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      Novel Coronavirus Neutralizing Antibody Rapid Test Device

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      ——For the qualitative assessment of Coronavirus Disease 2019 (2019-nCOV or COVID-19)

      neutralizing antibody in human serum/plasma/whole blood.?For professional In Vitro Diagnostic Use Only.

      SUMMARY

      The novel coronaviruses belong to the βgenus.COVID-19 is an acute respiratory infectious?disease. People are generally susceptible. Currently, the patients infected by the novel?coronavirus are the main 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 diarrhea are found in a few cases.

      Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an?enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease?2019 (COVID-19), which is contagious in humans.

      SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M)?and nucleocapsid (N). The spike protein (S) contains a receptor binding domain (RBD), which is?responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ACE2).

      It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2?receptor leading to endocytosis into the host cells of the deep lung and viral replication.Infection with the SARS-CoV-2 initiates an immune response, which includes the production of?antibodies in the blood. The secreted antibodies provide protection against future infections?from viruses, because they remain in the circulatory system for months to years after infection?and will bind quickly and strongly to the pathogen to block cellular infiltration and replication.These antibodies are named neutralizing antibodies.

      PRINCIPLE

      This kit uses immunochromatography. The test card contains:1)colloidal gold-labeled?recombinant novel coronavirus S-RBD antigen, refer control and quality control antibody gold?markers; 2) one detection line(T line), one reference line(R line) and one quality Control line (Cline) of nitrocellulose membrane.The T line is immobilized with Human ACE2 protein for?detecting novel coronavirus neutralizing antibody;the R line is immobilized with reference?control antibody; and the C line is immobilized with a quality control antibody.When an appropriate amount of the test sample is added to the sample hole of the test card, the?sample will move forward along the test card under the action of the capillary. If the sample?contains Novel coronavirus neutralizing antibody, the antibody will bind to the colloidal?gold-labeled novel coronavirus antigen. The rest gold-labeled novel coronavirus antigen in?immune complex will be captured by the human ACE2 protein immobilized on the membrane to?form a purple-red T line,the intensity of t line Inversely proportional to the concentration of?antibody.

      The test card also contains a quality control line C and a reference line R.The fuchsia quality?control line C and reference control line R should appear regardless of whether a test line?appears.If the quality control line C does not appear, the test result is invalid, and the sample?needs to be tested again with another test card.

      DIRECTIONS FOR USE

      Allow the test device,specimen,buffer,and/or controls to reach room temperature (15-30°C) prior?to testing.

      1. Bring the pouch to room temperature before opening.Remove the test device from the?sealed pouch and use it as soon as possible.

      2. Place the test device on a clean and level surface.For Serum or Plasma Specimens:Using the provided 25μL disposable pipette,and transfer 2 drops of serum/plasma to?the specimen well of the test device,then add 1 drop of buffer,and start the timer. ? For Whole Blood (Venipuncture/Fingerstick) Specimens:Using the provided 25μL disposable pipette,and transfer 3 drops of whole blood(approximately 75μL) to the specimen well of the test device,then add 1 drop of buffer,and start the timer.

      Note: Specimens can also be applied using a micropipette.

      3. Wait for the colored line(s) to appear.Read results at 10 minutes.Do not interpret the?result after 15 minutes.

      nn

      INTERPRETATION OF RESULTS

      Low POSITIVE:*The colored line in the control line region (C) and reference line regionRappears and a colored line appears in test line regionT. and the intensity of T line is weaker?than C line but stronger than R line,The result is low positive and Neutralizing antibodies provide?weak protection.

      Middle POSITIVE:*The colored line in the control line region (C) and reference line regionRappears and a colored line appears in test line regionT. and the intensity of T line is weaker?than R line,The result is middle positive and Neutralizing antibodies provide middle protection.

      High POSITIVE:*The colored line in the control line region (C) and reference line regionRappears and no colored line appears in test line regionT.The result is high positive and?Neutralizing antibodies provide high protection.

      NEGATIVE: The colored line in the control line region (C) and reference line regionRappears?and a colored line appears in test line regionT. and the intensity of T line is stronger than Cline,The result is negative and no Neutralizing antibodies in your body,you are easily infected?with the novel coronavirus If you are exposed to the virus, .

      INVALID: There is no line appeared in the C region.

      Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for?control line failure.Review the procedure and repeat the procedure with a new test device. If the?problem persists,discontinue using the test kit immediately and contact your local distributor.

      EXPECTED RESULTS AFTER VACCINATION

      Expected Result during

      vaccination

      Novel coronavirus neutralizing antibody?Rapid Test Device

      Low Positive

      Mid Positive

      High Positive

      Negative

      Days before Dose 1

      ?

      ?

      ?

      21 Days after Dose 1

      ?

      ?

      7 Days after Dose 2

      ?

      ?

      14 Days after Dose 2

      ?

      ?

      ?

