TaqPath COVID-19 Fast PCR Combo Kit 2

TaqPathTM COVID-19 Fast PCR Combo Kit 2.0

INSTRUCTIONS FOR USE Multiplex realtime RTPCR test for the detection of SARS-CoV-2 RNA

Catalog Number A51606

Publication Number MAN0024913 Revision B.0

For In Vitro Diagnostic Use. For Emergency Use Authorization Only | Rx Only

Life Technologies Corporation | 6055 Sunol Blvd | Pleasanton, California 94566 USA

The customer is responsible for compliance with regulatory requirements that pertain to their procedures and uses of the instrument.

The information in this guide is subject to change without notice.

DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.

Revision history: Pub. No. MAN0024913 Revision B.0

Date 29 July 2021

Description

? Updated the following: ? Regulatory label ? "Intended Use" on page 5 ? "Required materials not supplied" on page 7 ? "Warnings and precautions" on page 9 ? "Assay limitations" on page 10 ? "Samples and controls" on page 12 ? "Sample collection, transport, and storage" on page 12 ? "Guidelines for saliva collection" on page 14 ? Chapter 7, "Conditions of authorization for labs" ? "Limit of detection (LoD)" on page 34 ? "Reactivity (Inclusivity)" on page 36 ? "Cross-reactivity" on page 37 ? "Interfering substances" on page 38 ? "Clinical evaluation" on page 41

? Added statement regarding personal data in "Set up and run the QuantStudioTM 5 RealTime PCR Instrument (96well plates)" on page 21 and "Set up and run the QuantStudioTM 7 Flex Real-Time PCR Instrument (384well plates)" on page 25.

? Added instructions for obtaining the EUO label for RUO instruments in Appendix B, "EUO label for RUO instruments".

A.0

21 May 2021

New document.

TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. TaqMan is a registered trademark of Roche Molecular Systems, Inc., used under permission and license. Windows is a registered trademark of Microsoft Corporation. Pentium is a registered trademark of Intel Corporation. Afrin is a trademark of Bayer Healthcare LLC. NeilMed and Nasogel are trademarks of NeilMed Products, Inc. Cepacol is a trademark of Reckitt Benckiser LLC. Chloraseptic is a trademark of Medtech Products Inc. Colgate is a trademark of Colgate-Palmolive Company. Crest is a trademark of The Procter & Gamble Company.

?2021 Thermo Fisher Scientific Inc. All rights reserved.

Contents

CHAPTER 1 TaqPathTM COVID-19 Fast PCR Combo Kit 2.0

product information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Contents and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Required materials not supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Assay limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 General laboratory recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Samples and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Sample collection, transport, and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

CHAPTER 2 Prepare saliva samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Guidelines for saliva collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Before you begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Prepare the samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

CHAPTER 3 Prepare RTPCR reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Guidelines for RTPCR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Prepare the RTPCR reactions (96well reaction plate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Prepare the RTPCR reactions (384well reaction plate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

CHAPTER 4 Perform RTPCR using the Applied BiosystemsTM

QuantStudioTM 5 RealTime PCR Instrument (96well block) . . . . . . . . . . . . . . . . . . . 20

Dye calibration for the QuantStudioTM 5 RealTime PCR Instrument . . . . . . . . . . . . . . . . . . . 20 Transfer the template (EDT) file for the QuantStudioTM 5 RealTime PCR Instrument

(96well block) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Set up and run the QuantStudioTM 5 RealTime PCR Instrument (96well plates) . . . . . . . . 21

TaqPathTM COVID-19 Fast PCR Combo Kit 2.0 Instructions for Use

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Contents

CHAPTER 5 Perform RT-PCR using the Applied BiosystemsTM

QuantStudioTM 7 Flex Real-Time PCR Instrument (384-well block) . . . . . . . . . . . . 24

Dye calibration for the QuantStudioTM 7 Flex Real-Time PCR Instrument . . . . . . . . . . . . . . . 24 Transfer the template (EDT) file for the QuantStudioTM 7 Flex Real-Time PCR

Instrument (384well block) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Set up and run the QuantStudioTM 7 Flex Real-Time PCR Instrument (384well plates) . . . 25

CHAPTER 6 Analysis and results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Software and instrument compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Obtain the software package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Install the assay panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Analyze the data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Interpretation of the results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

CHAPTER 7 Conditions of authorization for labs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 CHAPTER 8 Performance characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Limit of detection (LoD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Reactivity (Inclusivity) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Cross-reactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Interfering substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Clinical evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

APPENDIX A Ct cutoff values for assay targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 APPENDIX B EUO label for RUO instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 APPENDIX C Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Chemical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Biological hazard safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

APPENDIX D Documentation and support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Related documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Customer and technical support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Limited product warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

4

TaqPathTM COVID-19 Fast PCR Combo Kit 2.0 Instructions for Use

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TaqPathTM COVID-19 Fast PCR Combo Kit 2.0 product information

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Contents and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Required materials not supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Warnings and precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Assay limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 General laboratory recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Samples and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Sample collection, transport, and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Intended Use

The TaqPathTM COVID-19 Fast PCR Combo Kit 2.0 is a realtime reverse transcription polymerase chain reaction (RTPCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container under the supervision of a healthcare provider in a healthcare setting from individuals suspected of COVID-19 by their healthcare provider. 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.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all test results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type, if clinically indicated.

The TaqPathTM COVID-19 Fast PCR Combo Kit 2.0 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of realtime PCR and in vitro diagnostic procedures.

TaqPathTM COVID-19 Fast PCR Combo Kit 2.0 Instructions for Use

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