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COVID-19 rapid test for home use (nasal swab)

A rapid test for the qualitative detection of novel coronavirus antigens in human nasal swab specimens. It is intended for personal use without prior professional training as a rapid test method for novel coronavirus infection. It is suitable for users over 15 years old. Users under 15 years of age should be tested with assistance of adults. Both symptomatic and asymptomatic infections can be tested. The test results can be interpreted quickly in 15 minutes. Accuracy = 99.04% Sensitivity = 96.4% Specificity = 99.8%

Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients.

Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Important! Negative test results do not completely rule out being infected with SARS-CoV-2. If you continue to suspect any symptoms, further testing is strongly recommended. Call the family doctor hotline 1220. Test principle: This product uses the double antibody sandwich method to detect the SARS-CoV-2 N protein. When the sample contains the coronavirus antigen, both the test line (C) and the control line (T) will appear, and the result will be positive. When the sample does not contain the coronavirus antigen or no coronavirus antigen is detected, the test line (T) will not appear, only control line (C) will appear. Specimen collection and preparation: Allow test device extraction reagent and specimens to equilibrate to room temperature (15 ~ 30 ℃) prior to testing. Please keep the temperature at 15 ~ 30 ℃ and the humidity at 20%-80% during the whole test. Blow your nose several times before collecting the specimen. Clean your hands and make sure they are dry before starting the test.
  1. Open the package and take out the test device. Identify the observation window and specimen well (S). The test should be performed within one hour of opening the package.
  2. Unscrew the cap of the extraction tube counterclockwise.
  3. Press on the pre-drilled circle on the outer box and make a hole. Then insert the bottom of the antigen extraction tube into the hole.
  4. Remove the sterilized swab from its packaging.
  5. Relax your head naturally. Carefully insert the swab into the nostril. The tip of the swab should be inserted up to 2 cm until resistance is met.
  6. Roll the swab firmly around the inside of the nostril, making 5 complete circles. Using the same swab, repeat this process for the other nostril to ensure an adequate amount of specimen is collected.
  7. Withdraw the swab from the nasal cavity.
Test procedure:
  1. Put the swab specimen into the extraction tube, rotate the swab for about 10 seconds, and press the swab head against the tube wall 3 times to release the antigen in the swab.
  2. Tighten the cap of the extraction tube clockwise.
  3. Unscrew the small white cap on top of the extraction tube.
  4. Hold the extraction tube vertically and add two drops of the test specimens into the specimen well (S). Start the timer.
  5. Read result at 15 minutes. Do not read results after 30 minutes.
  6. Please put all used materials in the enclosed collection bag for proper disposal. The test kit can be disposed of with normal household waste in compliance with the applicable local regulations.
Interpretation of test results:
  1. POSITIVE: If both the control line (C) and the test line (T) appear, it indicates that SARS-CoV-2 antigen has been detected and the result is positive.
    • Currently, there is a suspected infection with COVID-19.
    • Contact your doctor or local health department immediately.
    • Comply with the local self-isolation guidelines.
    • Perform a PCR test for confirmation.
  2. NEGATIVE: If there is only a control line (C) and the test line (T) is colorless, it indicates that SARS-CoV-2 antigen has not been detected and the result is negative. Continue to comply with all applicable rules regarding contacts and protective measures. Even if the test is negative, there may be an infection. In case of doubt, repeat the test after 1-2 days because the coronavirus cannot be accurately detected at all stages of infection.
  3. INVALID: If the control line (C) is not observed, the test is considered to be invalid whether the test line (T) is visible or not. A new test needs to be performed using a new test device. If the test result is invalid, it may be caused by incorrect test procedures. Please repeat the test. If the test result is still invalid, please contact your doctor or COVID-19 testing center.
Precautions:
  1. This test kit is only used for in vitro diagnosis.
  2. This test kit is only used to detect coronavirus antigen in human nasal swab specimens. The results of other specimens may be wrong.
  3. This test kit is only used for qualitative detection and cannot indicate the quantity of SARS-CoV-2 antigen in the specimen.
