COVID-19 (SARS-CoV-2) neutralizing antibody Rapid
Test if an affective vaccine has been administrated or if the subject has had a sufficient antbody reaction to be protected.
For the qualitative assessment of COVID-19 (SARS-CoV-2) neutralizing antibody in human serum/plasma/whole blood
For professional In Vitro Diagnostic Use Only
Lieven Gevaert, Bio-ir. RUG1996
COVID-19 (SARS-CoV-2) neutralizing antibody Rapid Test Device is an InvBio lateral flow
immunoassay intendes for the qualitative detection of neutralizing antibody of SARS-CoV-2 in
human whole blood,serum,or plasma as an aid in the Evaluation levels of human anti-novel coronavirus neutralizing antibody titer.
- 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 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, angiotens in 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 or SARS-COV-2 Vaccine immunization initiates an immune response to produce antibodies which provide protection against future infections from viruses.
- Human neutralizing antibodies that target the host ACE2 receptor-binding domain (RBS) of the SAR-COV-2 spike protein show promise therapeutically and efficiency protectively.
- 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.
STORAGE AND STABILITY
1. The original packaging should be stored at 2~ 30℃,to avoid light, keep dry.
2. The test device is stable through the expiration date printed on the sealed pouch.The test device must remain in the sealed pouch until use.
DO NOT FREEZE.
3. Do not use beyond the expiration date, especially at temperatures above 30℃ or under high
humidity conditions, should be used immediately once it is opened.
SPECIMEN COLLECTION AND PREPARATION
- 1. COVID-19 (SARS-CoV-2) neutralizing antibody Rapid Test Device is intended for use with
human whole blood, serum or plasma specimens only.
- 2. Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
- 3. Perform testing immediately after specimen collection. Do not leave specimens at room
temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C
for up to 3 days. For long term storage, serum or plasma specimens should be kept below
-20°C.Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be
run within 2 days after collection.
- Do not freeze whole blood specimens.
- Whole bloo collected by fingerstick should be tested immediately.
4. Containers containing anticoagulants such as EDTA,citrate,or heparin should be used for whole blood storage.
5. Bring specimens to room temperature prior to testing.Frozen specimens must be completely
thawed and mixed well prior to testing.Avoid repeated freezing and thawing of specimens.
6. If specimens are to be shipped, pack them in compliance with all applicable regulations for
transportation of etiological agents.
7. Icteric,lipemic,hemolyzed,heat treated and contaminated sera may cause erroneous results.
8. When collecting finger stick blood with a lancet and alcohol pad, Please discard the first drop of whole blood
Test Devices Buffer 25µL Disposable plastic pipette Package insert
Materials required but not provided
Specimen collection containers Centrifuge (for plasma only) Micropipette Timer Lancets (for finger stick whole blood only) Alcohol pad
DIRECTIONS FOR USE
Allow the test device,specimen,buffer,and/or controls to reach room temperature (15-30°C) prior
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 drop 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 5µL 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 region（R）
appears and a colored line appears in test line region（T）. 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 region（R）appears and a colored line appears in test line region（T）. 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 region（R）appears and no colored line appears in test line region（T）.The result is high positive and Neutralizing antibodies provide high protection. [NEGATIVE]: The colored line in the control line region (C) and reference line region（R）
appears and a colored line appears in test line region（T）. 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. QUALITY CONTROL
Internal procedural controls are included in the test. A color line appearing in the control region
(C) is an internal positive procedural control.It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit;however,it is recommended that positive and
negative controls be tested as a good laboratory practice to confirm the test procedure and to
verify proper test performance.
Sensitivity and Specificity The Covid-19 (SAR-CoV-2) neutralizing antibody is produced by the human body after natural
immunity and vaccine injection, and protects the human body from SAR-CoV-2 infection. Based
on the SAR-CoV-2 vaccine procedure, the recommendations for using this reagent to monitor
the content of SAR-Cov-2 neutralizing antibodies in the human body are as follows: Expected Result during
vaccination COVID-19 (SARS-CoV-2) 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 √ √
Sensitivity and Specificity The COVID-19 (SARS-CoV-2) neutralizing antibody Rapid Test Device has been compared to a
leading commercial COVID-19 IgG testing using clinical specimens from Naturally infected
patients Method COVID-19 (SARS-CoV-2) neutralizing antibody Rapid Test Device Total Results COVID-19
antibody Rapid Test Device Results Low
Positive Mid Positive High Positive Negative Positive 32 72 41 7 152 Negative 0 0 0 371 371 Total Results 32 72 41 379 523 Relative Sensitivity: 145/152=95.39%
Relative Specificity: 371/371=>99.9%
Cross-reactivity COVID-19 (SARS-CoV-2) neutralizing antibody Rapid Test Device has been tested for anti-influenza A virus,anti-influenza B
factor,anti-M.Pneumonia,anti-Chlamydiapneumoniae and anti-HCV positive specimens. The
results showed no cross-reactivity.
Interfering Substances The following compounds have been tested using the COVID-19 (SARS-CoV-2) neutralizing
antibody Rapid Test Device and no interference was observed. Triglyceride:5000mg/dL Ascorbic Acid: 20mg/dL Hemoglobin 1000mg/dL Bilirubin: 60mg/dL Oxalic acid: 100mg/dL Human serum albumin 2000mg/dL
LIMITATION OF USE
1. The accuracy of the test depends on the sample collection process. Improper sample
collection, improper storage of samples, stale samples, or repeated freeze-thaw cycles of samples will affect the test results. 2. The test Device only provides qualitative detection of the neutralizing antibody of SARS-CoV-2 in the sample.If you need to detect the specific content of an indicator, please use
the relevant professional instruments. 3. The test result of this kit is for clinical reference only and should not be used as the sole basis
for clinical diagnosis and treatment. The clinical management of patients should be considered
in combination with their symptoms/signs, medical history, other laboratory tests, and treatment responses.
4. It is recommended to review the suspicious negative results by using nucleic acid detection
or virus culture identification methods. 5. Analysis of the possibility of false negative results：
① Unreasonable sample collection, transportation and processing may lead to false negative
results. ② Genetic variations of virus can cause changes in antibody determinants, which can lead to
false negative results. ③ The optimal sample type and sampling time after infection have not been verified, so
collecting samples at different times on the same patient may avoid false negative results.
Biological risks The product meets the basic
requirements of European in
vitro. diagnostic medical ISO 13485 notified body.
[Instruction Approval and Revision Date]
Revision Date: 2021-01-10
Date of Issue: 2021-01-10
Innovation Bio European Authorized Representative:
Gentaur B.V., Eersel, Netherlands E-mail: firstname.lastname@example.org
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