Rapid home covid 19 test kit
The iHealth® COVID-19 rapid home covid 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 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 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 iHealth® 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 past medical history and other diagnostic information is necessary to determine infection status.
Summary and Explanation of Rapid covid-19 home test kit
- For use with anterior nasal swab specimens
- For in vitro Diagnostic Use Only
- This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA)
- Results in 15 minutes
- No equipment or training needed
- Bulk covid test price available
It can be used as a:
- Covid test for Home use
- Covid test for Schools
- Covid test for Travel
- Covid test for Business
- Covid test for International travel
Documentation:
Reading the Covid rapid antigen test
Positive - A line appears in regions (C) and (T)
The presence of both the control line (C) and line (T) indicates the presence of SARS-CoV-2 antigens. The result suggests current COVID-19 infection.
Negative - A line appears in region (C)
The presence of only the control line (C) and not the line (T) indicates no detection of SARS-CoV-2 antigens.
Invalid - No line appears in region (C)
If the control line (C) does not appear, the result is invalid, regardless whether the line (T) is present. Repeat the test with a new test kit.
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.
How to use iHealth rapid home covid tests
iHealth covid test kit
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-19 Test Card.
SWAB
Firmly and slowly brush against the insides of the nostril in a circular motion against the nasal wall at least 5 times. Using the same swab, repeat the same sample collection procedure for the other nostril. Take at least 15 seconds to collect the specimen and be sure to collect any nasal drainage on the swab. Be sure to brush BOTH nostrils with the SAME SWAB.
Dip
Tap the tube vertically on the table and twist the large orange cap to open the tube. Insert the swab into the tube, touch the bottom of the tube with the swab tip, and stir at least 15 times.
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.
Read results
Start the timer by clicking the “Start Timer” button, immediately after adding a sample to the Sample Port. The result will be ready in 15 minutes. 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.
Rapid antigen test for home use how it works
The iHealth® COVID-19 Rapid Home Covid Test employs lateral flow immunoassay technology. Using this test allows for the rapid detection of nucleocapsid protein from SARS-CoV-2.
To begin the test, a self-collected anterior nares swab samples in individuals aged 15 and older or individuals between the age of 2 to 14 a swab collected by a parent or guardian is inserted into the Tube. The liquid in tube interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The liquid in tube now containing the specimen is added to the Sample Port of the COVID-19 Test Card.
If the extracted specimen contains SARS-CoV-2 antigens, a pink-to-purple T Line, along with a pink-to-purple C Line will appear on the COVID-19 Test Card indicating a positive result. If SARS-CoV-2 antigens are not present, or present at very low levels, only a pink-to-purple C Line will appear.
Specimen Collection, Handling, and Transport indicated rapid covid test
STORAGE CONDITIONS
Store iHealth® COVID-19 home rapid test kit in a dry location between 36-86 °F (2-30 °C). Ensure all test components are at room temperature 65-86 °F (18-30 °C) before use. The COVID-19 Test Card inside the foil pouch should be used within 1 hour after opening. The iHealth® COVID-19 Antigen Rapid Test is stable before the expiration date marked on the packaging.
QUALITY CONTROL
A procedural internal control is built in the “control line (c)” of the device and is used to ensure that the applied specimen has migrated well into the device. It is coated with goat anti-rabbit IgG and a red colored line should appear after sample was added.
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