Alpine Biomedicals Covid 19 Rapid Antigen Test Kit

Alpine Biomedicals Covid 19 Rapid Antigen Test Kit
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the primary source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhoea are found in a few cases.

Test Principle:
Coronaviruses are enveloped RNA viruses distributed broadly among humans, birds and other mammals that cause respiratory, enteric, hepatic, and neurologic diseases. Alpine One-Step COVID-19 Antigen test is an antigen-capture immunochromatographic assay, detecting the presence of COVID 19 viral nucleoprotein antigen in the nasal swab, nasopharyngeal swab sample. This assay utilizes the chemical extraction of viral antigens followed by solid-phase immunoassay technology to detect extracted antigen COVID-19 Monoclonal antibodies specifically against COVID-19 antigen are conjugated with colloidal gold, deposited on the conjugate pad, and immobilized on the Test Zone of the nitrocellulose membrane.
When a simple is added, the gold-antibody conjugate is rehydrated, and the COVID-19 antigen, if any in the sample, will interact with the gold conjugated antibodies. The antigen antibody-gold complex will migrate towards the test window until the Test Zone, where they will be captured by immobilized antibodies, forming a visible pink line (Test band) indicative of a positive result. If COVID-19 antigen is absent in the sample, no pink line will appear in the Test Zone (T). To serve as internal process control, a control band was designed to indicate that the test is performed properly.

Uses:
This kit is used to determine whether an individual has an active Covid-19 infection.

Product Specification and Features:

• The test can determine if you have an active COVID-19 infection and provides test results in just 15-20 minutes

• The results, along with other information, can help your healthcare provider make informed decisions about your treatment

• You can help limit the spread of COVID-19 by knowing your infection status and taking appropriate social distancing measures

• Easy, self-use nasal swab for sample collection

Kit contents:

• Nasopharyngeal swab

• Prefiled Antigen extraction buffer tube

• Test card

• Instruction for use

Directions For Use:
Specimen collection and preparation-
Nasal Swab:

• Let the patient's head relax naturally, and slowly rotate the swab against the wall of the nostril into the patient's nostril to the nasal palate, and then slowly remove it while wiping

• Using the same swab, wipe the other nostril in the same way; place the swab specimen in the extraction tube with the extraction solution added in advance, rotate the swab for about 10 seconds and press the swab head against the tube wall to release the swab antigen

Test procedure:

• Open the package and take out the test card

• Place the prefilled buffer extraction tube on the workbench

• Put the swab specimen into the extraction tube, rotate the swab for about 10 seconds, and press the swab head against the tube wall to release the antigen in the swab

• Squeeze the swab over the head to remove the swab so as to remove as much liquid as possible from the swab. Dispose of swabs according to biohazard waste disposal method

• Install the nozzle on the extraction tube, put 2 (two) drops into the specimen hole of the test card, and start the timer

• Read the results within 15 minutes. Strong positive results can be reported within 15 minutes, however, negative results must be reported after 15 minutes, and the results after 20 minutes are no longer valid

Interpretation of results:
Negative:

• If only the C line is present, the absence of burgundy colour in the T line indicates that no Coronavirus antigen is detected. The result is negative

Positive:

• In addition to the presence of the C-line, if T line is developed, the test indicates the presence of Coronavirus antigen has been detected

• The result is positive samples with reactive results should be confirmed with alternative testing method(s) and clinical samples with reactive results should be confirmed with alternative testing
  method(s) and clinical findings before a positive determination is made

Invalid:

• If no C line is developed, the assay is invalid regardless of the burgundy colour in the test line

Safety Information:

• Read the instructions carefully before using the kit, and strictly control the reaction time. If you do not follow the instructions, you will get inaccurate results

• The specimen shall be tested in a laboratory with certain conditions. All specimens and materials during testing should be handled in accordance with the laboratory practice for infectious diseases

• Guard against moisture, do not open the aluminium platinum bag before it is ready for testing

• Do not use the aluminium foil bag when it is damaged or the test card is damp

• Please use it within the validity period

• Balance all reagents and specimens to room temperature (15-30 ) before use

• Do not replace the components in this kit with components in other kits

• Do not dilute the specimen for testing, otherwise, you may get inaccurate results

