The Amplitude High‐Throughput Consumable Package 1 Reagent Kit contains reagents for 20,000 reactions. This package allows for streamlined ordering of reagents to efficiently address high-throughput testing needs. When used on the Amplitude System, clinical laboratories can process from 100 to 8,000 specimens in 24 hours.

Features of the high-throughput reagent kit include:
• Complete set of reagents for 20,000 reactions using the Amplitude Solution
• Allows for simplified ordering for high-throughput testing
• Designed specifically for use with Amplitude Solution systems

Testing with the COVID-19 High Throughput Solution is designed and intended (i) for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures (ii)  for use under the Food and Drug Administration’s Emergency Use Authorization. Testing is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.

This package is to be used in conjunction with the Amplitude High‐Throughput Consumable Package 2 Assay.

The ordering of Amplitude Solution reagents and consumables is managed by your Sales Representative in accordance with your laboratory Supply Agreement.