Rapid antigen test covid-19 strongstep self-diagnostic qualitative determination of sars-cov-2 antigens in nasal/oropharyngeal/saliva swabs by immunochromatography

Description
Rapid immunochromatographic test for the detection of SARS-CoV-2 virus nucleocapsid protein antigen in nasal/nasopharyngeal/saliva swab collected from asymptomatic or symptomatic individuals suspected of being infected with COVID-19 within the first five days of symptom onset.
Latex-conjugated antibodies (Latex-Ab) corresponding to SARS-CoV-2 are dry immobilized at the end of the nitrocellulose membrane strip. SARS-CoV-2 antibodies are bound to the Test Zone (T) and biotin-BSA is bound to the Control Zone (C).
When the sample is added, it migrates by capillary diffusion rehydrating the latex conjugate.
If present in the sample, SARS-CoV-2 antigens will bind to the conjugated antibodies to form particles. These particles will continue to migrate along the strip to the Test Zone (T) where they are captured by SARS-CoV-2 antibodies generating a visible red line.
If there are no SARS-CoV-2 antigens in the sample, no red line forms in the Test Region (T).
The streptavidin conjugate will continue to migrate on its own until it is captured in the Control Region (C) by biotin-BSA which aggregates into a blue line, indicating the validity of the test.
The test is used as an aid in the diagnosis of COVID-19. It is designed to be used for infection screening and auxiliary diagnosis in symptomatic and asymptomatic people.

How to use
Sample collection and storage
1. Nasal Swab Sample: Insert a swab into one nostril of the patient. The tip of the swab should be inserted within 2.5 cm (1 inch) of the edge of the nostril. Rotate the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected. Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both nasal cavities.

2. Nasopharyngeal Swab Sample: Insert a swab into the patient's nose, parallel to the nasal floor and septum. Continue to insert the swab until resistance is felt, indicating contact with the nasopharynx. Once the swab is in the patient's nasopharynx, it is recommended to gently rotate the swab, allowing it to complete two full rotations, to allow the secretions in the nasopharynx to be absorbed. Repeat the same procedure in the other nostril.

3. Saliva sample: Remove the seal from the tube containing the extraction fluid. Install the saliva collection funnel on the tube and spit the saliva into the tube through the funnel. Once finished, remove the funnel from the tube.

It is recommended that samples be processed as soon as possible after collection.
Samples may be stored in containers for up to 1 hour at room temperature (15°C to 30°C) or up to 24 hours if refrigerated (2°C to 8°C) prior to processing.

Procedure
Bring test devices, specimens, swab and/or controls to room temperature (15-30°C) before use.
Remove the seal from the tube containing the extraction fluid. Insert the sample into the tube and mix the solution vigorously by rotating the swab vigorously against the side of the tube at least ten times (while immersed). The best results are obtained when the sample is mixed vigorously into the solution.
Leave the swab in the extraction solution for one minute before the next step. Press the walls of the tube with your fingers to release as much sample as possible into the extraction solution. Break the swab shaft and remove the excess, leaving the tip inside the tube. Close the tube with the dropper cap and dispose of the swab in an appropriate biohazardous waste container.
Extracted samples can be stored at room temperature for 30 minutes without altering the test result.
Remove the test device from the sealed pouch and place it on a clean, flat surface. Label the device with the patient or control identification.
For best results, the test should be performed within 30 minutes.
Add 3 drops (approximately 100 mcL) of sample extracted from the extraction tube to the round sample well on the analysis device.
Avoid trapping air bubbles in the sample well (S) and do not drop any solution into the observation window.
Once the test begins to work, you will see the color moving across the membrane. Wait for the colored bands to appear. The result should be read visually at 15 minutes. Do not interpret the result after 30 minutes.

Interpretation of results
- Positive Result: Two colored bands appear within 15 minutes. A blue band appears in the Control Region (C) and another red band appears in the Test Region (T). The test result is positive and valid. No matter how faint the red band appears in the Test Region (T), the test result should be considered positive.

- Negative Result: A blue band appears in the Control Region (C) within 15 minutes. No red band appears in the Test Region (T). The test result is negative and valid.

- Invalid Result: No blue band appears in the Control Region (C) within 15 minutes. The test result is invalid. Repeat the test with a new test device.

Warnings
This kit is for in vitro diagnostic use only.
Read the instructions carefully before performing the test.
This product does not contain any human-derived materials.
Do not use the contents of the kit after the expiration date.
Treat all specimens as potentially infectious.
Follow standard laboratory procedures and biosafety guidelines for handling and disposing of potentially infectious material. Once the testing procedure is completed, discard specimens after autoclaving at 121°C for at least 20 minutes. Alternatively, they may be treated with 0.5% sodium hypochlorite four hours prior to disposal.
Do not pipette the reagent by mouth and do not smoke or eat while performing the tests.
Wear gloves throughout the procedure.
It is recommended to use the Liming Bio System device for the Rapid Detection of SARS-CoV-2 Antigen to protect the population and prevent infections.
The kit is intended to be used for the qualitative detection of SARS-CoV-2 antigens in nasal/nasopharyngeal/saliva swabs.
This test detects both viable (alive) and non-viable SARS-CoV-2. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.
A negative test result may occur if the antigen level in a sample is below the test's detection limit or if the sample was improperly collected or transported.
Failure to follow the test procedure may adversely affect the performance of the test and/or invalidate the result.
Test results should be correlated with the clinical history, epidemiological data, and other data available to the physician treating the patient.
Positive test results do not exclude co-infections with other pathogens.
Negative test results are not intended to exclude other non-SARS viral or bacterial infections. Negative results in patients with symptom onset beyond seven days should be treated as presumptive and confirmed with an approved molecular test, if necessary, for clinical management, including infection control.
Positive and negative predictive values ​​are highly dependent on prevalence rates. Positive test results are more likely to represent false-positive results during periods of little or no SARS-CoV-2 activity when disease prevalence is low. False-negative results are more likely when disease prevalence caused by SARS-CoV-2 is high.
Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid modifications in the target epitope region.
The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals.
The amount of antigen in a sample may decrease as the duration of illness increases. Samples collected after the 5th day of illness are more likely to be negative than an RT-PCR test. The sensitivity of the test after the first five days of symptom onset has been shown to decrease compared to an RT-PCR test.
It is not recommended to use VTM (Virus Transportation Media) samples for this test.
The test has been validated with the swabs provided in the kit. The use of alternative swabs may cause erroneous results.
Keep out of reach of children.
Positive results indicate that viral antigens have been detected in the sample taken, please self-isolate and inform your family doctor promptly.

Conservation
Store at 2°C to 30°C.
Validity with intact packaging: 24 months.

Format
The kit contains:
- 1 Test device packaged in a sealed pouch
- 1 Extraction tube with extraction solution
- 1 Pack of swab
- 1 Funnel for collecting saliva
- 1 Workstation
- 1 leaflet

Code 500200