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Rapid Molecular Detection and Differentiation of Influenza Viruses A and B

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Published on: January 30, 2017

[Performance Evaluation of "BinaxNOW™ Streptococcus pneumoniae" Using Alere™ Reader].

Tomoko Ohno¹, Hiroyuki Suematsu¹, Akiko Nakamura¹

¹Division of Microbiological Laboratory, Department of Infection Control and Prevention, Aichi Medical University Hospital, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.

Rinsho Biseibutsu Jinsoku Shindan Kenkyukai Shi = JARMAM : Journal of the Association for Rapid Method and Automation in Microbiology

|December 21, 2019

Summary

The Alere™ reader offers objective and accurate results for detecting Streptococcus pneumoniae antigen, improving upon subjective visual interpretations of immunochromatographic tests. This automated reader enhances laboratory workflow and provides earlier detection of pneumococcal infections.

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Area of Science:

Clinical Microbiology
Diagnostic Assays
Infectious Diseases

Background:

Streptococcus pneumoniae is a primary cause of community-acquired pneumonia.
Immunochromatographic assays are common for detecting pneumococcal antigen but often rely on visual interpretation.
Visual interpretation of these tests can be subjective and vary between individuals.

Purpose of the Study:

To evaluate the performance of the Alere™ reader for interpreting the BinaxNOW™ Streptococcus pneumoniae test.
To compare the reader's objectivity and accuracy against visual interpretation.
To assess the reader's utility in streamlining laboratory workflow for pneumococcal antigen detection.

Main Methods:

Performance evaluation using urine samples from 100 patients undergoing pneumococcal urine antigen testing.
Comparison of results obtained from visual interpretation versus the Alere™ reader.
Investigation of discrepant results, including sample pre-treatment (centrifugation, ultrafiltration).
A questionnaire-based study to assess inter-observer variability in visual interpretation.

Main Results:

The Alere™ reader demonstrated higher sensitivity, identifying 19 positive results compared to 14 visually positive results.
All visually positive samples were correctly identified by the reader.
Discrepant results were resolved after sample concentration, with the reader showing positive results earlier than visual interpretation.
Significant inter-observer variability was observed in visual interpretation, particularly with low-level positive results.

Conclusions:

The Alere™ reader provides objective and accurate interpretation of the BinaxNOW™ Streptococcus pneumoniae test, overcoming limitations of visual assessment.
The reader can detect positive results earlier and reduce inter-observer variability, making it a valuable tool in clinical settings.
Implementation of the reader can enhance diagnostic efficiency and reliability in identifying pneumococcal infections.