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CLINITEST^® Rapid COVID-19 Antigen Self-Test - USA

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CLINITEST® Rapid COVID-19 Antigen Self-Test

As of October 12, 2022 the Food and Drug Administration has granted a shelf-life extension for the CLINITEST® Rapid COVID-19 Antigen Self-Test from 11 months to 24 months. For more information click here.

Monitoring Variants of Concern

Siemens Healthineers is committed to monitoring all current and emerging variants of concern (VOCs) by directly testing with clinical samples and using a computer-based inspection tool called in silico analysis. The Omicron variant (B.1.1.529) is recognized by the WHO, CDC, and ECDC as a VOC. Siemens Healthineers internal data demonstrate that the CLINITEST® Rapid COVID-19 Antigen (Self) Test detects SARS-CoV-2 virus/coronavirus infection of the Omicron variant and its major sub-variants, including BA.1, BA.2, BA.2.75, BA.3, BA.4, BA.4.6, BA.5, BF.7, and XE.

Be ready for the moments that matter

CLINITEST® Rapid COVID-19 Antigen Self-Test now available in the United States

From everyday activities to important milestones, and all the moments in between, feel better and safer in the company of others. With the CLINITEST® Rapid COVID-19 Antigen Self-Test, you can expect accurate and reliable results in just 15 minutes. Whether or not you have symptoms of COVID-19, all it takes is a quick, easy, and gentle nasal swab for peace of mind today. Available at Amazon

CLINITEST Rapid Covid-19 Antigen Self-Test box cartridge prefilled tube

Where to buy

Kit contents

What will you find in your kit?

Each test kit contains materials to perform 5 rapid antigen tests.

Sterile swab

Instructions

Test cassette

Pre-filled extraction tube

Test pouch

Test kit and workstation

Dropper tip and filter

How to use

How to use the CLINITEST® Rapid COVID-19 Antigen Self-Test

Video: Ready to get started?

Testing using the CLINITEST self-test is simple. All you need is right in your kit. When you are ready to conduct your test, watch this video to help guide you through the instructions.

Six easy steps to run a test

The back of the box of the Siemens Healthineers CLINITEST Rapid COVID-19 Antigen Self-Test — The tube holder is on the back of the packaging where there is an outlined hole.

Step 1: Locate tube holder

Find the tube holder shown on the back of the box.

Push the tube through the outlined hole.

A close up of the foil being removed from the tube of the CLINITEST self-test — Remove the foil from the tube carefully.

Step 2: Remove foil

Remove foil seal from the tube. Avoid spilling the liquid.

A blonde woman inserts a nasal swab into her nose in order to perform a COVID-19 self test at home — After inserting the swab, rub the insides of each nostril at least 5 times.

Step 3: Open swab

Open the swab pouch and carefully rub the insides of each nostril in a complete circle at least 5 times.

A blonde woman stands in her kitchen with the Siemens Healthineers CLINITEST Rapid COVID-19 Self Test on the counter rolling her nasal swab in the test tube to perform a COVID test at home — Roll the swab 6 times against the bottom and sides of the tube.

Step 4: Place swab in tube

Remove the tube from the tube holder and insert the swab tip into the liquid. Roll the swab 6 times against the bottom and sides of the tube.

Keep the swab in the tube and place it back into the tube holder. Leave the swab in the tube for 1 minute.

A close up of a hand inserting a swab into the buffer of the Siemens Healthineers CLINITEST self test while performing a COVID test at home — When you are removing the tube, squeeze the tip several times from the outside of the tube.

Step 5: Remove swab from tube

After 1 minute, take the tube out of the holder and remove the swab from the tube. As you remove the swab from the tube, squeeze swab tip several times from outside of the tube. Try to release as much liquid from the swab as possible.

Locate the tube tip from the kit and push it into the top of the tube.

A close-up of a woman squeezing the test tube and adding 4 drops to the test cassette of the CLINITEST self test while performing a rapid COVID-19 test at home — Add 4 drops of solution into the sample well labeled "S".

Step 6: Add drops of solution into test cassette

Open the test device pouch and place the test cassette on a flat surface.

Holding the tube straight above the test cassette, gently squeeze to add 4 drops of solution into the sample well labeled "S".

Start a timer for 15 minutes. After 15 minutes, read the results.

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Download Instructions for Use

How to interpret the results

How do I know if the test result is positive, negative, or invalid?

Positive

If the test looks like this, then protein from the virus that causes COVID-19 was detected in the sample.

The test is positive if there are two pink/red lines present, one at the Control "C" line and one at the Test "T" line. Look very closely for a line next to "T". This line can be very faint.

Any visible pink/red "T" line is a positive result when the "C" line is also present.

Negative

If the test looks like this cassette, then protein from the virus that causes COVID-19 was not detected.

You will only see one line visible next to “C” and no line visible next to "T".

Invalid

If the test looks like either of these two test cassettes, then the test was not able to give a result and you must repeat the test with a new swab, a new tube, and a new test cassette.

The test is INVALID if there is no line next to "C".

Frequently asked questions

When should I use the CLINITEST self-test?

The test is intended to detect SARS-CoV-2 infections. It provides you with a result quickly to help make daily decisions safely and confidently.

Does the test work for children?

The test is is authorized for self-testing use by individuals ages 14 and older or adult-collected samples from individuals ages 2 to 13 years.

Is the test available over the counter (OTC)?

Yes, the product was granted Emergency Use Authorization (EUA) by the FDA and is available OTC in the United States. More information

The control line is barely visible. Is that OK?

As long as the control line is visible, test results are reliable. More information

What is the test's shelf life?

The Food and Drug Administration has granted a shelf-life extension for the CLINITEST® Rapid COVID-19 Antigen Self-Test from 11 months to 24 months from the date of manufacture.

How do I learn about COVID-19 test reimbursement?

Have more questions?

Contact

Contact information

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Buy on Amazon

In the USA, this product has not been FDA-cleared or approved but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Product availability may vary by country.

Distributed by Siemens Healthineers.

Please follow local government and health regulations and guidance with respect to COVID-19 health and safety.