Control line:Goat anti- rabbit IgG antibody

COVID19 Neutralization Antibody Quantitative Test Kit Conjugate pad: fluorescently labeled 2019-nCoV RBD antigen and
(Fluorescence Immunochromatographic Assay) fluorescently labeled rabbit IgG antibody
whole blood 1 bottle 0.01mol/L PBS solution
buffer
IC card 1 copy It contains product name, batch number and other information.
【Product Name】Covid19 Neutralization Antibody Quantitative Test Kit (Fluorescence
Instruction for 1 pcs Paper
Immunochromatographic Assay)
Use
【Specification】1test/kit, 3tests/kit, 5tests/kit, 10tests/kit, 20tests/kit, 25tests/kit, 30tests/kit, 50tests/kit, Materials Required but not provided:
100tests/kit 1.10µL,100µL,1000µL pipettes
2.Timer
3.Vortex mixer
【Intended Use】 4.Tube rack for specimens
The kit is used for the qualitative detection of new coronavirus neutralizing antibodies in human serum, 5.Any necessary personal protective equipment
plasma and whole blood samples. The kit is clinically used in the evaluation of neutralizing antibodies in
recovered patients after infection with the new coronavirus or the auxiliary evaluation of the effect of the 【Storage Conditions and Validity】
new coronavirus vaccine.
1.This product should be stored in a dark and dry place at 2~30℃.The validity period of the kit is 18
For In-Vitro diagnostics only. For professional use only.
months.
2.After unpacking the aluminum foil bag of the test card, It should be used in the specified environment
【Summary】 (Temperature 2-35°C,Humidity 40%-90%) within 1 hour.
The kit is only for medical institutions and professionals.Laboratories carrying out new coronavirus testing 3.Please see label for the information about the date of manufacture and shelf life.
should meet the requirements of the "Laboratory Testing Guidelines for Pneumonia Infected by New
Coronavirus" and other requirements to do a good job in biosecurity. 【Applicable Instrument】
The New Coronavirus belong to the βgenus.The New Coronavirus is an acute respiratory infectious Used with fluorescence immunoassay analyzers of AEHEALTH LIMITED.
disease.People are generally susceptible.Currently, the patients infected by the new coronavirus are the
【Sample Collection Handind】
main source of infection; asymptomatic infected people can also be an infectious source.Based on the
1. This kit is used to detect human serum/plasma/whole blood samples. The plasma and whole blood
current epidemiological investigation, the incubation period is 1 to 14 days,mostly 3 to 7 days.The main
samples are recommended to use EDTA, heparin or sodium citrate for anticoagulation. Other body
manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia
fluids and samples may not get accurate results.
and diarrhea are found in a few cases.
2. The collection of sample: The collection and testing of patient blood samples must be performed in
In the early stage of the disease, the total number of white blood cells in the peripheral blood is normal or
accordance with the guidelines issued by the National Health Commission.
decreased and the lymphocyte count decreased.Some patients had increased liver enzymes, muscle
3. After the blood samples are collected, if they cannot be tested in time, the serum/plasma should be
enzymes and myoglobin.CRP and erythrocyte sedimentation rate are elevated in most patients and
stored at 2-8°C for 7 days. The sample can be stored for 30 days under -15°C.The whole blood
procalcitonin is normal at same time.In severe cases,D-dimer increases and peripheral blood lymphocytes
samples should not be frozen and can be stored for 3 days at 2-8°C.
progressively decrease.The New Coronavirus nucleic acid can be detected in throat swabs,sputum,lower
respiratory tract secretions, blood and other samples.The antibody which is tested in the serum helps 【Test Method】
confirm the infection status of the case. 1. Read the instructions for use completely before testing
At present, most of the new coronavirus neutralizing antibodies target the S1 subunit of the new 2. Before use, take out the reagents and specimens ,places the reagent on a flat table and balance
coronavirus spike protein and the receptor-binding domain (RBD) that binds the virus with high affinity,
them to room temperature (18-25℃).
blocking the binding of the viral receptor binding domain with Angiotensin-converting enzyme 2 and ACE2
3. The operators take the test card out of the packaging bag and place it on the platform table.
on the surface of human cells, to achieve the effect of neutralizing virus virulence, alleviating disease
symptoms, and reducing the mortality of infected persons. 4. Swipe the IC card information to the equipment，the operators confirm whether the batch number of
the IC card and the test card are match.
【Test Principle】 5. Add the specimens
The basic principle used in this kit is immunochromatographic competition. The detection line (T-line) on For Serum or Plasma Specimens
the test strip is coated with angiotensin converting enzyme 2 and the control line (C-line) is coated with The operator uses a pipette to absorb 50 µL of the sample, add it to the sample hole. After finish
goat anti-rabbit IgG antibody. The conjugate pad is coated with fluorescently labeled 2019-nCoV RBD sampling, the operators start timing and keep it react for 15 minutes.
antigen and fluorescently labeled rabbit IgG antibody during detection, when the sample contains the For Whole blood samples
antibody to be tested, the conjugate of the test substance in the sample and the fluorescent antigen forms The operator uses a pipette to absorb 50 µL of the sample, add it to the sample hole. Immediately add 1
an immune complex and the immune complex can no longer bind to the angiotensin-converting enzyme 2 drop of whole blood buffer to the sample hole After finish sampling, the operators start timing and keep it
immobilized on the nitrocellulose membrane. The fluorescent antigen conjugate that is not bound to the react for 15 minutes.
antibody to be tested will bind to the angiotensin converting enzyme 2 immobilized on the nitrocellulose 6. Test:
membrane to form a detection line (T). Real time detection
After 15 minutes of sample adding reaction, insert the detection card into the carrier of the fluorescence
【Main components】 immunoassay analyzer, press the "instant detection" button, and the instrument will automatically detect
and print the results;
Materials Provided: Timing detection
Name Quantity Main components
Test Card 25 pcs Detection line (T line):angiotensin-converting enzyme 2
 Insert the detection card into the carrier of the fluorescence immune analyzer immediately after adding 【Instruction Version】
the sample, press the "timing detection" button, the instrument will count down, automatically detect, Version:V1.0
give the test results and print.
7．Quality Control: When the control line (C-line) of the test card is abnormal, the immunofluorescence 【Index of CE Symbols】
analyzer displays " Reagent detection error " indicates that the test result of the test card is invalid. The product is used in vitro,
Please don’t reuse it
please don’t swallow it.
【Interpretation of test results】
The test result is drawn by ROC curve. When the positive judgment value: inhibition rate is 30%, the Please read the instruction book
Youden index is the highest and the product has the best sensitivity and specificity. Therefore, the positive Validity
judgment value: inhibition rate is 30%.. carefully before using

