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Acro Rapid Test Saliva COVID-19 Ag

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  • Product Code: MM-AC19AGRT
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 Request Form   The right option to EXPAND TESTING FOR COVID-19 ANTIGENS For patients with suspected active COVID-19 infection. It.. See More

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The right option to EXPAND TESTING FOR COVID-19 ANTIGENS
For patients with suspected active COVID-19 infection.

It requires no equipment and delivers results in 15 minutes, making it a valuable tool for mass testing in decentralized scenarios.

Saliva test

Professional use.

Affordable, portable and scalable option for COVID-19 testing.

It can also be useful to support public health strategies, such as contact tracking and large-scale testing in people with suspected active infection.

To order the tests, you must be a health professional and fill out the form above (members of the Order of Doctors, Nurses, Dentists and Pharmacists).

Then, after everything is validated, you will receive the instructions to proceed with the order.

 

Purchased only in boxes with 20 tests each.

 

Price according to the desired quantity:

(price for each test)
20- 380 tests
(1 - 19 boxes): 6.5 € / Unit.
500 - 975 tests
(20 - 39 boxes): 6,25 € / Unit.
from 1000 tests
(40 boxes): 6,00 € / Unit.

 

 

 

 

 

Additional information

 

Datasheet:

The COVID-19 Rapid Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Antigens present in human oral fluid.
For professional in vitro diagnostics only.


INTENDED USE
The COVID-19 Rapid Antigen Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in oral fluid samples from individuals suspected of having SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.
The results are for the detection of SARS-CoV-2 antigens. An antigen is usually detectable in the upper respiratory samples during the acute stage of the infection. Positive results indicate the presence of viral antigens, but a clinical correlation with the patient's history and other diagnostic information is necessary to determine the status of the infection. Positive results do not exclude bacterial infection or co-infection with other viruses. The detected agent may not be the definitive cause of the disease.


Negative results do not prevent SARS-CoV-2 infection and should not be used as a sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for the treatment of the patient. Negative results should be
considered in the context of a patient's recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19.
The COVID-19 Rapid Antigen Test should be used by trained clinical laboratory personnel.


ABSTRACT
The new coronaviruses belong to the genus β. COVID-19 is an acute respiratory infectious disease. People are usually susceptible. Currently, patients infected with the new coronavirus are the main source of infection; Asymptomatic infected people can also be an infectious source. Based on current epidemiological research, the incubation period is 1 to 14 days, mainly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in some cases.


PRINCIPLE
The COVID-19 Rapid Antigen Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antigens in a human oral fluid sample. The SARS-CoV-2 antibody is coated in the region of the test line. During the test, the sample reacts with the SARS-CoV-2 antibody coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 antibody in the region of the test line. If the sample contains SARS-CoV-2 Antigens, a colored line will appear in the region of the test line as a result. If the sample does not contain antigens for SARS-CoV-2, no colored lines will appear in the region of the test line, indicating a negative result. To serve as a procedural control, a colored line will always appear on the region control line, indicating that the appropriate sample volume has been added and the absorption of the membrane has occurred.


REAGENTS
The test contains anti-SARS-CoV-2 antibody as the capture reagent and anti-SARS-CoV-2 antibody as the detection reagent.


PRECAUTIONS
1. This package leaflet must be read completely before performing the test. Failure to follow instructions in the package leaflet may produce inaccurate test results.
2. For professional in vitro diagnostics only. Do not use after the expiration date.
3. Do not eat, drink or smoke in the area where samples or kits are handled.
4. Do not use the test if the bag is damaged.

5. Handle all samples as if they contain infectious agents. Observe the established precautions against microbiological hazards during the collection, handling, storage and disposal of the patient samples and contents of the used kit.
6. Wear protective clothing, such as lab coats, disposable gloves and eye protection when samples are tested.
7. Wash your hands thoroughly after handling.
8. Make sure that an adequate amount of samples is used for the test. Too much or too little the sample size can lead to deviations in the results.
9. Samples extracted for PCR testing or samples of viral transport medium (VTM) cannot be used for testing.
10. The test used must be discarded in accordance with local regulations.
11. Humidity and temperature can adversely affect results.


STORAGE AND STABILITY

Store in sealed packaging at room temperature or refrigerated (2-30 ° C). The test is stable until the expiration date printed on the package.
The test must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use after the expiration date.


SPECIMEN COLLECTION AND STORAGE

The oral fluid sample must be collected using the collection device provided with the kit. Follow the detailed instructions for use below. No other collection devices should be used with this assay.
The oral fluid collected at any time of the day can be used. Samples should be tested as soon as possible after collection. If the oral fluid is not processed immediately, it is stable for up to 8 hours at room temperature and 24 hours at 2-8 ° C.