• The kit shall be stored in strict accordance with the conditions specified in this manual. Please do not store the kit under freezing conditions

• The test methods and results must be interpreted in strict accordance with this specification

• Negative results will occur with this kit if the novel coronavirus antigen titer in the specimen falls. below the minimum detection limit for this kit

• Do not smoke, drink or eat in areas where specimens or kit reagents are being handled

• Dispose of all specimens and materials used to perform the test as biohazardous waste

• Do not perform the test in a room with strong airflow, i.e. an electric fan or strong air conditioning

Limitations of the test:

• This reagent is only used for in vitro diagnosis

• This reagent is only used to detect human nasopharyngeal swab extracts

• The results of other specimens may be wrong. coronavirus antigen in the specimen

• This reagent is only used for qualitative detection and cannot indicate the level of novel

• This reagent is only a clinical auxiliary diagnostic tool. If the result is positive, it is recommended to use other methods for further examination in time and the doctor's diagnosis shall prevail

• A negative result may occur if the level of extracted antigen in a specimen is below the sensitivity of the test or if a poor-quality specimen is obtained

• A negative result may occur if the concentration of antigen in a specimen is below the detection limit of the test or if the specimen was collected or transported improperly, therefore a negative test result does not eliminate the possibility of Covid-19 infection and should be confirmed by viral culture or a molecular assay or ELISA

• For more accuracy of immune status additional follow up testing using other laboratory methods is recommended

Frequently Asked Questions FAQs:

Q. What is an antigen?
Antigens are proteins that are part of the COVID-19 virus. If the test detects antigens in your swab sample, it means that the COVID-19 virus is present in your body.

Q. Will this test hurt?
The nasal swab may cause slight discomfort. It is important to follow the nasal swab collection steps as indicated in the procedure. Discomfort may occur if the swab is inserted beyond the recommended depth. If painful, slightly withdraw the swab to finish the sample collection process.

Q. Can this test be used on children?
The test can be used for all ages. Children under 14 years old should be supported by an adult.

Q. Will this test tell me if I have been infected with COVID-19 in the past?
No, this is an antigen test that only detects an active infection. Antibody tests can detect past infections.

Q. Does the product expire?
The test has an expiration date printed on the box, and should not be used after that date.

Q. Can I use my own swab or other swabs?
No. You can only use the components included in the test kit.

Q. Can I use this test more than once?
No. Each test can only be used once.

Q. How do I dispose of a used test?
Place the swab, tube, and test device into the included disposal bag. Seal the bag tightly. Throw away the bag in a waste bin.

Q. What does it mean if I have a positive result?
A positive test result means that proteins of the virus that causes COVID-19 have been found in your nasal swab sample. It is likely that you will need to perform self-isolation at home to prevent the spread of Covid-19. A positive result does not rule out coinfection with other pathogens. Please follow local guidelines for social distancing to limit the spread of the virus and contact your doctor or local health department immediately.

Q. What does it mean if I have a negative result?
A negative test result means that it is unlikely that you have COVID-19 at the time of testing. The test did not detect any antigens in your nasal swab sample, but it is possible that your test gave a false-negative test result. False-negative test results can be caused by several factors: The amount of antigen in the swab sample may decrease over the duration of the infection. The test may be negative before you develop symptoms. The test was not performed per the instructions. Specimen collection, extraction or transport was not performed correctly.

Q. I'm feeling unwell but my test is negative. What should I do?
If symptoms continue and the rapid antigen test results are negative, individuals should immediately be tested by RT-PCR per ICMR Advisory, as the coronavirus may not be detectable in the very early phases of infection. You are also advised to continue following local guidelines for self-isolation and consult your doctor.

Q. Is the test authorized for home use?
This test is authorized for non-prescription home use with self-collected nasal swab specimens from individuals aged 18 years and older or with adult-collected nasal swab samples from individuals aged two years or older.

Visit Ministry of Health & Family Welfare, Government of India https://www.mohfw.gov.in