【Reporting Of Results】 Warning, please refer to the

Manufacturer
If the sample inhibition rate is less than or equal to 30% indicates that the sample is negative. instruction in the annex
If the sample inhibition rate is more than 30% indicates that the sample is positive.
Invalid: If the fluorescence value of the control line (C-line) is lower than the threshold indicates that there Temperature scope within
is an incorrect operation process or the deterioration of the reagents. Please take a new test card and Batch number
which the product is reserved
perform the test again. If the same problem still occurs, stop using the batch of products immediately and
contact the manufacturer. European union authorization
【Limitation of the test】 Keep dry
1. The kit can be used for the detection of human serum, plasma or whole blood samples. The representative
reliability of the determination of this substance in other types of samples has not been fully
confirmed. Don’t use the product when the
2. The result of this kit is only one of the indicators for the clinician to diagnose the patient and it needs Avoid overexposure to the sun
to be judged based on the clinical symptoms. package is damaged
3. If the results are inconsistent with the clinical symptoms, please retest and confirm the test results
with the clinical symptoms.
4. In the early stage of infection, the new coronavirus neutralizing antibody is not produced or the titer Date of manufacture Biological risks
is lower than the detection limit which will lead to a negative result. For suspected negative results,
other methods with higher sensitivity are recommended for review. Samples with positive test results
should be retested or confirmed using different methodologies. The confirmation of viral infection The product meets the basic requirements of European in vitro diagnostic medical
should be combined with the patient's clinical history, symptoms and other diagnostic results. devices directive 98/79/EC
5. The test results of this product and other different methodological reagents are not equivalent.

【Peformance Characteristics】 【Basic Information】

1. The coincidence rate (+/+) of the positive reference product should be 5/5.
2. The coincidence rate (-/-) of the negative reference product should be 10/10.
AEHEALTH LIMITED
3. LoD:The results of L1~L2 should be positive and the results of L3~L4 should be negative.
Address: Unit G25 Waterfront Studios, 1 Dock Road, London, United Kingdom, E16 1Ah
4. Repeatability:The test results of the J1 samples should all be positive and there are no colour
Web：www.aehealth.uk Email: sales@aehealth.uk
appears and the test results of the J2 samples should all be negative and the color should be
uniform.
5. Specificity:H1N1 (new type A H1N1 influenza virus (2009), seasonal H1N1 influenza
virus);H3N2;H5N1;H7N9;Influenza B Yamagata;Influenza B Victoria;Respiratory syncytial MedNet GmbH
virus;Rhinovirus A, B,C groups;Adenovirus type 1,2,3,4,5,7,55;Enterovirus A,B,C,D groups;Epstein- ADD: Borkstrasse 10, 48163 Muenster, Germany
Barr virus;Measles virus;Human cytomegalovirus;Rotavirus;Norovirus;Mumps virus;Varicella-zoster
virus;Mycoplasma pneumoniae;Chlamydia pneumoniae antibodies do not cross-react.
6. Interfering substances:The Concentrations of triglycerides 40mmol/L,hemoglobin 2g/L,rheumatoid
factor 1000IU/mL,bilirubin 350μmol/L and HAMA 600ng/mL have no effect on the test results.

【Precautions】
1. After opening the package, the kit should be ready for use as soon as possible and avoid placing it
in a high temperature (over 30°C) and high humidity environment for a long time.
2. All samples (whole blood, serum and plasma) and test cards after use should be considered
potentially dangerous and should be treated as infectious materials, and the waste should be
disposed of in accordance with the regulations of the hospital or environmental protection
department.
3. The test strips with any color lines before the test should not be used and the reagents with
damaged packaging bags or invalid seals should not be used.
4. The kit is for in vitro diagnostic use only. The kit is for single-use, please do not use the product after
it expires.