  4. This test kit is only a clinical auxiliary diagnostic tool. If the result is positive, it is recommended to use other methods for further examination and the doctor’s diagnosis shall prevail.
  5. This test does not determine the aetiology of the respiratory infection caused by micro-organisms other than the SARS-CoV-2 virus.
  6. This test can detect both the viable and the non-viable SARS-CoV-2 virus. The accuracy of the test depends on the quality of the swab sample. False negative results may be given following poor sampling.
  7. Any failure to follow the test procedure may negatively impact the performance of the test and/or invalidate the test result.
  8. If the result of the test is negative, yet clinical symptoms persist, it is advised that you carry out additional tests using other clinical methods. A negative result at no time rules out the presence of antigens of the SARS-CoV-2 virus in the sample, as they may be present but at a level inferior to the minimum detection level of the test, or if the sample has been collected incorrectly.
  9. A negative result does not rule out infection with the SARS-CoV-2 virus, particularly in people who have come into contact with the virus. Follow-up tests with molecular diagnostics should be scheduled to rule out infection in these people. Persons who show symptoms of the disease but have a negative result until infection is ruled out should follow country-specific restrictions.
  10. This test is not a substitute for a medical consultation, or for the result of a biological analysis carried out in a medical analysis laboratory.
  11. Positive test results do not exclude the possibility of co-infections of other pathogens.
Store at 4℃~30℃, and it is valid for 24 months. After the aluminum foil bag is unsealed, the test device should be used as soon as possible and within one hour (15 ~ 30℃), humidity ≤80%).
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Nasal swab COVID-19 rapid test kit GREENSPRING

Green Spring SARS-CoV-2 Antigen Rapid Test Kit for home and professional use.
The rapid test can only be administered by qualified medical personnel. For professional use only. Quick and easy: The Antigen Rapid Test Kit is used for the fast and efficient qualitative detection of the SARS-CoV-2 antigen in swab samples taken from either the nasal cavity, the oropharynx or nasopharynx. You will get trustworthy results in just 15 minutes. Contents: 1 x SARS-CoV-2 antigen rapid test device 1 x extraction reagent (a small package containing the buffer) 1 x swab (a long Q-tip) 1 x extraction tube 1 x instruction manual Test procedure: Carefully read the instructions prior to using the rapid test kit! Perform the test no later than 30 minutes after taking the swab out of its packaging. The test kit should be stored at a temperature between 10°C – 30°C, at a humidity level less than 70%. According to the manufacturer, the test kit is valid for 12 months. 1. Take the swab out of its packaging. 2. Hold the extraction tube in one hand or place it on a flat surface. Remove the cap by twisting it off. Add one whole extraction buffer package into the extraction tube. 3. There are three possible methods for conducting the test. Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients. Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit. Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit. Nasopharyngeal swab (accuracy 99.35%, sensitivity, 98%, specificity 100%): 1. Slightly tilt the patient’s head back. 2. Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. The swab should reach a depth equal to the distance from the nostrils to the outer opening of the ear. 3. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. 4. Slowly remove the swab while rotating it between the fingers. Nasal swab (from the nasal cavity) (accuracy 98,48%, sensitivity 96,80%, specificity 100%): 1. Gently insert the swab into the nostril, so that the tip of the swab reaches no more than 2,5 cm deep from the entrance of the nostril. 2. Rotate the swab against the nasal wall to collect both the nasal mucus and cellular material. 3. Slowly remove the swab while rotating it between the fingers. Oropharyngeal swab (from the back of the throat): 1. Ask the patient to open the oral cavity as much as possible by making an “aah” sound. This will expose the tonsils. 2. While inserting the swab, avoid contact with the tongue, teeth, cheeks or palate. After reaching the oropharynx, rub the swab on the posterior wall back and forth at least three times. 3. Swirl the swab tip in the buffer fluid inside the extraction tube, pushing into the wall and bottom of the extraction tube at least three times. Then squeeze out the swab by squeezing the extraction tube with your fingers. Use the extracted fluid for the test. 4. Cover the extraction tube tightly with the dropping nozzle cap. Take the test device out of its packaging. Hold the extraction tube vertically and squeeze three drops of fluid slowly into the specimen well of the test device (S). Start the timer. Negative test results do not completely rule out the existence of SARS-CoV-2 particles in the sample! Disposal: Dispose of the test components inside a shatterproof, waterproof and tightly sealed container.
