Intended use:
AIVD COVID-19(SARS-CoV-2) IgG/IgM Rapid Test is a single use, rapid device for qualitative detection of total antibodies against 2019 novel coronavirus (SARS-CoV-2) in human serum, plasma or whole blood specimens. The kit is intended for screening of patients suspected for infection with SARS-CoV-2, and as an aid in the diagnosis of the coronavirus disease 2019 (COVID-19).
Descriptionï¼?
Novel coronavirus pneumonia (NCP) or SARS-COV-2, that was officially named by the WHO as â??Corona virus disease 2019â?? (COVID-19), is a respiratory infection caused by a new virus that was first identified in late 2019.
IgM/IgG Rapid Kit can specifically detect IgM and IgG antibodies of COVID-19, covering the entire course of infection and recovery period of patients. This approach improves the overall diagnosis of COVID-19 in both acute and recovery phases of illness.
This kit utilizes the principle of colloidal gold immunochromatography to qualitatively detect the new coronavirus (COVID-19) IgG / IgM antibodies in human serum and plasma. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients.
This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well, and then add the required amount of a diluent. The IgG / IgM antibodies in the sample will interact with the colloidal gold-labeled COVID-19 recombinant antigen on the conjugate pad. Then the conjugate pad will release re-solubilized conjugate onto the nitrocellulose membrane. The nitrocellulose membrane (NC membrane) diffuses it forward.
As the sample moves along the device binding reagents situated on the nitrocellulose membrane bind to the target at the test line. If the sample contains a COVID-19 IgG antibodies, they will bind to the colloidal gold-labeled novel coronavirus recombinant antigen, diffuse forward, and then react with the anti-human IgG antibodies immobilized on the NC membrane detection line (T2 line). Similarly, if the specimen contains IgM antibodies to COVID-19, the antibodies will react with antigen-coated particles, the conjugate migrate laterally forward, and cause a colored line (T1 line). The darker the color of colloidal gold on the test line, the higher the concentration antibodies to COVID-19 in the sample.
Accuracy:ï¼?> 90%
Specificity: 97%
Basic Protocolï¼?
1. Remove the test specimen, required reagents from storage conditions, and equilibrate to room temperature.
2. Unpack the aluminum foil bag, place the test horizontally on the table and number it.
3. Add 10ul serum, plasma or whole blood sample to the sample well with a pipette or a dropper. Slowly add 2 drops of sample dilution (about 60uL) to the sample well.
4. Read the results within 10-15 minutes after adding the sample, and the results will be invalid after 30 minutes.
INTENDED USE
For qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection.
FEATURES
Coated with carefully selected specific Nucleocapsid and Spike protein antigen.
Detection for IgM and IgG antibodies simultaneously.
Simple operation, easy result interpreted.
Rapid test within 15 minutes.
RESULTS INTERPRETATION
Positive:
1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies.
2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody.
3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody.
Negative:
1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative.
Invalid:
1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested.
2. The test result is invalid after 15 min.
We are manufacturer and supplier of high quality molecular diagnostics product among covid 19 detection kits consisting of:
1]. covid 19/sars cov 2 nucleic acid test kits to detect the covid 19 standard, uk and south africa variants (rt pcr).
2]. covid 19/sars cov 2 antigen rapid test kits.
3]. covid 19/sars cov 2 antibody (igg/igm) rapid test kits.
in addition to a product of quality, we offer very competitive price and we have high production capacities to assure a continuous supply of product without shortage..Manufacture, oem
[Intended Usage]
This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites.
[Storage Conditions & Validity]
1. The kit should be stored frozen at -20 and protected from light; the expiration date is 6 months; the production date and expiration date are shown in the outer packaging box.
2. Avoid repeated freezing and thawing of the kit and the number of freezing and thawing shall not exceed 7 times.
3. After opening, the bottles should be stored at -20 and protected from light. The number of bottles opening times should not exceed 7 times, which will not affect the use within the validity period.
[Applicable Instruments]
1. This kit has been validated on ABI7500 quantitative fluorescence PCR instrument.
2. For other models not listed, relevant experiments have not been performed or completed for this kit. If users need to use this type of instrument platform to carry out the detection of this reagent, please contact our Technical Department at for relevant support.
NB: The other devices can include quantitative fluorescence PCR platforms with FAM, VIC, ROX and Cy5 channels.
[Sample Requirements]
1. Nasopharyngeal swabs, oropharyngeal swabs and other methods are used to obtain samples, and it is recommended to use commercial virus sampling kits for sample collection devices.
