The TaqPath COVID-19 High Throughput Combo Kit consists of assays and controls for 20,000 real-time RT-PCR tests for the detection of SARS-COV-2 RNA in preserved saliva, nasal, and nasopharyngeal samples. Clinical laboratories can run 100 to 8,000 tests in 24 hours using the Amplitude Solution, and the assay kit enables efficient ordering to address high-throughput testing needs.

Features of the TaqPath COVID-19 high-throughput kit include:
• Available with 20,000 reactions per kit for preserved saliva, nasal, and nasopharyngeal samples to help maximize specimen throughput
• Targeted specificity to 100% of currently available complete genomes for SARS-CoV-2
• Targets spike (S) protein and nucleocapsid (N) protein regions having higher specificity and exhibiting lower risk for mutation

This combo kit contains the TaqPath COVID-19 Module 1 MS2 Phage Control, TaqPath COVID-19 Module 2 Assay Kit, TaqPath COVID-19 Control, and TaqPath COVID-19 Control Dilution Buffer. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

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Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in preserved saliva, nasopharyngeal, and nasal swab specimens during the acute phase of infection. (See product label for Intended Use Statement and product information). The TaqPath COVID-19 Combo Kit is ordered as a single, high-throughput (20,000 reactions) kit and is intended to use with the Amplitude Solution.

This package is to be used in conjunction with the Amplitude High‐Throughput Consumable Package 1 Reagent kit (Cat. No. A49598).

Amplitude High‐Throughput Consumable Package 2 Assay Kit is only for use under the US Food and Drug Administration’s Emergency Use Authorization.

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