CELLEX qSARS-CoV-2 IgG/IgM RAPID TESTRELIABLE & ACCURATECombined IgG/IgM AntibodiesSensitivity 93.8%Specifi city 96.0%

Cellex qSARS-CoV-2 IgG/IgM Rapid Test was more accurate at ruling out cases, showing a 99.7% negative predictive value at 5% prevalence.

Combined Serology Test IgG and IgM Antibodies

Rapid Test Results in 15 minutes

Simple Swabs not required Simple whole blood test

Self-contained No lab equipment needed

Portable Cassette testing in any location

QUALITY CONTROLThe Cellex qSARS-CoV-2 IgG/IgM Rapid Test offers quality control throughout manufacturing, and also at the point of care.

Cellex maintains a GMP manufacturing, which is ISO 13485 certifi ed and in compliance with U.S. FDA’s QSR (Quality System Regulation).

As an extra assurance of quality at the point of care, Cellex provides two layers of quality control:

1. Internal Control: Each test contains a built-in control feature, the C Line. The C Line develops after addition of the specimen and sample diluent. If the C Line does not develop, the test is invalid.

2. Positive and Negative Control Set: Available separately, this set can be used to ensure the proper performance of the assay to validate the tests.

Our COVID-19 Antibody Rapid Test has received FDA Emergency Use Authorization (EUA) and was developed by Cellex, a U.S. biotechnology company.

Let’s work together to address this public health crisis. Nextteq International LLC, headquartered in Tampa, Florida, is a trusted global leader in the industrial hygiene and health and safety industries. We are a focused, results-driven organization with a management team comprised of entrepreneurs, a Ph.D, board-certifi ed industrial hygienist, a board-certifi ed safety professional, and a board-certifi ed toxicologist. Our critical mission right now is to help drive accurate, widespread, affordable testing for COVID-19. Nextteq International is an exclusive partner of HealthDatix, a U.S. healthcare technology company on the front lines of developing solutions for fi ghting the COVID-19 pandemic. Together, we are addressing this public health crisis. Early diagnosis and early treatment are vitally important to mitigate the number of COVID-19 patients who will require hospitalization. Accurate assessment of those who are infected, especially those who are asymptomatic, is also critical to opening workplaces and getting our economy on the road to recovery.

DATA. ANALTYICS. HEALTH.

Box of 25 Rapid Tests with proven accurate results in 15 minutes.

Results in 15-20 Minutes

1) Add 10ul sample 2) Add 2 drops of sample diluent 3) Read results in 15-20 minutes

Interpretation of Results

Negative Positive Invalid

THREE SIMPLE STEPS

As the fi rst line of defense against viral infection, human IgM antibody generally begins to rise within a few days of initial infection. The presence of IgM indicates a current infection. The IgG antibody appears about 14 days after infection, and may remain present for several weeks or even months. The presence of IgG indicates a recent or past infection. The detection of human IgG/IgM antibodies in blood not only serves as evidence of viral exposure, but also provides information about the stage of infection and possible antibody protection.

Accurate and earlier detection of the virus allows for better healthcare outcomes. Accurate assessment of past exposure, with assumed acquired immunity, can be vital information as well. This Rapid Test has proven 93.8% accurate for positive test (95% Confi dence Interval 88.1% - 97.3%) and has proven 96.4% accurate for negative tests (95% Confi dence Interval 92.3-97.8%) in detecting presence or lack of COVID antibodies.

With the information it provides, we can all work together to get people back to work and reboot our economy, while ensuring the safety of all and slowing the spread.

15-20 mins

PN Product Description

5515C025 Cellex qSARS-- CoV-- 2 IgG/IgM Rapid Test 25ct (Whole Blood/Serum/Plasma)

5515 Cellex qSARS-- CoV-- 2 IgG/IgM Positive/Negative Control Set

©2020 Nextteq International LLC, All rights reserved. Nextteq is a registered trademark of Nextteq International LLC. All other brand names and trademarks mentioned in this document are the properties of their respective holders. All features, specifications, and prices are subject to change without notice. P/N NX90200 5/20

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