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Saliva antigen rapid test kit DeepBlue

A rapid test for the qualitative detection of novel coronavirus antigens in human saliva.
For professional use only. The saliva test is a convenient and safe method for assessing the risk of being infected with the novel coronavirus COVID-19. This helps you decide how to proceed regarding immediate treatment. The test results can be interpreted quickly in 20 minutes. Accuracy = 99.22% Sensitivity = 97.1% Specificity = 99.8% Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients. Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit. Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit. Important! Negative test results do not completely rule out being infected with SARS-CoV-2. If you continue to suspect any symptoms, further testing is strongly recommended. Call the family doctor hotline 1220. Test principle: This kit uses the double antibody-sandwich method to detect SARS-CoV-2 antigens. When an appropriate amount of specimen is added to the specimen well(s) of the test device, the specimen will move forward along the test device.  If the specimen contains an antigen, the antigen binds to mouse anti-SARS-CoV-2 N protein monoclonal antibody labeled with colloidal gold on the binding pad. Then, the immune complex forms a sandwich complex with another coated mouse anti- SARS-CoV-2 N protein monoclonal antibody on the test line. A visible colored line will show up, which indicates that the SARS-CoV-2 antigen is positive. The test device also contains a quality control line, regardless of whether there is a test line, the red quality control line should appear. If the quality control line does not appear, it indicates that the test result is invalid and need to do the test again. Specimen collection and preparation: Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Collected specimens may be stored at 2-8℃ for no more than 24 hours. Store at -70 ℃ for a long time, but avoid repeated freeze-thaw cycles.
  1. Before collecting oral fluid relax your cheeks and gently massage cheeks with fingers for 15-30s.
  2. Gently spit oral fluid into collection container, try to collect oral fluid without bubbles.
  3. Tear off the sealing film on the antigen extraction tube.
  4. Use a dropper to draw the oral fluid and transfer 2-3 drops of oral fluid to the antigen extraction tube.
  5. Insert a dropper tip into the extraction tube tightly.
  6. Gently shake the extraction bottle for 10 seconds, to make sure the sample is well mixed.
Test procedure:
  1. Read the instructions carefully before use and allow test device, extraction reagent and specimens to equilibrate to room temperature prior to testing.
  2. Open the package and take out the test device.
  3. Hold the extraction tube vertically and add two drops of the test specimens into the specimen well (s). Start the timer.
  4. Interpret the results within 20 minutes. The results after 30 minutes are no longer valid.
Interpretation of test results:
  1. Negative result: if there is only a quality control line C, the detection line T is colorless, indicating that SARS-CoV-2 antigen has not been detected and the result is negative.
  2. Positive result: if both the quality control line C and the detection line T appear, indicating that SARS-CoV-2 antigen has been detected and the result is positive.
  3. Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line T (as shown in the  figure below), and the test shall be conducted again.
Precautions:
  1. Read the instructions carefully before using the kit, and strictly adhere to the reaction time. If you do not follow the instructions, you will get inaccurate results.
  2. Do not eat, drink, chew gum, smoke or vape for at least 30 minutes before collecting saliva.
  3. Guard against moisture, do not open the aluminum platinum bag before it is ready for testing. Do not use it if the aluminum foil bag is damaged or the test device is damp.
  4. Please use it within the validity period.
  5. Balance all reagents and specimens to room temperature (15 ~ 30 ℃) before use.
  6. Do not replace the components in this kit with components from other kits.
  7. Do not dilute the specimen when testing, otherwise you may get inaccurate results.
  8. The kit shall be stored in strict accordance with the conditions specified in this manual. Please do not store the kit under freezing conditions.
  9. The test methods and results must be interpreted in strict accordance with this specification.
  10. Negative results may occur if the SARS-CoV-2 antigen titer in the specimen falls below the minimum detection limit of this kit.
