COVID-19 IgG/IgM Rapid Test Cassette
CONTACT : anna.int@newscen.com
WHATSUP: :+8617386579392(WhatsApp)
TEL:008689589611
For the qualitative detection of IgG/IgM antibodies in serum/plasma and whole blood
(Single use test cassette)
The instruction must be read carefully and completely prior to the use of COVID-19 IgG/IgM Rapid Test Cassette. Instruction must be followed carefully. If directions are not followed exactly, inaccurate test result may occur.Before performing testing, all operators must read and become familiar with Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virusand Other Blood-Borne Pathogens in Health-Care Settings.
INTENDED USE
COVID-19 IgG/IgM Rapid Test Cassetteis for the detection of IgG/IgM in human serum, plasma or whole blood. It cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by COVID-19.
PRINCIPLE
This kitusescolloidal gold immunochromatographyand indirect immune capture principle of comprehensive detection technology todetect IgG/IgM ofSevereAcuteRespiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum, plasma and whole blood.During detection, the colloidal goldlabeled recombinant antigens bind to the SARS-CoV-2antibodies in the sample to form immune complexes. The immune complexes move forward along the cassette by chromatography. The IgM in the immune complexes will be captured by the pre-coated anti-human IgM on the nitric acid fiber membrane, condense the color to form the reaction line M. The IgG in the immune complexes will be captured by the pre-coated anti-human IgG on the nitric acid fiber membrane, condense the color to form the reaction line G. The colloidal gold-labeled chicken IgY antibodiesare combined with the pre-coated goat anti-chicken IgY antibodies on the quality control line to form the quality control line C.
REAGENTS AND MATERIALS PROVIDED
1. Test cassette (individually pouched)
2. Each pouch contains one cassette with one desiccant bag
3. Diluent buffer
4. Instruction for use
MATERIALS REQUIRED BUT NOT PROVIDED
1. Timer or stopwatch
2. Blood collection devices, for the testing of venipuncture whole blood, serum or plasma
3. Biohazard disposal container
4. Disposable gloves
5. Pipette and pipette tip
Forfingerstick samples, the following materials are required:
Alcohol pad
Sterile lancet
Sterile gauze or cotton
WARNING
For in vitro diagnostic use ONLY
Read the package insert completely before use. It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false negative result (i.e. a missed positive).
PRECAUTIONS
1. This product is an in vitro diagnostic reagent to qualitatively detect the IgG/IgM of SARS-CoV-2 in human serum, plasma and whole blood.
2. Unqualified samples will lead to wrong results, such as the hemoglobin in the hemolysis sample>6g/L, triglycerides in hyperlipidemia samples>15g/L, bilirubin in jaundice samples> 0.2g/L,RF > 1200IU/mL in rheumatoid samples.
3. All the waste and specimen should be treated in case of transmitting disease and must be properly disinfected (autoclaving is preferred) before disposal.
4. Make sure the test is not expired (EXP Date is indicated on the kit box).
5. Do not use the test if the pouch has been perforated.
6. If pipette is used, calibrate pipette frequently to assure the accuracy of dispensing. Use a different disposal pipette tip for each specimen in order to avoid cross-contaminations.
7. Do not modify the test procedure.
8. Each test is for single use only.
9. Blood that has been chemically treated, heated, diluted, or otherwise modified may result in inaccurate results.
10. Always interpret the results under good light conditions to avoid misreading of the results. 11. Different batch of product components cannot be mixed.
12. If desiccant bag is not present in the pouch, DO NOT USE the test.
13. Always add accurate volume of specimen by following the instruction.
14.The test cassette must be used directly after unsealing. It is not allowed to divide it for use.
15. Do not touch the reaction zone of the reagent.
16.If the samples are stored in refrigerator, they should be placed in room temperature before testing.
17. If the detection reagent is stored in refrigerator, it should be restored to room temperature before testing.
18.Read the result in15~20 minutes. Interpret the test result after 20 minutes may cause false result.
STORAGE
COVID-19 IgG/IgM Rapid Test Cassetteshould be stored in dark place at 4-30°C for 12months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, perform the test as early as possible (within 1 hour) to avoid test cassette from becoming moist. Do not use the test beyond the indicated expiration date.
SAMPLE COLLECTION AND TEST PREPARATION
Fingerstick Specimens (Whole Blood)
1. Clean the area to be lanced with an alcohol pad.
2. Squeeze the end of the fingertip and pierce it with a sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton; collect the sample from the second drop.
4. Use dropper to draw the fresh blood to 1/2 of the tube wall and dispense into the sample well.
Fingerstick whole blood should be used immediately after collection.
Serum/Plasma specimens: fresh serum or plasma specimen can be used.
Plasma
1. Collect whole blood into a collection tube (containing EDTA, Na-citrate or heparin) by venipuncture.
2. Separate the plasma by centrifugation.
Serum
1. Collect whole blood into a collection tube (containing no anticoagulants) by venipuncture. 2. Allow the blood to clot.
3. Separate the serum by centrifugation.
Avoid the use of hemolytic, turbid, microorganism contaminated specimens. Specimen should be stored at 2-8°Cforup to 3days,refrigerate at -20°C for up to 9 days. Avoid specimen deterioration by multiple freeze-thaw cycles.
Venipuncture Whole Blood
Venipuncture whole blood can be used immediately after collection or stored up to 3 days at 2-8°C.
ASSAY PROCEDURE
1. Sample preparation: Fresh serum, plasma or whole blood samples, no pretreatment is required. If the samples are stored in 2~8°C, the samples should be restored at room temperature for 15~30 minutes before use, returned to room temperature, and thoroughly mixed before testing.
