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TEST ANTIGENICO RAPIDO COVID-19 STRONGSTEP AUTODIAGNOSTICO DETERMINAZIONE QUALITATIVA ANTIGENI SARS-COV-2 IN TAMPONI NASALI/OROF

  • PHARMABIO Srl
  • 982683310
  • 6973181855698

Rapid immunochromatographic test for the detection of SARS-CoV-2 virus nucleocapsid protein antigen in human nasal / oropharyngeal swab or saliva collected from asymptomatic or symptomatic individuals suspected of being infected with COVID-19 within the first five days of appearance symptoms.

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TEST ANTIGENICO RAPIDO COVID-19 STRONGSTEP AUTODIAGNOSTICO DETERMINAZIONE QUALITATIVA ANTIGENI SARS-COV-2 IN TAMPONI NASALI/OROF

StrongStep

SARS-CoV-2 Antigen Rapid Test

Description
Rapid immunochromatographic test for the detection of SARS-CoV-2 virus nucleocapsid protein antigen in human nasal / oropharyngeal swab or saliva collected from asymptomatic or symptomatic individuals suspected of being infected with COVID-19 within the first five days of appearance symptoms.
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 no SARS-CoV-2 antigens are present in the specimen, no red line will form in the Test Zone (T). The streptavidin conjugate will continue to migrate on its own until it is captured in the Control Zone (C) by biotin-BSA which aggregates into a blue line, indicating the validity of the test.
The test is used as an aid in diagnosing COVID-19. It is designed to be used for infection screening and auxiliary diagnosis in symptomatic and asymptomatic people.

How to use
Collection and storage of samples
An anterior nasal swab sample can be collected by a doctor or an individual who performs a self-swab.
The collection of samples from children under the age of 12 must be performed by a physician.
Children between the ages of 12 and 17 must be under adult supervision if they do the anterior nasal swab on their own.
Adults 18 years of age and older can do the anterior nasal swab on their own.
Follow local guidelines for children's specimen collection.

1. Nasal Swab Sample: Insert a swab into a patient's nostril. The tip of the swab should be inserted up to 2.5 cm (1 inch) from the edge of the nostril. Rotate the swab 5 times along the mucosa inside the nostril to ensure 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 passages. Pull the swab out of the nasal cavity and insert the anterior end of the swab into the extraction tube, touch the bottom of the tube and break the swab at the point of rupture, allow the swab tip to dip into the reagent.

2. Oropharyngeal Swab Sample: Ask the patient to open their mouth and press their tongue with a tongue depressor, if necessary. Insert a swab into the oropharynx and scrape the left and right pharyngeal mucosa twice. Remove the swab from the mouth and insert the front end of the swab into the extraction tube, touch the bottom of the tube break the swab at the point of rupture, allow the tip of the swab to dip into the reagent.
To obtain a sufficient amount of sample, it is recommended to use two or more swabs to collect different sample sites and extract all of the sampled swab into the same tube.
Use the swab provided in the kit, alternative swabs can adversely affect the performance of the assay. Users should check the tampon before using it.

3. Saliva sample: Install the saliva collection funnel on the tube, spit the saliva into the tube through the saliva collection funnel until the saliva reaches the position of the saliva collection and filling line (0.5 ml), then remove the saliva collection funnel.

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

Procedure
Bring test devices, specimens, buffer and / or controls to room temperature (15-30 ° C) before use.
Place the collected sample extraction tube in the designated area of the workstation. Add 20 drops of Reagent Solution to the Extraction Tube. Mix the solution by pressing the sample firmly against the side of the tube at least ten times (while immersed). The best results are obtained when the sample is mixed into the solution. Allow the sample to soak in the solution reagent for one minute before the next step.
Extracted samples can be stored at room temperature for 30 minutes without affecting the test result.
Remove the test device from its sealed pouch and place it on a clean, flat surface. Label the device with patient or control identification. For best results, the test should be performed within 30 minutes.
Add 3 drops (approximately 100 μL) of the extracted sample from the Extraction Tube to the round sample well on the Test Device.
Avoid trapping air bubbles in the sample well (S) and do not drop any solution into the viewing window.
Once the test starts working, you will see the color move 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 the results
- Positive result: Two colored bands appear within 15 minutes. A blue band appears in the Control Zone (C) and another red band appears in the Test Zone (T). The test result is positive and valid. No matter how faint the red band appears in the Test Zone (T), the test result must be considered positive.
- Negative result: A blue band appears in the Control Zone (C) within 15 minutes. No red bands appear in the Test Zone (T). The test result is negative and valid.
- Invalid result: No blue bands appear in the Control Zone (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 and self-diagnostic use only.
Read the instructions carefully before performing the test.
This product does not contain materials of human origin.
Do not use the contents of the kit after the expiration date.
Treat all specimens as potentially infectious.
Follow standard laboratory procedure and biosafety guidelines for handling and disposal of potentially infectious material. Once the analysis procedure is complete, dispose of the samples after sterilizing them in an autoclave at 121 ° C for at least 20 minutes. Alternatively, they can 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 testing.
Wear gloves throughout the entire procedure.
It is recommended to use the SARS-CoV-2 Rapid Antigen Detection System Bio Liming System to protect the population and prevent infection.

storage
Store at 2 ° C to 30 ° C.
Validity for intact packaging: 2 years.

Format
The kit contains:
- Test device packaged in a sealed pouch
- Solution reagent vial
- Extraction pad
- Pack of buffer
- Funnel for the collection of saliva
- Workstation
- Package leaflet

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