  11. If the extraction reagent is supplied individually (one piece per test device), the batch number, expiration date and other information cannot be marked separately due to limited space, but those details will be consistent with the corresponding test kit.
  12. Both symptomatic and asymptomatic infections can be tested.
Store at 4℃~30℃, and it is valid for 24 months. After the aluminum foil bag is unsealed, the test device should be used as soon as possible and within one hour.
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Saliva antigen rapid test kit REALY

A rapid test for the qualitative detection of novel coronavirus antigens in human saliva.
For professional use only. The saliva test is a convenient and safe method for assessing the risk of being infected with the novel coronavirus COVID-19. This helps you decide how to proceed regarding immediate treatment. The test results can be interpreted quickly in 10-20 minutes. Accuracy = 96.79% Sensitivity = 92.9% Specificity = 99.58% Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients. Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit. Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit. Important! Negative test results do not completely rule out being infected with SARS-CoV-2. If you continue to suspect any symptoms, further testing is strongly recommended. Call the family doctor hotline 1220.   Intended use: The Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Device (saliva) is an in vitro diagnostic test for the qualitative detection of the nucleoprotein and spike glycoprotein of the Coronavirus Disease 2019 in human Oropharyngeal saliva. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen. It will provide information for clinical doctors to prescribe correct medications.   Directions for use: The oral fluid specimen should be collected using the collection tools provided with the kit. Follow the detailed Directions for Use below. No other collection tools should be used with this assay. Oral fluid collected at any time of the day may be used.
  1. Allow the test device, specimen, and extraction buffer to equilibrate to room temperature (15-30°C) prior to testing. Do not place anything in the mouth including food, drink, gum, tobacco, water and mouthwash products, for at least 10 minutes prior to collecting the oral fluid specimen.
  2. Spit enough saliva into the saliva collection cup/bag.
  3. Take out an extraction tube and a bottle of extraction buffer, remove the extraction buffer bottle cap, and add all the extraction buffer into the extraction tube.
  4. Draw enough saliva from the cup with a dropper. Make sure the liquid level does not exceed the tunnel between the lower air bag and the plastic pipe. Transfer all saliva in the plastic pipe into the extraction tube.
  5. Take out a nozzle and use it to close the extraction tube. Gently shake the extraction tube vertically for about 5 seconds to allow the saliva to mix well with the extraction buffer. Fold the used cup/bag in half and discard it into the plastic bag as medical waste in accordance with local regulations.
  6. Remove the test device from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch. Put the test device on a clean and flat surface. Transfer 3 drops of sample into the sample well of the test device vertically. Start the timer.
  7. Read the result after 10~20 minutes. Do not interpret the result after 20 minutes.
  Interpretation of results:
  1. POSITIVE: Two red lines appear. One red line appears in the control region (C), and one red line in the test region (T). The shade of color may vary, but it should be considered positive whenever there is even a faint line.
  2. NEGATIVE: Only one red line appears in the control region (C), and no line in the test region (T). The negative result indicates that there are no Novel coronavirus particles in the sample or the number of viral particles is below the detectable range.
  3. INVALID: No red line appears in the control region (C). The test is invalid even if there is a line on test region (T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
  Precautions:
  • For professional use only.
  • Do not use after the expiration date.
  • Ensure the foil pouch containing the test device is not damaged before opening for use.
  • Perform test at room temperature 15 to 30°C.
  • Wear gloves when hanging the samples, avoid touching the reagent membrane and the sample window.
  • All samples and used accessories should be treated as infectious and discarded according to local regulations.
  • Avoid using bloody samples.
  Store the Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test device (saliva) at room temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and the buffer vial.
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Saliva antigen rapid test pen Rapid Response

WORLD’S FIRST ‘NO-SPIT’ SALIVA ANTIGEN RAPID TEST!
