Name: Healgen COVID-19 Rapid Antigen Test (20 Tests)
Brand: Medisave
SKU: healgen-covid-19-rapid-antigen-test-20-tests
Availability: InStock

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Healgen COVID-19 Rapid Antigen Test (20 Tests)

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Healgen COVID-19 Rapid Antigen Test (20 Tests)

This swab test is intended for the rapid detection of COVID-19 - results available within 15 minutes with high accuracy.

Each kit contains everything required to carry out the tests- no additional equipment is needed.
Approved by Public Health England & validated by the UK Government.
Results in 15 minutes.
Each kit includes clear instructions and is easy to use.
This test is not for non-clinical use.

Instructions for Use:

Remove the test cassette from the sealed foil pouch and use it as soon as possible.
Lay device on flat surface and add specimen. With the plastic dropper provided, draw specimen to exceed the specimen line, as shown in the diagram below.
Hold the dropper vertically and transfer drawn specimen into the sample well.
Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well, ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
Wait for the control line to change from blue to a red color.
If, after 2 minutes, the sample has not moved across the test window, add 1 additional drop of sample buffer to the buffer well.
The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

Test Procedure:

1. Specimen Collection

Use the nasopharyngeal swab supplied in the kit

Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx that presents the most secretion under visual inspection.

Swab over the surface of the posterior nasopharynx.

Rotate the swab several times. Withdraw the swab from the nasal cavity.

2. Sample preparation

Insert the test extraction tube into the workstation

Make sure that the tube is standing firm and reaches the bottom of the workstation

Add 0.3 mL (about 10 drops) of the sample extraction buffer into the extraction tube.

Insert the swab into the extraction tube which contains 0.3 mL of the extraction buffer. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube. Leave the swab in the extraction tube for 1 minute.

Squeeze the tube several times with fingers from outside of the to immerse the swab

Fit the dropper tip with filter on top the extraction tube tightly

Remove the swab. The extracted solution will be used as test sample.

3. Interpretation of Results

Allow the test device, test sample and buffer to equilibrate to room temperature prior to testing

Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

Ensure the nozzle with filter is fitted on to the sample extraction tube tightly.

Reverse the sample extraction tube, and add 4 drops (about 100 μL) of test sample by squeezing the extracted

solution tube into the sample window.

Wait for the colored band(s) to appear. The result should be read in 15 minutes.

Do not interpret the result after 20 minutes.

Test results:

POSITIVE - The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE* - The presence of only control line (C) within the result window indicates a negative result.

INVALID - If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

Note: The intensity of color in the test line region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. Please note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

(*Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.)

In-vitro use only. Please note, each box includes 1 x work station and 2x buffer solutions, therefore it can not be split up.

The Healgen Covid-19 Antigen Test (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Healgen Covid-19 Antigen Test (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.

Clinical Evaluation:

Positive Percent Agreement (PPA): 97.3%

Negative Percent Agreement (NPA): 99.6%

Overall Percent Agreement (OPA): 98.9%

Specimen: Nasopharyngeal (NP) Swab

Time to Results: 15 minutes

Shelf Life: usually 24 months from the date of manufacture

Due to the nature of this product, it cannot be returned/exchanged.

This swab test is intended for the rapid detection of COVID-19 - results available within 15 minutes with high accuracy.

Each kit contains everything required to carry out the tests- no additional equipment is needed.
Approved by Public Health England & validated by the UK Government.
Results in 15 minutes.
Each kit includes clear instructions and is easy to use.
This test is not for non-clinical use.

Instructions for Use:

Remove the test cassette from the sealed foil pouch and use it as soon as possible.
Lay device on flat surface and add specimen. With the plastic dropper provided, draw specimen to exceed the specimen line, as shown in the diagram below.
Hold the dropper vertically and transfer drawn specimen into the sample well.
Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well, ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
Wait for the control line to change from blue to a red color.
If, after 2 minutes, the sample has not moved across the test window, add 1 additional drop of sample buffer to the buffer well.
The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

Test Procedure:

1. Specimen Collection

Use the nasopharyngeal swab supplied in the kit

Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx that presents the most secretion under visual inspection.

Swab over the surface of the posterior nasopharynx.

Rotate the swab several times. Withdraw the swab from the nasal cavity.

