GenSure COVID-19 Neutralizing Antibody Test Instruction Manual

GenSure COVID-19 Neutralizing Antibody Test

Instructions Manual

For professional use only

Product Name

• Common name: GenSureTM COVID-19 Neutralizing Antibody Test (Latex) REF: P2006

Packing Specification

• Cassette : 1/ bag Kit: 20 / box

Intended Use

The COVID-19 Neutralizing Antibody Rapid Test (Latex) is a lateral flow assay intended for the qualitative detection of RBD antibody to SARS-CoV-2 in human serum, plasma or whole blood in vitro. The critical neutralizing domain that is contained in the receptor-binding domain (RBD) of the spike protein (S protein) could lead to a highly potent neutralizing antibody response. This kit is used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. 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 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.

Test Principle

The COVID-19 Neutralizing Antibody Rapid Test (Latex) is a lateral flow assay based on the principle of latex microsphere immunochromat- ography. During the test, a blood specimen is added to the specimen well of the cassette.If the specimen contains RBD antibody to SARS-CoV-2, these antibodies first combind with the colored latex microsphere-labeled SARS-CoV- 2 RBD antigen protein to form an immuno-complex, which flow onto the nitrocellulose membrane. When this immuno-complex reaches the test line(T line), it reacts with the secondary antibody anti-human IgG antibody pre-coated there.Therefore, a visible red line appeared on the T line, which indicates a positive result. If no RBD antibody to SARS-CoV-2 is present in the specimens, the red line will not be formed on the test line (T line), which indicates a negative result. Regardless of whether the specimen contains RBD antibody to SARS-CoV-2, a red line should appear on the quality control line (C line) during the test to prove that the test cassette is working properly.

Main Ingredients

• 1. Material Provided:
• 1. 20 test cassettes; 2) 20 bottles of specimen buffer; 3) 20 disposable blood collecting needles;
• 4. 20 pipettes; 5) 20 alcohol pad or alcohol swabs (optional); 6) 1 instructions manual.
• 2. Material required but not provided: Timer.

Storage Conditions and Stability

• Store at 4-30℃, protected from light, stable for 18 months. See product label for production date and expiration date.

Specimen Requirements

1. The applicable specimen type for this test kit is serum / plasma / whole blood (including peripheral blood).
2. The whole blood is drawn according to the standard clinical laboratory method, and serum or plasma is separated, and hemolysis should be avoided as much as possible during processing.
3. Plasma specimens can be collected using EDTA or heparin anticoagulant blood vessels. The specimens should be tested as soon as possible after collection to avoid leaving them for a long time at room temperature. Serum or plasma specimens should be tested after collection as soon as possible, or it must be stored at 2-8℃for 3 days. If longer storage is required, it should be stored at -20℃( -70℃if possible). It is not recommended to use severe hemolytic specimens. Whole blood specimens should be tested after collection as soon as possible, or must be stored at 2-8℃ for 3 days. It is not recommended to use specimens for more than 3 days.
4. The specimen must be returned to room temperature before testing. The frozen specimens need to be completely melted, rewarmed and mixed before use. They should be slowly returned to room temperature and stirred. When the particles in the specimen are clearly visible, the precipitate should be removed by centrifugation before testing. Avoid repeated freezing and thawing.

Testing Method

1. Please read the instruction manual carefully before testing.
2. Take out the test cassette, specimen buffer, etc., and use it after returning to room temperature. When everything is ready, tear off the aluminum foil bag, take out the test cassette and place it on the platform. After opening the aluminum foil bag, the test cassette should be used as soon as possible within 1 hour.
3. Add sample: Aspirate the plasma / serum / whole blood sample with the sample pipette, add 1 drop (approximately 10ul) of sample to the sample well of the test cassette, and then tear off the specimen buffer bottle, add 4 drops of specimen buffer to the sample well.
4. Observe the results within 10-15 minutes after the sample is added, do not observe the result after 15 minutes.

Interpretation of test results

Positive

Two lines appear. One colored line appears at the control region (C), and another colored line appears at the test region (T), irregardless of the intensity of the test line.