Taking the saliva sample straight from inside the mouth is the most convenient and fastest method for detecting the presence of coronavirus. The results will help you decide how to proceed further. ALL IN ONE – No need to waste time setting up a workstation and handle numerous assay components. All you need is one pen that can be used comfortably in any location. First and the only no-spit test dedicated to COVID-19 in the world! Its sponge-like pen tip will collect a sufficient volume of specimen in 2 mins without the need to spit and avoiding uncomfortable nasal/throat swabbing. The test results can be interpreted quickly in 15 minutes. Accuracy = 95.3% Sensitivity = 90% Specificity = 97% Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients. Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit. Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit. For professional use only. Important! Negative test results do not completely rule out being infected with SARS-CoV-2. If you continue to suspect any symptoms, further testing is strongly recommended. Call the family doctor hotline 1220. Test principle: The Rapid Response® COVID-19 Antigen Rapid Test Pen (Saliva) is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from saliva samples through visual interpretation of colour development. This test is intended for professional use only. The Rapid Response® COVID-19 Antigen Saliva Test Kit detects SARS-CoV-2 viral antigens through visual interpretation of colour development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to coloured particles are immobilized on the conjugated pad. A sample is added to the Extraction Buffer which is optimized to release the SARS-CoV-2 antigens from specimen. During testing, target antigens, if present in the saliva samples, will be released into the Extraction Buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to coloured particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess coloured particles are captured at the internal control zone. The presence of a coloured band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A coloured band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working. Test procedure: Bring devices to room temperature (18~30℃) before use.
  1. The Rapid Response® COVID-19 Antigen Saliva Test Kit is for professional use and should only be used for the qualitative detection of SARS-CoV-2 antigen. The intensity of colour in a positive band should not be evaluated as “quantitative or semi-quantitative”.
  2. Both viable and nonviable SARS-CoV-2 viruses are detectable with the Rapid Response® COVID-19 Antigen Saliva Test Kit.
  3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test but should only be made by the physician after all clinical and laboratory findings have been evaluated.
  4. Failure to follow the TEST PROCEDURE and RESULT INTERPRETATION may adversely affect test performance and/or invalidate the test result.
  5. Results obtained with this assay, particularly in the case of weak test lines that are difficult to interpret, should be used in conjunction with other clinical information available to the physician.
  6. Negative results do not preclude SARS-CoV-2 infection and should be confirmed via molecular assay.
Result interpretation:
  1. POSITIVE: Two coloured bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
  2. NEGATIVE: Only one coloured band appears, in the control region (C): No apparent coloured band appears in the test region (T).
  3. INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
  1. The colour intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of colour in the test region should be considered positive. Note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen.
  2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
Precautions:
  1. For professional use only.
  2. Read the Package Insert prior to use. Directions should be read and followed carefully.
  3. Do not use kit or components beyond the expiration date.
  4. Do not eat, drink, smoke, brush teeth or chew gum for 30 minutes before collecting saliva.
  5. The device contains material of animal origin and should be handled as a potential biohazard.
  6. Do not use if pouch is damaged or open.
  7. Test devices are packaged in foil pouches that exclude moisture during storage. Inspect each foil pouch before opening. Do not use devices that have holes in the foil or where the pouch has not been completely sealed. Erroneous result may occur if test reagents or components are improperly stored.
  8. Do not use the Extraction Buffer if it is discoloured or turbid. Discolouration or turbidity may be a sign of microbial contamination.
  9. All patient specimens should be handled and discarded as if they are biologically hazardous. All specimens must be mixed thoroughly before testing to ensure a representative sample prior to testing.
  10. Failure to bring specimens and reagents to room temperature before testing may decrease assay sensitivity. Inaccurate or inappropriate specimen collection, storage, and transport may yield false negative test results.
  11. Avoid skin contact with Extraction Buffer.
  12. If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions and sent to state or local health departments for testing.
  13. Viral isolation in cell culture and initial characterization of viral agents recovered in cultures of SARS-CoV-2 specimens are NOT recommended, except in a BSL3 laboratory using BSL3 work practices.
Store the Rapid Response® COVID-19 Antigen Saliva Test Kit at 2~30℃ when not in use. DO NOT FREEZE. Kit contents are stable until the expiration dates marked on their outer packaging and containers.
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