Clinical Validation of an Alternative Specimen Collection Kit for SARS-CoV-2 Testing at Fox Chase Cancer Center

Area of Science:

• Biotechnology
• Medical Diagnostics
• Public Health

Background:

• COVID-19 pandemic highlighted vulnerabilities in global supply chains for essential medical components.
• Disruptions affected the availability of specimen collection kits for SARS-CoV-2 detection.
• Plastic injection molding presents a cost-effective, high-volume production method for respiratory sampling swabs.

Purpose of the Study:

• To validate locally produced virus transport medium and novel injection molded swabs for SARS-CoV-2 detection.
• To compare the performance of these novel components against standard counterparts.
• To assess the stability and reliability of locally sourced materials for diagnostic testing.

Main Methods:

• Validation of locally produced virus transport medium and injection molded swabs.
• Reverse-transcription quantitative polymerase chain reaction (RT-qPCR) for SARS-CoV-2 detection.
• Comparative analysis using viral reference material and clinical patient samples.

Main Results:

• No significant clinical differences were observed between injection molded swabs and standard flocked swabs.
• Both commercial and in-house virus transport media demonstrated stable SARS-CoV-2 detection results for over 40 days.
• Patient sample testing showed comparable results between different media and swab types.

Conclusions:

• Locally manufactured collection kit components provide reliable SARS-CoV-2 detection.
• This approach enhances flexibility and resilience in diagnostic supply chains.
• Offers a sustainable solution to mitigate future shortages of testing materials.