Information
|Qualitative |Visually read results in 15 minutes |Specimen: Direct Nasopharyngeal Swab
Description
Healgen Rapid Covid-19 Antigen Self Test Kit is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19 by their healthcare provider, within 10 days of symptom onset and asymptomatic individuals. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. Contents: 1 test cassette, 1 sterile swab, 1 extraction tube with buffer and tip, 1 procedure card, 1 instructions for use. The device should never be frozen. If refrigerated, allow the test kit components to reach room temperature before use.
BENEFITS
|Portable |Easy to use |Point-Of-Care tests deliver results on-site in 15 minutes |Facilitates patient treatment decisions quickly |Very high sensitivity and specificity |Helps prevent outbreaks in the workplace
HOW TO USE
|Insert the swab into one nostril of the patient. The swab tip should be inserted up to 2-4 cm until resistance is met. |Roll the swab 5 times along the mucosa inside the nostril. Using the same swab, repeat this process for the other nostril. |Withdraw the swab from nasal cavity. |Insert the test extraction tube into the hole on the kit as marked. |Tear off the sealing film on the extraction tube gently to avoid spilling out the liquid. |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 buffer for 1 minute. Squeeze the tube several times from the outside to immerse the swab. Remove the swab. |Just prior to testing, remove the test device from the sealed pouch and lay it on a flat surface |Push the nozzle which contains the filter onto the extraction tube |Ensure the nozzle has a tight fit |Hold the extraction tube vertically and add 4 drops of test sample solution into the sample well |Start the timer |Read the results at 15 minutes. Do not interpret the result after 20 minutes |Interpretation: Presence of two lines as control (C) and test line (T) within the result window indicates a positive result |Presence of only control (C) within the result window indicates a negative result |If the control line (C) is not visible within the result window after performing the test, the result is considered as invalid (Recommended that the specimen be re-tested using a new test) |Intensity of colour in the test line region (T) may vary depending on the concentration of analyses present in the specimen. Therefore, any shade of colour in the test line region (T) should be considered as positive |Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure. |Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