2. Sample preparation

Insert the test extraction tube into the workstation

Make sure that the tube is standing firm and reaches the bottom of the workstation

Add 0.3 mL (about 10 drops) of the sample extraction buffer into the extraction tube.

Squeeze the tube several times with fingers from outside of the to immerse the swab

Fit the dropper tip with filter on top the extraction tube tightly

Remove the swab. The extracted solution will be used as test sample.

3. Interpretation of Results

Allow the test device, test sample and buffer to equilibrate to room temperature prior to testing

Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

Ensure the nozzle with filter is fitted on to the sample extraction tube tightly.

Reverse the sample extraction tube, and add 4 drops (about 100 μL) of test sample by squeezing the extracted

solution tube into the sample window.

Wait for the colored band(s) to appear. The result should be read in 15 minutes.

Do not interpret the result after 20 minutes.

Test results:

POSITIVE - The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE* - The presence of only control line (C) within the result window indicates a negative result.

In-vitro use only. Please note, each box includes 1 x work station and 2x buffer solutions, therefore it can not be split up.

Clinical Evaluation:

Positive Percent Agreement (PPA): 97.3%

Negative Percent Agreement (NPA): 99.6%

Overall Percent Agreement (OPA): 98.9%

Specimen: Nasopharyngeal (NP) Swab

Time to Results: 15 minutes

Shelf Life: usually 24 months from the date of manufacture

Due to the nature of this product, it cannot be returned/exchanged.

$106.98

Healgen COVID-19 Rapid Antigen Test (20 Tests)—

$106.98

Healgen COVID-19 Rapid Antigen Test (20 Tests)—

$106.98

Description

This swab test is intended for the rapid detection of COVID-19 - results available within 15 minutes with high accuracy.

Each kit contains everything required to carry out the tests- no additional equipment is needed.
Approved by Public Health England & validated by the UK Government.
Results in 15 minutes.
Each kit includes clear instructions and is easy to use.
This test is not for non-clinical use.

Instructions for Use:

Remove the test cassette from the sealed foil pouch and use it as soon as possible.
Lay device on flat surface and add specimen. With the plastic dropper provided, draw specimen to exceed the specimen line, as shown in the diagram below.
Hold the dropper vertically and transfer drawn specimen into the sample well.
Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well, ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
Wait for the control line to change from blue to a red color.
If, after 2 minutes, the sample has not moved across the test window, add 1 additional drop of sample buffer to the buffer well.
The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

Test Procedure:

1. Specimen Collection

Use the nasopharyngeal swab supplied in the kit

Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx that presents the most secretion under visual inspection.

Swab over the surface of the posterior nasopharynx.

Rotate the swab several times. Withdraw the swab from the nasal cavity.

2. Sample preparation

Insert the test extraction tube into the workstation

Make sure that the tube is standing firm and reaches the bottom of the workstation

Add 0.3 mL (about 10 drops) of the sample extraction buffer into the extraction tube.

Squeeze the tube several times with fingers from outside of the to immerse the swab

Fit the dropper tip with filter on top the extraction tube tightly

Remove the swab. The extracted solution will be used as test sample.

3. Interpretation of Results

Allow the test device, test sample and buffer to equilibrate to room temperature prior to testing

Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

Ensure the nozzle with filter is fitted on to the sample extraction tube tightly.

Reverse the sample extraction tube, and add 4 drops (about 100 μL) of test sample by squeezing the extracted

solution tube into the sample window.

Wait for the colored band(s) to appear. The result should be read in 15 minutes.

Do not interpret the result after 20 minutes.

Test results:

POSITIVE - The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE* - The presence of only control line (C) within the result window indicates a negative result.

In-vitro use only. Please note, each box includes 1 x work station and 2x buffer solutions, therefore it can not be split up.

Clinical Evaluation:

Positive Percent Agreement (PPA): 97.3%

Negative Percent Agreement (NPA): 99.6%

Overall Percent Agreement (OPA): 98.9%

Specimen: Nasopharyngeal (NP) Swab

Time to Results: 15 minutes

Shelf Life: usually 24 months from the date of manufacture

Due to the nature of this product, it cannot be returned/exchanged.

Healgen COVID-19 Rapid Antigen Test (20 Tests)

Description

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