Goldsite Auto Antigen Test Rapid COVID-19 Nasal Swab

GOLDSITE
SARS-CoV-2 Antigen Kit
(Colloidal Gold)
Description
A single-use, visually readable in vitro immunochromatographic rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid (N) antigen in human nasal swab specimens.
The results are for SARS-CoV-2 nucleocapsid protein antigen identification. The antigen is usually detectable in nasal swabs during the acute phase of the infection.
The kit uses lateral flow immunoassay technology. To begin the test, a self-collected nasal swab sample is placed in the extraction tube. The prefilled solution in the tube interacts with the sample and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The extracted sample is added to the sample well of the test cartridge.
If the extracted sample contains SARS-CoV-2 antigens, a pink to red line will appear in the Test Line region (T) and a red line will appear in the Procedural Control Line region (C).
The absence of the test line (T) indicates that SARS-CoV-2 antigens are not detected, suggesting that SARS-CoV-2 is not present or is present at very low levels.
Positive results indicate the presence of viral antigens, but correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The detected agent may not be the definitive cause of the disease.
Negative results should be assumed and, if necessary, confirmation with a molecular test for patient management can be performed. Negative results do not rule out COVID-19 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 the patient's recent exposures, medical history, and the presence of clinical signs and symptoms consistent with COVID-19. People who test negative and continue to experience symptoms such as fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow-up care with their doctor or healthcare professional.
The kit is intended for use by non-expert users (self-tests) in a private setting to aid in the rapid diagnosis of COVID-19 infections. Children (at least 2 years old) under the age of 15 must be tested by an adult.
Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals treat patients and control the disease more efficiently and effectively.

How to use
Before starting the test, wash your hands with soap and water or use hand sanitizer. Make sure they are dry before starting the test.
Allow the kit to reach room temperature (15-30°C) before testing. Open the kit and identify the kit components and instructions.

Sample collection
Open the swab pouch from the stick end. Take the swab and, while rotating it, gently insert the swab tip up to 2 cm from the edge of the nostril. Rotate the swab 5 times against the nasal wall. Remove the swab from one nostril and repeat the same procedure in the other nostril, using the same swab.
Do not touch the tip of the swab when handling it.
Children (at least 2 years old) under the age of 15 and people who are unable to test themselves, including the elderly and infirm, should be tested by another adult.
To sample a child, insert the swab into one nostril until resistance is felt. Rotate the swab 5 times against the nasal wall. Remove the swab and repeat the procedure in the other nostril, using the same swab. If the child feels pain, do not continue testing.

Inadequate or inappropriate specimen collection may produce false negative results.

Procedure
Remove the dropper lid from the pre-filled extraction tube. Place and immerse the patient swab in the extraction buffer.
Rotate the swab 5-6 times by squeezing the sides of the tube.
Insert the tube into the hole indicated on the kit box. Make sure the tube is upright and reaches the bottom.
Leave the swab in the extraction tube for 1 minute.
Stir to mix the contents well. Remove the swab by squeezing the sides of the tube. Immediately throw the swab in the trash.
Replace and screw the dropper lid onto the top of the extraction tube. Mix the contents well (by inverting the tube several times).
Open the foil pouch containing the test cartridge. Place the cartridge on a clean, flat and dry surface. Remove the lid from above the dropper lid, invert the extraction tube, then add two drops (approximately 70 mcL) of the well-mixed sample into the sample well of the test strip.
Leave the test cartridge loaded with sample at room temperature for 12 minutes.
After the 12 minute incubation, read the results. Do not interpret results after 15 minutes (from sample addition).

Interpretation of results
Positive: Two lines will appear. A pink-red line in the test line region (T) and a red line in the control line region (C). The test line (T) can be very weak. Any visible pink/red T-line should be considered positive.

Negative: A single line appears in the control line region (C).

Invalid: No red line appears in the control line region (C). Insufficient sample volume, incorrect test procedure are the most likely reasons for control line failure. Collect a new sample and repeat the test with a new kit. If the problem persists, discontinue use of the kit and contact your local distributor.

Warnings
For in vitro diagnostic use.
Read the instructions carefully before starting the test. To get accurate results, you must follow the instructions.
If the package is damaged, the label is not clearly visible, or if the test cartridge has expired, do not use the test.
Keep kits out of the reach of children.
Do not open the test cartridge foil pouch until ready to use.
Do not reuse test cartridges, tubes, or swabs.
Don't eat the desiccant.
Do not interchange or mix components from different kit lots.
Inadequate or inappropriate specimen collection may produce false negative results.
Dispose of kit components and samples in household waste.
The use of gloves is recommended during sampling and testing.
The test is only for the qualitative detection of SARS-CoV-2 antigen in nasal swab specimens.
The test detects both viable (alive) and non-viable SARS-CoV-2. Test performance depends on the amount of virus (antigen) in the specimen and may or may not correlate with viral culture results performed on the same specimen.
A negative test result can occur if the level of antigen in a sample is below the limit of detection of the test.
Failure to follow test procedure, interpretation of results may adversely affect test performance and/or invalidate test results.
False negative results may occur if a sample is improperly collected or handled.
Positive results do not rule out co-infections with other pathogens.
A negative result does not rule out SARS-CoV-2 infection. Negative results should be considered presumptive and may need to be confirmed with a molecular test.
False negative results are more likely after 8 days of symptoms.

storage
Store at 2-30°C, in a dry place and avoid exposure to direct sunlight. Do not freeze any of the kit components.
Unopened cartridges are stable until the expiration date printed on the labels. Once the test cartridge foil pouch is opened, the test should be used within 30 minutes.
Validity with intact packaging: 12 months.

Format
The kit contains:
- 1 test cartridge;
- 1 tampon;
- 1 extraction tube;
- 1 leaflet.