Negative

One colored line appears at the control region (C), and no line appears at the test region (T).

Invalid

Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test cassette. If the problem persists, discontinue using the lot immediately and contact your local distributor.

Limitations Of Detection Methods

1. This test kit is only used for the qualitative detection of RBD antibody to SARS-CoV-2 present in human blood specimen.
2. The positive result only indicates that the RBD antibody to SARS-CoV-2 may be present, and it cannot be used other pathogens.
3. Negative results cannot completely rule out the possibility of presence of RBD antibody to SARS-CoV-2. It may be that the level of the RBD antibody to SARS-CoV-2 is too low to be detected by this kit.
4. Inconsistent or erroneous results may occur due to improper technical or procedures, contaminated specimens, hemolysis, or the presence of drugs that interfere with the test.
5. Testing with a molecular diagnostic should be performed to evaluate for active infection in patients and the test results must be evaluated in conjunction with other clinical data available to the physician.
6. To obtain accurate results, the instructions manual must be followed.

Precautions

1. This product is for in vitro testing only.
2. If the specimen is suspected to be contaminated, re-sampling should be performed.
3. Do not use expired kits.
4. Do not open the sealed pouch until you are ready to conduct the assay. Once opened, the test cassette should be used within 1 hour.
5. All specimens shall be treated as infectious materials during the test.
6. Specimen collection and handling procedures require specific training and guidance.
7. When testing specimens, wear suitable protective clothing, gloves, and eye/face protection.
8. Wash hands thoroughly after handling.
9. The used test cassette should be discarded according to federal, state and local regulations.
10. Note: If the speicmen is contaminated or abnormal, or the specimen handling method and testing method are not carried out in accordance with the instructions manual, the result will be incorrect, which has nothing to do with product quality.

Clinical Performance

1. The clinical performance of COVID-19 Neutralizing Antibody Rapid Test (Latex) used for auxiliary diagnosis of SARS-CoV-2 infection was established with a study using 629 previously collected specimens.The sensitivity of COVID-19 Neutralizing Antibody Rapid Test is 96.65% (95% CI = 93.25%~98.37%), the specificity is 99.52% (95% CI = 98.28%~99.87%), and the total coincidence rate is 98.57% (95% CI = 97.30%~99.25%).
2. The clinical performance of COVID-19 Neutralizing Antibody Rapid Test (Latex) used for detecting whether the RBD antibody to SARS-CoV-2 is generated in the blood after injected with the vaccine was established with a study using 646 previously collected specimens.

The sensitivity of COVID-19 Neutralizing Antibody Rapid Test is 96.46% (95% CI = 93.17%~98.20%), the specificity is 99.29% (95% CI = 97.92%~99.76%), and the total coincidence rate is 98.30% (95% CI = 96.98%~99.05%).

Analytical Performance

1. Cross-Reactivity Cross reactivity of COVID-19 Neutralizing Antibody Rapid Test (Latex) was evaluated by testing various material that could cross-react with COVID-19 Neutralizing Antibody Rapid Test (Latex). The result showed no cross reactivity.
2. Interference There is no interference with the potential interfering substances listed below.

Basic Information

Registrant / Manufacturer: GenSure Biotech Inc., Registered address: B1-78, Rizhongtian Science and Technology Park, No.585 Tianshan Street, Shijiazhuang High-tech Zone, 050000, Hebei, P.R.China Tel: +0086-(0)311-8993 7995 +0086-(0)311-89937996 Production address: 3/F, Block 1, Boyun Bldg, No. 9 Fengchan Rd, Economic-Tech Zone, Shijiazhuang, 050000, Hebei, P.R China. E-mail: [email protected] Web: www.gensbio.com

European Authorized Representative

OSMUNDA Medical Technology Service GmbH Address: Treskowallee 108, 10318 Berlin, Germany E-mail: [email protected] Tel: +49-30-8186 5123 Fax: +49 30 4699 5929

Instructions Manual Revision Date and Version

Revision Date: 2021.08.19 Version No.: 21.08

References

• 河北精硕生物科技有限公司

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