Humasis COVID-19 Ag Test Kit (Box of 25 Tests)

DESCRIPTION

The Humasis COVID-19 Ag Test is a rapid in-vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swab specimens from individuals suspected of COVID-19. This rapid antigen test allows quick screening and identification of suspected SARS-CoV-2 cases in the community. It can be performed at home with high accuracy. Positive or negative results will determine the need for confirmatory testing.

PRODUCT FEATURES – HUMASIS COVID-19 Ag TEST

• Simple procedure – can be self-administered at home
• Fast results in approximately 15 minutes
• High sensitivity and accuracy
• Storage at room temperature (2–30 °C)
• Shelf life: 18 months
• Manufacturer: Humasis Co., Ltd., South Korea
• Approved by Vietnam Ministry of Health (License No. 5044/BYT-TB-CT)

According to the evaluation report from the National Institute for Control of Vaccines and Biologicals (NICVB), the Humasis COVID-19 Ag Test achieves:

• Sensitivity: up to 93.33%
• Specificity and accuracy: 100%

TESTING PROCEDURE

1. Use the provided sterile swab to collect a nasopharyngeal sample. Insert the swab into one nostril until resistance is felt at the posterior nasopharynx. Rotate the swab approximately 5 times for several seconds, then slowly withdraw it. (This step is critical – adequate nasopharyngeal secretion collection is essential for accurate results.)
2. Insert the swab into the extraction tube and stir repeatedly to release the sample into the buffer solution. While removing the swab, squeeze the tube to extract as much liquid as possible. Attach the filter nozzle to the extraction tube.
3. Dispense exactly 3 drops of the extracted solution into the sample well of the test cassette.
4. Read the result within 15 minutes after adding the sample.

IMPORTANT NOTES

• Store the kit at 2–30 °C. Kits may be kept in the refrigerator, but must be brought to room temperature before use.
• Once the individual pouch is opened, the test must be used within 1 hour. Highest accuracy is achieved when the test is performed immediately after opening.
• Proper nasopharyngeal swab technique is the most important factor for accurate results: insert the swab deeply until it touches the posterior nasopharyngeal wall and rotate slowly 5 times.

RESULT INTERPRETATION

The test cassette has two marking zones: C (Control line) and T (Test line)

• Negative: Only one line appears at C
• Positive: Two lines appear at C and T
• Invalid: No line at C, or any other pattern → repeat with a new test cassette

Notes:

• A negative result is presumptive. Confirmatory molecular (RT-PCR) testing is recommended for definitive diagnosis.
• Results read before 15 minutes or after 20 minutes may be inaccurate.

KIT CONTENTS (1 box = 25 individually packed tests)

Each individual test includes:

• 1 Test cassette
• 1 Filter nozzle
• 1 Pre-filled extraction tube with buffer
• 1 Sterile nasopharyngeal swab
• Instruction leaflet