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 and then a pandemic were declared.2

Currently, the pandemic is evolving with high concern for possible SARS-CoV-2 variants in regards to their transmissibility and impact on current vaccines or available immunotherapy.3 Testing needs have also shifted throughout the pandemic as global shortages of supplies created unique issues for laboratories all over the globe.4

The Simplexa® COVID-19 Direct kit (EUA) allows for fast results directly from nasopharyngeal swab, nasal swab, bronchoalveolar lavage (BAL) and nasal wash/aspirate specimens, eliminating traditional RNA extraction steps. This enables faster turnaround times to help improve identification of positive individuals, patient management, allocation of critical resources and prevent further transmission of the disease.5,6

The Simplexa® COVID-19 Direct kit detects the presence of SARS-CoV-2 RNA, including the variants Alpha (B.1.1.7), Beta (B.1.351), Gamma (P1), Delta (B.1.617.2), Epsilon (B.1.427/B.1.429), Zeta (P.2), Eta (B.1.525), Iota (B.1.526), Kappa (B.1.617.1) and Lambda (C.37).7

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. American Society for Microbiology. (2020). Laboratory supply shortages are impacting COVID-19 and non-COVID diagnostic testing. https://asm.org/Articles/2020/September/Laboratory-Supply-Shortages-Are-Impacting-COVID-19
5. 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
6. 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
7. World Health Organization. (2021). Tracking SARS-CoV-2 variants. https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/

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, nasal wash/aspirate, and BAL specimens to work with any workflow. The Simplexa® COVID-19 Direct assay and the Simplexa® Flu A/B & RSV Direct 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

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

Greater Than 96% 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 TypeNasal Wash/Aspirate Positive % Agreement96.7% (29/30) Negative % Agreement100% (30/30)
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.
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instructions for use, safety data sheets,
assay protocols and more.

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