Introduction

The iHealth Labs Antigen Rapid Test Nostril ICO-3000 is a user-friendly diagnostic tool designed for quick and accurate COVID-19 testing. This FDA-authorized test provides results in just 15 minutes, making it ideal for both personal and professional use. With a simple nostril swab procedure, it ensures minimal discomfort while delivering reliable results. Priced at approximately $19.99 for a single test, it offers an accessible solution for timely COVID-19 detection.

Detailed Specifications

The iHealth Labs Antigen Rapid Test Nostril ICO-3000 boasts several key features that make it a reliable and user-friendly option:

• Rapid Results: Provides test results within 15 minutes.
• Nostril Swab: Less invasive compared to nasopharyngeal swabs.
• High Accuracy: Demonstrates high sensitivity and specificity for detecting COVID-19 antigens.
• Easy to Use: Simple instructions and minimal steps required for testing.
• Portable: Compact design allows for easy storage and transport.
• CE and FDA Approved: Meets regulatory standards for safety and efficacy.

Description

The iHealth Labs Antigen Rapid Test Nostril ICO-3000 is designed with user convenience in mind. The kit includes a nostril swab, a test cassette, and a buffer solution. The process involves gently swabbing the nostril area, mixing the swab with the buffer solution, and then applying the mixture to the test cassette. After a short wait, the test results will appear on the cassette, indicating either a positive or negative result.

This product is ideal for individuals who need quick and reliable COVID-19 testing without the need for a healthcare professional. It is also suitable for frequent testing, such as before gatherings or travel, helping to ensure safety and peace of mind.

Step by Step Instructions

Prepare Materials

Open the package, take out the COVID-19 Test Card in Pouch, the Tube filled with the extraction buffer and the Swab. When you are ready to proceed with the test, open the foil pouch of the COVID-19Test Card.

Collect Sample

1. Remove the swab from its package, being careful not to touch the tip of the swab. Please keep the swab package for later use.

2. Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril.

   

   Note:  With children, the maximum depth of insertion into the nostril may be less than 3/4 of an inch, and you may need to have a second person to hold the child's head while swabbing.

3. Firmly and slowly brush against insides of nostril in a circular motion against the nasal wall at least 5 times. Take at least 15 seconds to collect the specimen and be sure to collect any nasal drainage on the swab. Using the same swab, repeat the same sample collection procedure for the other nostril. Be sure to brush BOTH nostrils with the SAME SWAB.

   

Note: Failure to swab properly may cause false negative results.

Process Sample

1. Tap the tube vertically on the table and twist the large orange cap to open the tube. 

   

2. Insert the swab into the tube, touch the bottom of the tube with the swab tip, and stir at least 15 times.

3. Squeeze the sides of the tube to express as much liquid as possible from the swab, and then remove the swab.

   

   Note:  If you don't squeeze the swab, there may not be sufficient sample material to perform the test properly (i.e., potentially resulting in a false negative result).

4. Screw back the large orange cap, put the swab back into the package. Safely dispose of the swab and the package.

   

Add Sample

Twist to open the small white cap of the tube. Add 3 drops of sample to the Sample Port of the COVID-19 Test Card. Screw back the small white cap.

Note: 
A false negative or invalid result may occur if too little solution is added to the test card.

Wait 15 Minutes

Start the timer by clicking the "Start Timer" button, immediately after adding sample to the Sample Port. The result will be ready in 15 minutes.

Note: 
Do NOT interpret your test result until after your 15-min timer has completed, as the T line may take as long as 15 minutes to appear.

Read Result

Results should not be read after 30 minutes (Result shown at 2x magnification). 
Note: A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes.

Note: The T line can be extremely faint.

Test Result Explanation

Positive Result

A POSITIVE result must show BOTH a C line and a T line. A positive result means that viral antigens from COVID-19 were detected and the individual is positive for COVID-19. 
Below are photos of actual positive tests. Please note that the T line may be faint.

Persons who test positive should self-isolate and seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary.

Negative Result 

A NEGATIVE result will show ONLY a C line. A negative result means that viral antigens from COVID-19 were not detected and that the individual is presumed negative for COVID-19.

• Please note that negative results do not rule out COVID-19.
• In case of negative test result: Continue to follow all social distancing recommendations and take protective measures. If suspicions of infection persist and/or your first test is negative, repeat the test after 1-2 days and consult your healthcare provider or local COVI D-19 center.
• Note: A negative result is presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Individuals without symptoms that test negative should be tested again with at least 24 hours and no more than 48 hours between tests. Additional confirmatory testing with a molecular test for negative results may be necessary after second negative result for asymptomatic patients, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with as close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.

Invalid Result

If there is NO LINE, or if there is ONLY a T line, the test is INVALID. Invalid result means that the test did not function correctly. You will need to retest with a new test kit. If upon retesting, the test result is still invalid, contact your doctor or local COVID-19 center. An invalid result does not indicate if the individual did or did not have COVID-19 and should be repeated.

Dispose the Test Kit

After test is completed, dispose the kit components in trash.

Report Test Result

Report the result following the App instructions or share your test result with your healthcare provider. 
In the USA:

1. This test is intended to be used as an aid to the clinical diagnosis of a current COVID-19 infection, Do not use this test as the only guide to manage your illness.
2. In USA: This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other virus 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.