MATERIALS


Material Provided

  • Testing devices
  • Collection devices
  • Buffer
  • Information leaflet
  • Procedure card
  • Biosafety bags

Materials needed but not provided

  • Timer
  • Sample container


INSTRUCTIONS FOR USE
Allow the test device, collection device, buffer and / or controls to equilibrate in the room temperature (15-30 ° C) before testing.

Specimen Collection

  • Important: before collecting oral fluid, instruct patients to cough deeply 3 to 5 times, releasing particles from the upper and lower respiratory tract into the patient's oral fluid. Instruct the patient to relax their cheeks and gently massage the cheeks with their fingers for 15-30 seconds, place the tongue against the upper and lower jaws and roots to enrich the oral fluid.
  • ①Remove the collection device and collect Approx. 500μl oral fluid sample.
  • If sufficient oral fluid is not collected, repeat the sample collection steps above.


Specimen extraction

  • ②Mix the buffer (Approx. 500 μl) with the collected oral fluid.
  • Gently stir the mixture for 10 seconds.
  • NOTE: Sample storage after extraction is stable for 2 hours at room temperature or 24 hours at 2-8 ° C.

Test Reaction

  • Remove the test device from the sealed aluminum packaging and use it within an hour. The best results will be obtained if the test is performed immediately after opening the package.
  • ③Add the extracted sample to the test device, wait until the colored lines appear. Read the result in 15 minutes. Do not interpret the result after 20 minutes.
  • Refer to the procedure card for detailed information on the test procedure.


INTERPRETATION OF RESULTS
 

POSITIVE: * Two colored lines appear. One colored line must be in the control region (C) and another colored line must be in the test region (T). Positive result in the test region indicates detection of SARS-COV-2 antigens in the sample.
* NOTE: The color intensity in the test line region (T) will vary based on the amount of SARS-COV-2 Antigen present in the sample. Therefore, any color tone in the test region (T) must be considered positive.


NEGATIVE: A colored line appears in the control region (C). No apparent colored line appears in the region of the test line (T) indicating a test result of the Negative COVID-19 Antigen.
INVALID: The control line does not appear. Insufficient sample volume or incorrect technical procedures are the most likely reasons for failure of the control line. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.


QUALITY CONTROL

Internal Quality Control
Internal procedure controls are included in the test. A colored line appearing in the control region (C) is an internal positive procedural control. It confirms the sufficient and correct sample volume
procedural technique. A clear background is an internal negative procedural control. If the test is working correctly, the background in the result area should be white to light pink and not interfere with the ability to read the test result.


External Quality Control
Positive / negative controls are not included in this kit. However, in accordance with Good Laboratory Practice (GLP), these controls are recommended.1


LIMITATIONS
1. The test procedure and the interpretation of the test result should be followed closely during the test for the presence of SARS-CoV-2 antigens in human oral fluid samples from suspected individuals. For optimal test performance, adequate sample collection is critical. Failure to follow the procedure can give inaccurate results.
2. The performance of the COVID-19 Antigen Rapid Test (Oral Fluid) was assessed using the procedures provided in this package leaflet only. Modifications to these procedures can alter the performance of the test. Samples extracted for PCR tests or viral transport means (VTM) the sample cannot be used for the test.
3. The COVID-19 Antigen Rapid Test (Oral Fluid) is for in vitro diagnostics only. This test should be used for the detection of SARS-CoV-2 antigens in human oral fluid samples as an aid in diagnosing patients with suspected SARS-CoV-2 infection in conjunction with presentation and results of other laboratory tests . Neither the quantitative value nor the rate
The increase in the concentration of SARS-CoV-2 antigens can be determined by this test.
4. The COVID-19 Antigen Rapid Test (Oral Fluid) will only indicate the presence of SARS-CoV-2 Antigens in the sample and should not be used as the sole criterion for the diagnosis of SARS-CoV-2 Infections.

5. The results obtained with the test should be considered with other clinical findings from other tests and laboratory evaluations.
6. If the test result is negative or non-reactive and the clinical symptoms persist. It is recommended to resume the patient sample a few days later and test again or test with a molecular diagnostic device to rule out infection in these individuals.
7. The test will show negative results under the following conditions: The title of the novel coronavirus antigens in the sample is less than the minimum detection limit of the test.
8. Negative results do not exclude SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up tests with a molecular diagnosis should be considered to rule out infection in these individuals.
9. The positive results of COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors.

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