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LIAISON® SARS-CoV-2 S1/S2 IgGThe fully automated serology test for the detection of SARS-CoV-2 IgG Antibodies

LIAISON® SARS-CoV-2 S1/S2 IgGSpecialty testing simplified

The LIAISON® XL solution consolidates COVID-19 testing with other specialty testing like QuantiFERON®-TB Gold Plus for latent tuberculosis, Procalcitonin for bacterial co-in-fections, and a robust menu of other infectious diseases.

Coronavirus is a common family of viruses, responsible for the common cold (strains 229E, NL63, OC43, HKU1), the SARS epidemic of 2003 and MERS. COVID-19 is a respira-tory infectious disease caused by the newly discovered coronavirus strain SARS-CoV-2. The first cases were reported by Chinese authorities in December 2019, in Wuhan City, Hubei province. The initial outbreak in Wuhan spread rapidly, first affecting other re-gions of China and then an increasing number of countries world-wide. The Director General of the World Health Organization declared COVID-19 a global pandemic on 11 March 2020. (1)

COVID-19 and SARS-CoV-2: Background

Timing of seroconversion is a key factor in establishing the appropriate time window to use serology tests. Recent publications indicate that the median for IgG seroconversion is between 7 and 14 days after disease onset. Our own data indicates that the test positive percent agreement with PCR positive results is highest after day 15.

Furthermore, since viral RNA can be detected in patients after 20 or more days. A positive IgG result should not be interpreted as a sign that a patient has stopped being infective.

Timing of COVID-19 immune response

0 5 12 26 35

Convalescence

Onset ofsymptomsRNA and IgG trends

in COVID-19 infection.This figure is for illustrative

purpose only.

SARS-CoV-2RNA and Antigen

IgG antibody

LIAISON®

SARS-CoV-2 S1/S2 IgG is Designed to

meet Clinical Need:

• A fully automated qualitative solution for the detection of IgG antibodies against S1/S2 antigens of SARS-CoV-2

• Random access with up to 170 patient results/hour on LIAISON® XL and 35 minutes to first result

• Excellent performance to assure accurate results, including no observed cross reactivity to other Coronavirus strains

®

1. European Centre for Disease Prevention and Control (ECDC). Novel Coronavirus. Available from: https://www.ecdc.europa.eu/en/novel-coronavirus-china (last page update March 24 2020)

Using Spike antigens for better

diagnostic results

The LIAISON® SARS-CoV 2 IgG assay specifically identifies antibodies against the S1 and S2 proteins of the virus: these two proteins are responsible for the binding and fusion of the virus to the host cell.

Spike is the protein on the viral surface which is responsible for entry into the host cell. The spike protein and its subunits are the main antigen targets for neutralizing antibodies, the antibodies usually thought to be responsible for protective immunity. Please note that due to lack of scientific evidence to date, the protective role of neutralizing antibodies in CoVID-19 is still to be confirmed.

By using antigens expressed in human cells we achieve proper folding, oligomer formation, and glycosylation, providing material similar to the native spikes and ensuring high negative percent agreement.

Agreement with presumed negative

samples

One thousand ninety presumed SARS-CoV-2 negative samples from a European laboratory routine (n=90) and European blood donors (n=1000) were tested resulting in 99.3% negative percent agreement.

Additionally, no cross reactivity to other Coronavirus strains was observed.

Non-SARS Human Coronavirus Condition Number of tested samples LIAISON® XLPositive results

Anti-Human CoV OC43 3 0

Anti-Human CoV HKU1 1 0

Anti-Human CoV unknown strain 4 0

Total 8 0

Agreement with PCR Positives

The positive percent agreement was determined by investigating 135 samples collected over the course of time from 76 European patients. Infection with SARS-CoV-2 was confirmed by RT-PCR test at the time of the diagnosis.

Positive percent agreement was evaluated separately for early samples (≤ 5 days after diagnosis), samples between 6 and 14 days after diagnosis, and later samples (> 15 days after diagnosis).

Days from Diagnosis Total IgG Results Positive Percent Agreement with PCR Comparator

(95%CI)

≤ 5 days 11/44 25.00% (14.57% to 39.44%)

6-14 days 44/49 89.80% (78.24% to 95.56%)

≥15 days 40/41 97.56% (87.40% to 99.57%)

LIAISON® SARS-CoV-2 S1/S2 IgGOrdering information & Specs

Controls

LIAISON® SARS-CoV-2 S1/S2 IgG 311460

KIT FORMAT 110 tests/ 110 patient results

TIME TO FIRST RESULT 35 min

THROUGHPUT Up to 170 test/hour

OPEN/ON BOARD KIT STABILITY (at Launch) Up to 1 week

Expected OPEN/ON BOARD KIT STABILITY Up to 4 weeks

CALIBRATION STABILITY (at Launch) Up to 1 week

Expected CALIBRATION STABILITY Up to 4 weeks

No potential cross-reactivity with other coronaviruses observed

Samples tested: 3 Anti-Human CoVOC43; 1 Anti-Human CoV HKU1, 4Anti-Human CoV unknown strain.

LIAISON® Control SARS-CoV-2 S1/S2 IgG 311461

KIT FORMAT 2 levels x 2 vials (up to 40 runs)

Open/on board controls stability Up to 4 weeks

Please visit: www.diasorin.com/covid19USfor more information and updates

LIAISON® is a registered trademark of DiaSorinAvailable only on Product availability subject to required regulatory approval

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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 IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

DiaSorin Inc.1951 Northwestern Avenue PO BOX 285MN 55082 - 0285 Stillwater Minnesota United Stateswww.diasorin.com