      Novel Coronavirus Neutralizing Antibody Rapid Test Device

      ——For the qualitative assessment of Coronavirus Disease 2019 (2019-nCOV or COVID-19)

      neutralizing antibody in human serum/plasma/whole blood.?For professional In Vitro Diagnostic Use Only.

      SUMMARY

      The novel coronaviruses belong to the βgenus.COVID-19 is an acute respiratory infectious

      disease. People are generally susceptible. Currently, the patients infected by the novel

      coronavirus are the main 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 diarrhea are found in a few cases.

      Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an

      enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease

      2019 (COVID-19), which is contagious in humans.

      SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M)

      and nucleocapsid (N). The spike protein (S) contains a receptor binding domain (RBD), which is

      responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ACE2).

      It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2

      receptor leading to endocytosis into the host cells of the deep lung and viral replication.

      Infection with the SARS-CoV-2 initiates an immune response, which includes the production of

      antibodies in the blood. The secreted antibodies provide protection against future infections

      from viruses, because they remain in the circulatory system for months to years after infection

      and will bind quickly and strongly to the pathogen to block cellular infiltration and replication.

      These antibodies are named neutralizing antibodies.

      PRINCIPLE

      This kit uses immunochromatography. The test card contains:1)colloidal gold-labeled

      recombinant novel coronavirus S-RBD antigen, refer control and quality control antibody gold

      markers; 2) one detection line(T line), one reference line(R line) and one quality Control line (C

      line) of nitrocellulose membrane.The T line is immobilized with Human ACE2 protein for

      detecting novel coronavirus neutralizing antibody;the R line is immobilized with reference

      control antibody; and the C line is immobilized with a quality control antibody.

      When an appropriate amount of the test sample is added to the sample hole of the test card, the

      sample will move forward along the test card under the action of the capillary. If the sample

      contains Novel coronavirus neutralizing antibody, the antibody will bind to the colloidal

      gold-labeled novel coronavirus antigen. The rest gold-labeled novel coronavirus antigen in

      immune complex will be captured by the human ACE2 protein immobilized on the membrane to

      form a purple-red T line,the intensity of t line Inversely proportional to the concentration of

      antibody.

      The test card also contains a quality control line C and a reference line R.The fuchsia quality

      control line C and reference control line R should appear regardless of whether a test line

      appears.If the quality control line C does not appear, the test result is invalid, and the sample

      needs to be tested again with another test card.

      DIRECTIONS FOR USE

      Allow the test device,specimen,buffer,and/or controls to reach room temperature (15-30°C) prior

      to testing.

      1. Bring the pouch to room temperature before opening.Remove the test device from the

      sealed pouch and use it as soon as possible.

      2. Place the test device on a clean and level surface.

      For Serum or Plasma Specimens:

      Using the provided 25μL disposable pipette,and transfer 2 drops of serum/plasma to

      the specimen well of the test device,then add 1 drop of buffer,and start the timer. ? For Whole Blood (Venipuncture/Fingerstick) Specimens:

      Using the provided 25μL disposable pipette,and transfer 3 drops of whole blood

      (approximately 75μL) to the specimen well of the test device,then add 1 drop of buffer,

      and start the timer.

      Note: Specimens can also be applied using a micropipette.

      3. Wait for the colored line(s) to appear.Read results at 10 minutes.Do not interpret the

      result after 15 minutes.

      ?

      INTERPRETATION OF RESULTS

      Low POSITIVE:*The colored line in the control line region (C) and reference line regionR

      appears and a colored line appears in test line regionT. and the intensity of T line is weaker

      than C line but stronger than R line,The result is low positive and Neutralizing antibodies provide

      weak protection.

      Middle POSITIVE:*The colored line in the control line region (C) and reference line regionR

      appears and a colored line appears in test line regionT. and the intensity of T line is weaker

      than R line,The result is middle positive and Neutralizing antibodies provide middle protection.

      High POSITIVE:*The colored line in the control line region (C) and reference line regionR

      appears and no colored line appears in test line regionT.The result is high positive and

      Neutralizing antibodies provide high protection.

      NEGATIVE: The colored line in the control line region (C) and reference line regionRappears

      and a colored line appears in test line regionT. and the intensity of T line is stronger than C

      line,The result is negative and no Neutralizing antibodies in your body,you are easily infected

      with the novel coronavirus If you are exposed to the virus, .

      INVALID: There is no line appeared in the C region.

      Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for

      control line failure.Review the procedure and repeat the procedure with a new test device. If the

      problem persists,discontinue using the test kit immediately and contact your local distributor.

      EXPECTED RESULTS AFTER VACCINATION

      Expected Result during

      vaccination

      Novel coronavirus neutralizing antibody?Rapid Test Device

      Low Positive

      Mid Positive

      High Positive

      Negative

      Days before Dose 1

      ?

      ?

      ?

      21 Days after Dose 1

      ?

      ?

      7 Days after Dose 2

      ?

      ?

      14 Days after Dose 2

      ?

      ?

      ?


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