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Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics

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Considerations for Group Testing: A Practical Approach for the Clinical Laboratory.

Jun G Tan¹, Aznan Omar¹, Wendy By Lee¹

¹Department of Laboratory Medicine, Khoo Teck Puat Hospital, Singapore.

The Clinical Biochemist. Reviews

|December 21, 2020

Summary

This summary is machine-generated.

Group testing, or pooled sample testing, offers a strategy for clinical laboratories to conserve resources during shortages. This method involves pooling samples for tests like SARS-CoV-2 PCR but may reduce sensitivity and increase turnaround time.

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Area of Science:

Clinical Laboratory Science
Diagnostic Testing
Public Health

Background:

Group testing, pioneered by Robert Dorfman in 1943, is historically uncommon in clinical settings.
The COVID-19 pandemic has spurred renewed interest in pooled sample testing for clinical laboratories due to reagent shortages.

Purpose of the Study:

To propose criteria for assessing analyte suitability for pooled testing.
To outline a practical implementation approach for pooled SARS-CoV-2 PCR testing in clinical labs.

Main Methods:

Developed five criteria for evaluating analytes for pooled testing: analyte concentration difference, dilution impact on sensitivity, disease prevalence, turnaround time needs, and resource rationing imperative.
Suggested five implementation steps: determining pooling stage, protocol validation, infrastructure setup, LIS configuration, and staff training.

Main Results:

Five criteria were proposed to guide the selection of analytes for pooled testing.
A five-step practical implementation framework was outlined for clinical laboratories.

Conclusions:

Pooled testing can expand access to diagnostics during shortages but may compromise sensitivity and increase turnaround times.
The proposed criteria and implementation steps aim to facilitate the adoption of group testing in clinical laboratories for improved resource management and public health outcomes.