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WELLlife COVID-19 Antigen Home Test two-test OTC kit

WELLlife COVID-19 Antigen Home Test (2 Tests/Kit)

$5.90

FDA 510(k) Cleared
OTC Home Test
2 Tests per Kit
10-Minute Results

2 tests per kit
•
Anterior nasal swab

The WELLlife™ COVID-19 Antigen Home Test is an FDA 510(k)-cleared, over-the-counter lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens. It is intended for people with COVID-19 symptoms during the first five days after symptom onset.

  • For self-testing by individuals age 14 or older
  • Adults may collect and test samples from individuals age 2 or older
  • Read results at 10 minutes; do not read before 10 or after 20 minutes
  • If the first result is negative, retest once between 48 and 72 hours later

WELLlife COVID-19 Antigen Home Test Overview

The WELLlife™ COVID-19 Antigen Home Test is a visually read lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens. This two-test kit is intended for non-prescription home use by symptomatic individuals during the first five days after symptoms begin.

Individuals age 14 or older may collect and test their own sample. An adult must collect and test the sample for individuals ages 2 through 13.

FDA 510(k) Cleared
OTC Home Use
2 Tests per Kit
10-Minute Results

Features and Benefits

FDA 510(k) cleared
Cleared as an over-the-counter COVID-19 antigen test under K241317.

Non-prescription home use
No prescription or laboratory equipment is required.

Anterior nasal swab
Uses the included swab to collect a sample from both nostrils.

Two-test configuration
Provides a second test for the required repeat testing after an initial negative result.

Reference
WL03P0001-2
SKU
DTK-209210
Package
2 tests per kit
FDA 510(k)
K241317

Important intended-use information: This test is for individuals with signs and symptoms of COVID-19 during the first five days after symptom onset. Do not use it when you have no symptoms or when symptoms have lasted longer than five days.

Who Can Use This Test?

User or Patient Authorized Use
Age 14 or older May self-collect the anterior nasal swab and perform the test
Age 2 through 13 An adult must collect the sample and perform the test
Under age 2 Do not use this test

What Is Included?

Component Quantity
Test cassettes 2
Pre-filled extraction-buffer tubes 2
Nasal swabs 2
Quick Reference Instructions 1

Components included with the WELLlife COVID-19 Antigen Home Test

A timer or clock is required but is not included. The kit box contains a tube holder used during the procedure.

How to Perform the Test

Step Instruction
1 Wash and dry your hands. Confirm that the test is not expired and allow all components to reach room temperature.
2 Remove the large blue cap from the tube and place the tube in the holder built into the kit box.
3 Insert the absorbent swab tip approximately 3/4 inch into one nostril. Brush the nasal wall in a circular motion at least five times, then repeat in the other nostril using the same swab.
4 Place the swab into the tube, stir it vigorously at least 15 times and leave the swab in the tube for 1 minute.
5 Remove the swab while squeezing the sides of the tube to express the liquid. Replace the large blue cap.
6 Open the small white cap and add four drops to the sample well of the test cassette.
7 Read the result at 10 minutes. Do not interpret the result before 10 minutes or after 20 minutes.
This summary does not replace the manufacturer’s instructions. Read the complete Quick Reference Instructions and Instructions for Use before testing.

Understanding the Results

Result Lines Shown What It Means
Positive Control line (C) and any visible test line (T) SARS-CoV-2 antigen was detected. A faint pink or purple T line is still positive.
Negative Control line (C) only SARS-CoV-2 antigen was not detected. The result is presumptive and repeat testing is required.
Invalid No control line (C) Repeat the test with a new kit and a new sample.

Clinical Performance

Measure Result 95% Confidence Interval
Positive Percent Agreement (PPA) 84.38% (108/128) 77.10%–89.65%
Negative Percent Agreement (NPA) 99.67% (901/904) 99.03%–99.89%
Performance was evaluated in symptomatic subjects tested within five days after symptom onset. PPA and NPA are measures of agreement with an FDA-cleared molecular comparator and should not be described as a general “percent accurate” claim. Test accuracy may change as new SARS-CoV-2 variants emerge.

Repeat Testing After a Negative Result

All negative results are presumptive. A symptomatic individual with an initial negative result must be tested again once between 48 and 72 hours after the first test, using either an antigen test or a molecular test for SARS-CoV-2. A positive result does not require repeat testing.

Storage

  • Store the kit in a dry place at 36–86°F (2–30°C).
  • Do not use the kit after the expiration date printed on the box or pouch.
  • Allow all test components to reach 59–86°F (15–30°C) before use.

Instructions and Regulatory Documents

Quick Reference Instructions

Instructions for Use

FDA 510(k) Summary – K241317

Frequently Asked Questions

What does the WELLlife COVID-19 Antigen Home Test detect?

It qualitatively detects SARS-CoV-2 nucleocapsid protein antigen in an anterior nasal swab specimen.

Is this an over-the-counter home test?

Yes. It is FDA 510(k) cleared for non-prescription home use.

Is the test FDA cleared or authorized under an EUA?

This product is FDA 510(k) cleared under K241317. It should not be described as an EUA-only product.

Can the test be used without COVID-19 symptoms?

No. The current cleared instructions specify use by individuals with signs and symptoms of COVID-19 during the first five days after symptom onset.

What ages can use the test?

Individuals age 14 or older may test themselves. An adult may collect and test a sample from an individual age 2 or older. Do not use the test on children under age 2.

How quickly are results available?

Read the result at 10 minutes. Do not read it before 10 minutes or after 20 minutes because this may produce a false or invalid interpretation.

Why are two tests included?

If the first result is negative, symptomatic individuals must test again once between 48 and 72 hours later. The second test supports that repeat-testing requirement.

What does a faint test line mean?

Any visible pink or purple test line (T), even if faint, together with a visible control line (C), should be read as positive.

What does a negative result mean?

A negative result means SARS-CoV-2 antigen was not detected, but it does not rule out infection. Repeat testing is required, and continued or worsening symptoms should be discussed with a healthcare provider.

How should the test be stored?

Store the kit in a dry place at 36–86°F (2–30°C) and do not use it after the expiration date printed on the packaging.

Looking for current COVID-19 testing information?

Review guidance and general testing information from the Centers for Disease Control and Prevention.

Review CDC Testing Information

Additional information

Weight 0.5 lbs
Dimensions 6 × 2.5 × 1 in

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