Simplexa®
COVID-19 Direct Kit

Enabling Swift Action Against the COVID-19 Pandemic

KIT for Infectious Diseases

Overview

Background

Coronaviruses (CoV) are a large family of viruses that cause illnesses ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV).1 The current outbreak of coronavirus disease was first reported from Wuhan, China in December 2019. After cases were identified in several countries, a global health emergency was declared with over 167,000 cases and thousands of deaths.2

Since its discovery in late 2019 in China, things have escalated rapidly in the U.S. On January 21, 2020 the first COVID-19 case was confirmed in Washington state and only seven weeks later, the U.S. declared a National Emergency with over 4,000 confirmed cases.1 Risk factors for severe illness are not yet clear, although older patients and those with chronic medical conditions may be at higher risk.1 Testing methods for the SARS-CoV-2 are still developing and are highly complex. Current molecular methods involve significant specimen handling time and nucleic acid extraction methods.3 

The Simplexa® COVID-19 Direct kit allows for fast results directly from nasal swab, nasopharyngeal swab, and BAL specimens, eliminating traditional RNA extraction steps. This enables faster turnaround times to help improve patient management and prevent further transmission of the disease.

The assay has demonstrated excellent clinical agreement and turnaround time, allowing for optimal allocation of critical resources and effective patient management decision making.4, 5

To learn more about DiaSorin’s response to the COVID-19 outbreak, visit https://diasoringroup.com/.

1. Centers for Disease Control and Prevention. (2020). Coronavirus. https://www.cdc.gov/coronavirus/index.html.
2. World Health Organization. (2020). WHO statement on cases of COVID-19 surpassing 100 000. https://www.who.int/news-room/detail/07-03-2020-whostatement-on-cases-of-covid-19-surpassing-100-000.
3. Centers for Disease Control and Prevention. (2020). Real-time RT-PCR panel for detection 2019-novel coronavirus. https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detection-instructions.html.
4. Zhen, W., Manji, R., Smith, E., & Berry, G. (2020). Comparison of four molecular in vitro diagnostic assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens. Journal of Clinical Microbiology. https://jcm.asm.org/content/early/2020/04/24/JCM.00743-20
5. Bordi, L., Piralla, A., Lalle, E., Giardina, F., Colavita, F.,…, & Capobianchi, M. R. (2020). Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexa™ COVID-19 Direct assay. Journal of Clinical Virology. https://www.sciencedirect.com/science/article/pii/S138665322030158X

Why to choose it

An easy to use sample to answer system – no extraction and all-in-one reagents. Comprehensive sample coverage including nasal swab, nasopharyngeal swab, and BAL specimens to work with any workflow.

Benefits

COVID-19
Highly Sensitive

Results You Can Depend On

The Simplexa® COVID-19 Direct assay targets two different regions of the SARS-CoV-2 genome to provide high sensitivity and help prevent false negatives.

Fast Results

Fast Time-to-Result

A simple workflow with minimal hands on time and results in a little more than an hour allows more efficient test reporting and patient management.

A Complete Solution

All You Need

The simplicity and flexibility of the LIASION® MDX system, combined with the broad sample coverage of the Simpexa® COVID-19 Direct assay design is a major step towards fighting the COVID-19 pandemic.

Reliability

Proven performance that you can count on

100% Clinical Agreement
Simplexa® COVID-19 Direct Clinical Agreement Study
Sample TypeSample Type Positive % Agreement Negative % Agreement
Sample TypeNasal Swab Positive % Agreement100% (30/30) Negative % Agreement100% (30/30)
Sample TypeNasopharyngeal Swab Positive % Agreement100% (52/52) Negative % Agreement100% (56/56)
Sample TypeBronchoalveolar lavage (BAL) Positive % Agreement100% (11/11) Negative % Agreement100% (7/7)


Ordering info

Product Code Reactions
Product

Simplexa® COVID-19 Direct

Code MOL4150 Reactions 24
Product

Simplexa®COVID-19 Positive Control Pack

Code MOL4160 Reactions 10
Product
  • This test has not been FDA cleared or approved.
  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Code Reactions

Our repository

All the answers you need.
Access our database to find:
instructions for use, safety data sheets,
assay protocols and more.

Access our repository