Setup Guide

To operate the iHealth Labs Antigen Rapid Test Nostril ICO-3000, follow these steps:

1. Open the test kit and remove all contents.
2. Take the nostril swab and gently insert it into one nostril about 1-2 cm deep.
3. Rotate the swab 5-10 times to collect a sufficient sample.
4. Remove the swab from your nostril and insert it into the buffer solution vial.
5. Mix the swab with the buffer solution by rotating it 5-10 times.
6. Add 3 drops of the solution to the test cassette.
7. Wait 15 minutes for the results to appear on the cassette.

INTENDED USE

The iHealth COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. This test is also authorized for non-prescription home usewith adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset.

This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

The Health COVID-19 Antigen Rapid Test does not  differentiate between SARS-CoV and SARS-CoV-2.Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with pastmedical history and other diagnostic information is necessary to determine infection status. Positive results donot rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the Health" COVID-19 Antigen Rapid Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Negative results are presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of an individual's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, it there is a nigh likelinood of SAKS-LOV-2 meccon, such as in an indmoual wiin as a close contact with covid-19 or with suspected exposure to covid-1s or in communities with high prevalence of infection.Additional confrmatory testing with a molecular test for positive results may also be necessary, i there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.

Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider.

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting or by following the mobile application instructions for self-reporting. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as dehned by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. The iHeath° COV D-19 Antigen Rapid Test is authorized for non-prescription self-use and or, as applicable for an adult lay user testina another person aged 2 vears or o der. The iHealth? COV D-19 Antigen Rapid Test is onlvi for use under the Food and Drua Administration's emergency use humorization.

WARNINGS AND PRECAUTIONS

• Testing for asymptomatic individuals should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.
• There is a higher chance of false negative results with home-use tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19
• Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms.
• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
• This test is intended for diagnosis of coronavirus infection by detecting COVID-19 antigen but should not be used as a sole criterion for the determination of SARS-CoV-2 infection. Other laboratory tests and clinical information (signs and symptoms) should be used and considered for diagnosis.
• Do not use on anyone under 2 years old.
• Children aged 2-14 years should be tested by an adult.
• Do not use on anyone who is prone to nosebleeds or has had facial or head injury/surgery in the last 6 months.
• Do not use any test component after the expiration date which is printed on the outer packaging.
• Do not use the COVID-19 Test Card if the pouch is damaged or if the seal is broken.
• Do not reuse any test component.
• To obtain accurate results, the test must be performed as indicated in the application (iHealth COVID-19 Antigen Rapid Test) and/or Instructions for Use.
• Once the COVID-19 Test Card is removed from the pouch, perform the test as soon as possible. Use the COVID-19 Test Card within 1 hour after opening the foil pouch.
• Inadequate or inappropriate sample collection may yield false test results.
• Do not touch the tip of the swab before and after collecting the sample from the nostrils.
• Insert the swab into the tube right after taking the sample.
• Test samples immediately after collection, but no more. than 4 hours after specimen collection before placement into extraction butter or up to 2 hours after placement into extraction butter, it kept at room temperature. Be sure to read the test result after 15 minutes. Do not read the results after 30 minutes.
• The sure to read test results within 15-30 minutes.
• Do not ingest extraction liquid.
• Keep test kits and components out of the reach of children and pets betore and after use.
• Avoid contact with skin and eyes.
• The reagent in the extraction liquid contains ProClin" 300 which may cause an allergic skin reaction in some people. The solution makes contact with the skin or eye. wash/flush with copious amounts of water. If skin irritation or rash occurs get medical advice/attention.

STORAGE AND OPERATION CONDITIONS
Store iHealth COVID-19 Antigen Rapid Test in a dry place between 36-86 °F (2-30 °C). Ensure all test components are at room temperature 65-86 F (18-30 "C) betore use. It is stable before the expiration date marked on the packaging.

Troubleshooting

If you encounter any issues during the testing process, here are some common problems and solutions:

• No Results After 15 Minutes: Ensure that you have added the correct number of drops to the test cassette. If still no results appear, consider contacting customer support or repeating the test.
• Inconclusive Results: This can occur if the sample is not collected correctly or if there is an issue with the test kit. Repeat the test following the instructions carefully.
• Incorrect Use of Swab/Bufffer Solution: Always follow the instructions provided to avoid contamination or incorrect use of components.

iHealth Labs Antigen Rapid Test Nostril ICO-3000 Pros & Cons

Pros

• Rapid Results: Quick detection within 15 minutes.
• Easy to Use: Simple and straightforward testing process.
• Portable & Compact: Easy storage and transport.
• Affordable Pricing: Competitive pricing for home testing.

Cons

• Less Sensitive Than PCR Tests: May not detect all cases of COVID-19, especially in early stages or with low viral loads.
• Requires Correct Technique: Inadequate swabbing technique can lead to inaccurate results.
• Not Suitable for All Ages: Not recommended for young children without adult supervision.

Customer Reviews

Customers have generally praised the iHealth Labs Antigen Rapid Test Nostril ICO-3000 for its ease of use and rapid results. However, some users have noted that accurate results depend heavily on proper swabbing technique and following instructions precisely.

Common complaints include occasional inconclusive results and the need for precise handling to avoid errors. Despite these minor issues, many customers appreciate the convenience and reliability offered by this product.