Simplexa® COVID-19 Direct Kit

Enabling Swift Action Against the COVID-19 PandemicQualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA

INFECTIOUS DISEASE

The quality of treatment starts with diagnosis.

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 rapid results directly from nasopharyngeal swab specimens (NPS), eliminating traditional RNA extraction steps. This enables faster turnaround times to help improve patient management and prevent further transmission of the disease.

Rapid and reliable testing for SARS-CoV-2 viral RNA

• Sample type: Validated for nasopharyngeal swab specimens.

• Fast time-to-result: Results delivered in a little more than an hour. No RNA extraction required and kit contains ready to use, all-in-one reagent mix.

• Highly sensitive: Limit of Detection (LoD) of 500 copies/mL.

Simplexa® COVID-19 Direct Kit

Enabling Swift Action Against the COVID-19 PandemicA real-time PCR assay for the in vitro qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA.

REFERENCES: 1. Centers for Disease Control and Prevention. (2020). Coronavirus. Retrieved from https://www.cdc.gov/coronavirus/index.html 2. World Health Organization. (2020). WHO statement on cases of COVID-19 surpassing 100 000. Retrieved from https://www.who.int/news-room/detail/07-03-2020-who-statement-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. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detection-instructions.html.

INFECTIOUS DISEASE

Streamlined, simple workflow

SCAN samples and reagents.

PIPETTE samples and reagents directly onto the disc.

LOAD and press RUN.

Proven performance that you can count onThe clinical performance of the Simplexa® COVID-19 Direct Assay was established in multi-site clinical evaluation. Fresh clinical NPS specimens were tested with the Simplexa COVID-19 Direct Assay at three (3) different clinical sites from February 2020 to March 2020.

For each of the sites, an established comparator was used. Sites 1 and 3 used the same comparator while Site 2 used a different comparator assay. The sample to answer Simplexa® COVID-19 Direct Assay demonstrated excellent performance when compared to more complex extraction based COVID-19 Assays.

Simplexa™ COVID-19 Direct Clinical Agreement3

SAMPLE TYPE POSITIVE % AGREEMENT NEGATIVE % AGREEMENT

Nasopharyngeal Swab (All 3 Sites) 100% (52/52) 100% (56/56)

Simple and easy workflow enabling the assay to be run on any shift and bypass conventional RNA extraction procedures.

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Simplexa, LIAISON MDX, and the associated logos are all trademarks or registered trademarks of DiaSorin Molecular LLC, or its affiliate, in the U.S. and/or other countries. ©2016 DiaSorin Molecular LLC. All rights reserved

The Simplexa COVID-19 Direct test has not been FDA cleared or approved. The test has been authorized by FDA under an EUA for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Simplexa COVID-19 Direct 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.

Black Hole Quencher, CAL Fluor, Quasar dyes are trademarks of Biosearch Technologies, Inc. DiaSorin products incorporating the Black Hole Quencher, CAL Fluor, and Quasar dye technology are licensed and sold pursuant to an agreement with Biosearch Technologies, lnc., and these products are sold exclusively for clinical, diagnostic, or research and development purposes.

Product availability subject to required regulatory approvals.

Contact DiaSorin Molecular today! Call +1 (562) 240-6500 or visit: www.molecular.diasorin.com

Your solution for COVID-19 testing

Ordering information – Simplexa® COVID-19 Direct Kit

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL4150 Simplexa® COVID-19 Direct Kit* 24

MOL4160 Simplexa® COVID-19 Positive Control Pack 10 *Direct Amplification Discs included with kit.

Other Simplexa® Respiratory Products

Ordering information – Other Simplexa® Direct Kits

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2750 Simplexa® Bordetella Direct Kit* 24

MOL2760 Simplexa® Bordetella Positive Control Pack 10

MOL2650 Simplexa® Flu A/B & RSV Direct Kit* 24

MOL2660 Simplexa® Flu A/B & RSV Positive Control Pack 10

MOL2850 Simplexa® Group A Strep Direct Kit* 24

MOL2860 Simplexa® Group A Strep Positive Control Pack 10

*Direct Amplification Discs included with kit.