2. Reagent preparation: Open the package, pouch should be sealed well.If the test reagent stores in the refrigerator, it should be restoredto room temperature. Then open the package pouch and take out the test reagent, place it on the platform.
3. Detection and interpretation:Add 10μL serum/plasma or 20μL whole blood sample into S well,after the sample has permeated completely, add 2 drops diluent buffer. Read the result in 15～20 minutes, interpret the test result after 20 minutes may cause false result.
INTERPRETATION OF RESULTS
1.Positive of IgG and IgM:One color line in the control zone (C), one color line in the control zone (G) and one color line in the control zone (M). Indicates IgG and IgMtest result is positive.
2. Positive of IgG:One color line in the control zone (C) and one color line in the control zone (G), Indicates IgG test result is positive.
3.Positive of IgM:One color line in the control zone (C) and one color line in the control zone (M), Indicates IgM test result is positive.
4. Negative of IgG and IgM:Only one color line in the control zone (C), Indicates IgG and IgM test result is negative.
5. Invalid: If no color line appears in the control zone (C), the test is invalid. Discard the test cassette and perform with new cassette.
Built-In Control
COVID-19 IgG/IgM Rapid Test Cassette has a built-in procedural control that demonstrates assay validity. A color line appearedon the control zone (C) indicates that the test runs correctly.
LIMITATION
1. Thekit is only used to detect human serum, plasma and whole blood sample.
2. The accuracy of the test depends on the process of sample collection. Improper sample collection, improper sample storage or repeated freezing and thawing of samples will affect the test results.
3. The test results of this reagent are for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of the patient should be considered in combination with other laboratory tests of the patient's symptoms/signs history and treatment response.
4. Due to the limitation of antibody detection reagent methodology, nucleic acid detection or virus culture identification method is recommended to confirm the negative test results.
5. Too low levels of the virus in the sample can lead to false negative results.
6. The mutation of the virus gene may cause the change of the antibody determination cluster, resulting in false negative results.
PERFORMANCE CHARACTERISTICS
1. Negative reference sample coincidence rate: 10 negative enterprise reference samples were tested and the results were all negative.
2.Positive reference sample coincidence rate:5IgG positive enterprise reference samples were tested and the results were all positive. 5IgM positive enterprise references samples were tested and the results were all positive.
3. Minimum detectability:3 IgG enterprisereference samples of limited detection were used for testing,L1 should be negative,L2 was an uncertain result, and L3 should be positive.
3 IgG enterprisereference samples of limited detection were used for testing,L4 should be negative,L5was an uncertain result, and L6 should be positive.
4. Intra-lotrepeatability:Parallel test IgG enterprise repeatability reference sample 10 times, the color development results of parallel determination should be consistent and uniform.
Parallel test IgM enterprise repeatability reference sample 10 times, the color development results of parallel determination should be consistent and uniform.
5. Inter-lot repeatability:Parallel determination of IgG enterprise repeatability reference sample with 3 batches of reagents, each batch repeated 10 times, the color development results of parallel determination between 3 batches should be consistent and uniform.
Parallel determination of IgM enterprise repeatability reference sample with 3 batches of reagents, each batch repeated 10 times, the color development results of parallel determination between 3 batches should be consistent and uniform.
6. Interfering substance: Unqualified samples will lead to wrong results, such as the hemoglobin in the hemolysis sample >6g/L, triglycerides in hyperlipidemia samples >15g/L, bilirubin in jaundice samples > 0.2g/L,RF > 1200IU/mL in rheumatoid samples.
7. Cross reaction:The kit has no cross reaction against human immunodeficiency virus antibody, hepatitis B surface antibody, hepatitis C virus antibody, treponema pallidum antibody, mycoplasma pneumoniae antibody, helicobacter pylori antibody positive samples.
8. Clinical sample compliance:A total of 523 clinical samples were tested for validation, of which 142 were positive and 381 were negative.
| NewScen |
Clinical sample information |
Total |
| Positive |
Negative |
| Positive |
A |
129 |
B |
0 |
A+B |
129 |
| Negative |
C |
13 |
D |
381 |
C+D |
391 |
| Total |
A+C |
142 |
B+D |
381 |
A+B+C+D |
523 |
Positive coincidence rate:
A/(A+C)% = 90.85%(95% credibility interval: 84.85%～95.04%
Negative coincidence rate:
D/(B+D)% = 100.00%(95%credibility interval: 99.04%～100.00%
Total coincidence rate:
(A+D)/( A+B+C+D)% = 97.51%(95%credibility interval: 95.79%～98.67%)
INDEX OF SYMBOLS
bio-equip.cn
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits:
Rapid Tests for Human Use :
1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH
2) Infectious diseases: Hepatitis B, HCV, HIV
3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC
4) Tumor markers: CEA, PSA, AFP, FOB
5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia
6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc.
Rapid Tests for Veterinary :
1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test
2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus
3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
Rapid Tests for Food Safety :
1)For Antibiotics Residue : Nitrofurans (AOZ,AMOZ, AHD, SEM), Streptomycin , Sulfonamides , Chloramphenicol , Quinolone , Beta-Lactam&Tetracycline Combo (2 in 1), β-Lactams & Streptomycin & Chloramphenicol & Tetracyclines Combo (4 in 1), Beta-Lactam, Tetracycline test
2) For Beta-Agonist Residue : Ractopamine, Clenbuterol ,Salbutamol
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