Table of Contents

1. Introduction
2. Understanding 2019-nCoV
3. 2019-ncov test kit Overview
   1. Test Types
   2. Sensitivity and Specificity
   3. Limitations
4. Company Solutions
   1. Roche Diagnostics
   2. Abbott Laboratories
   3. Thermo Fisher Scientific
5. References

Introduction

The emergence of the novel coronavirus SARS-CoV-2 in 2019 necessitated the rapid development of testing methodologies to diagnose and control the spread of COVID-19. The 2019-nCoV test kit, commonly known as a COVID-19 test kit, plays a critical role in identifying infections caused by the virus.

Understanding 2019-nCoV

SARS-CoV-2, commonly referred to as 2019-nCoV, is a beta-coronavirus responsible for the acute respiratory disease COVID-19. The virus is part of a large family of coronaviruses that can lead to illnesses ranging from the common cold to more severe diseases.

2019-nCoV Test Kit Overview

Test Types

There are primarily two categories of 2019-nCoV test kits:

• Reverse Transcription Polymerase Chain Reaction (RT-PCR) tests
• Antigen tests

RT-PCR tests are considered the gold standard due to their high sensitivity and accuracy, though results typically take several hours. Antigen tests, while less sensitive, are faster and can deliver results in under an hour.

Sensitivity and Specificity

Sensitivity denotes a test's ability to correctly identify those with the virus (true positive rate), while specificity refers to correctly identifying those without it (true negative rate).

• RT-PCR tests have a sensitivity of approximately 95% and specificity of 98%.
• Antigen tests have a sensitivity of around 85% and specificity of 97%.

Limitations

2019-nCoV test kits can face limitations such as false negatives, especially in the early stages of infection when viral loads are low, and false positives, though these are less common. Environmental factors and sample collection techniques also influence test accuracy.

Company Solutions

Roche Diagnostics

Roche offers the cobas® SARS-CoV-2 test, which is an RT-PCR test providing results typically within 4 hours, and has an analytical sensitivity of 100 copies/mL.

Abbott Laboratories

Abbott has developed the BinaxNOW™ COVID-19 Ag Card, a rapid antigen test with results in 15 minutes, showing a sensitivity of 84.6% and specificity of 98.5% according to clinical studies.

Thermo Fisher Scientific

Thermo Fisher provides the TaqPath™ COVID-19 Combo Kit, an RT-PCR test with a detection limit of 10 genomic copies per reaction, offering reliable results in under 3 hours.

References

1. Johns Hopkins University. Understanding COVID-19 Testing. 2020.
2. Centers for Disease Control and Prevention (CDC). COVID-19 Diagnostic Testing. 2021.
3. Food and Drug Administration (FDA). In Vitro Diagnostics EUAs. 2021.