Simplexa
COVID-19 Direct Kit

Enabling Swift Action Against the COVID-19 Pandemic

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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 BAL, nasal swab, nasal wash/aspirate, nasopharyngeal swab and saliva 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 BAL, nasal swab, nasal wash/aspirate, nasopharyngeal swab and saliva specimens. The Simplexa COVID-19 Direct assay and the Simplexa Flu A/B & RSV Direct Gen II assay can be run on the same disc at the same time for differential diagnosis of SARS-CoV-2, Flu A, Flu B and RSV.

Benefits

Highly Sensitive

Results You Can Depend On

Simplexa COVID-19 Direct assay targets two different regions of the SARS-CoV-2 genome, the ORF1 ab and S gene. This provides high sensitivity and helps 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 LIAISON® MDX system, combined with the Simplexa COVID-19 Direct assay design is a major step towards fighting the COVID-19 global pandemic. The Simplexa COVID-19 Direct assay and the Simplexa Flu A/B & RSV Direct Gen II assay can also be run on the same disc at the same time for differential diagnosis of COVID-19 and flu from one patient  sample.

Reliability

Proven performance that you can count on

Greater than 96% Clinical Agreement
Simplexa COVID-19 Direct Clinical Agreement Study
Sample TypeSample Type Positive %
Agreement
Negative %
Agreement
Sample TypeBronchoalveolar
lavage (BAL)
Positive % Agreement100%
(11/11)
Negative % Agreement100%
(7/7)
Sample TypeNasal
Swab
Positive % Agreement100%
(30/30)
Negative % Agreement100%
(30/30)
Sample TypeNasal Wash/
Aspirate
Positive % Agreement96.7%
(29/30)
Negative % Agreement100%
(30/30)
Sample TypeNasopharyngeal
Swab
Positive % Agreement100%
(60/60)
Negative % Agreement100%
(127/127)
Sample TypeSaliva Positive % Agreement100%
(30/30)
Negative % Agreement100%
(30/30)


Ordering info

Product Code Reactions
Product

Simplexa COVID-19 Direct Kit

Code MOL4150 Reactions 24
Product

Simplexa™ COVID-19 Positive Control Pack

Code MOL4160 Reactions 10
Product Code Reactions

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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