer aided fluorescence microscope that is used for the automated reading and interpretation of indirect immunofluorescent tests in diagnostic immunology. The objective of the present study was to evaluate the performance of the NOVA View® system for the measurement of anti-dsDNA antibodies using the Crithidia luciliae indirect immunofluorescence test (CLIFT) technology.
Methods:
Analytical performance of NOVA View CLIFT was assessed in repeatability (within run) and reproducibility (between runs and instruments) studies. Two hundred-fifty patient samples (N=200 consecutive samples and N=50 samples from systemic lupus erythematosus patients) were tested to evaluate the agreement between results generated with NOVA View CLIFT, and those obtained with manual microscopic reading of the same slides. Positivity rate in SLE was assessed on the 50 SLE samples.
Results:
The NOVA View system showed high level of repeatability and reproducibility within runs, between runs, and between instruments. Agreement of NOVA View software interpretation and digital image reading results with manual microscopic reading results was 96.0%, and the same positivity rate was obtained on SLE samples by NOVA View digital image reading as that of manual microscopic reading (36.0% vs. 38.0%, respectively).
Conclusion:
Results generated by NOVA View CLIFT were equivalent to those obtained by manual microscopic reading on a large routine sample set. NOVA View demonstrated consistency within and between runs, and between instruments. Automation of CLIFT provides reliability and is a suitable alternative for routine clinical laboratories.
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