[Test Results Interpretation]
1. Negative and positive controls should be tested in each experiment and the test result can be determined only when the controls meet the quality control requirements.
2. When FAM, VIC and ROX channels are positive, Cy5 channel result may be negative due to the system competition.
3. When the internal standard result is negative, if the FAM, VIC and ROX signals of the test sample are also negative, the test result of the sample is invalid, and the cause should be found and eliminated, and the experiment repeated for this sample.
[Product Performance Index]
1. Precision: The coefficient of variation Intra-batch / Inter-batch, Intra-day / Inter-day among different operators shall not be higher than 5.0%.
2. Coincidence rate of negative positive controls: The coincidence rate of positive controls and negative controls is 100%.
3. Minimum detection limit: The minimum detection limit of this kit is 500 copies/mL.
For in vitro qualitative detect of Covid-19 antigen in nasal(NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days of the onset of the symptoms. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.
1.Easy to collect samples simple operation without professional equipment.
2.The test results are available in 15 minutes, and the test results are clearly visible. 3.Convenient transportation and low price, higher accuracy.
4.Suitable for large-scale rapid screening.
Shelf life: 24 Months
Test Result time: 10 Mins
Packing: 25 Pieces per Box
5852 Covid 19(Sars Cov 2) Igg Igm Rapid Test Suppliers
Short on time? Let Covid 19(Sars Cov 2) Igg Igm Rapid Test sellers contact you.
Cat. No : 5513C. COVID-19 serology test.Cellex qSARS-CoV-2 IgG/IgM Rapid Test.qSARS-CoV-2 IgG/IgM Rapid Test Cassette.FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19
SARS-CoV-19 IgG/IgM test kit (15min showing result)
Manufacturer: Guangzhou Wanfo Biotech Co., Ltd. a China listing company
Certificates: CE certificate, China NMPA approval (export allowed), no FDA approval
The price is $5.5/test (FOB)
Max delivered quantity: 100,000/weekly
More details please enquire Barry Liu whatsapp: +8617810331113
sample available: 20 test & DHL delivery: $200
Download introductions: https://kdocs.cn/l/sLLC9O6rc
INTENDED USE
For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection.
FEATURES
Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2.
Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva.
Easy to use, easy results interpretation by naked eyes.
Test result available within 15minutes.
TEST PROCEDURE: Very simple as per the instructions stated on the manual inserted in the kit.
RESULTS INTERPRETATION
Positive: A red line appears on the test line (T) and the control line (C).
NOTE: A positive result does not rule out co-infections with other pathogens.
Negative: Only the control line (C) appears, and no red line appears on the test line (T).
NOTE: A negative result does not exclude infection.
Invalid: There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again.
- LoD: 1.5�??102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen.
- Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable.
- No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track.
- Positive Agreement (95% CI): 97/100, 97% (83.3% - 99.9%)
- Negative Agreement (95% CI): 100/100, 100.0% (95.5% - 100%).
[Product Name]: SARS-CoV-2 Antigen Test
[Product Code]: Cat# FP-318
[Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva
[Detection Method]: Colloidal Gold
[Reaction Time]: Within 15min
[Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1.
[Storage Conditions]: 2*C ~ 30*C
[Shelf Life]: 12 months
[CE Mark Registration No.]: RPS/99/2021.
FAST: Results in under 2 minutes
ACCURATE: 99.9% specificity and 98.7% sensitivity
EASY TO USE: Convenient for testing at home
PAINLESS: Simple and painless saliva collection
RELIABLE: 24-Hour RT-PCR Confirmation (100% specific and 100% sensitive)
99.9% specificity.
Test specificity this high ensures that almost all the people who are not infected get a negative test result with the Sensiva React Rapid Covid-19 Testing Kit. Using a fast and accurate test such as this one is vital when we are trying to stop virus transmission and protect general health.
98.7% sensitivity
Test sensitivity refers to the percentage of infected people who get a positive test result. In our case that means that 98.7% of people with an infection get a positive test result.
How to use it?
Step 1 â?? Do the test
Sensiva React Rapid Test is a simple test that can be� easily done at home. It is convenient and� painless� since it requires you to collect a saliva sample instead of a nasal swab. How to do it? First, use the mobile application to scan the QR code to register. After that, collect a saliva sample and add it into the saliva hole in the reader device before adding the liquid solution. You will be able to interpret your� results in under 2 minutes. Watch a video with detailed instructions on how to do the test in the video below. Please follow the instructions carefully to obtain a valid test result.
Step 2 â?? Get RT-PCR confirmation in 24 hours
You can use the prepaid shipping label and send the saliva sample used for the rapid test to us. You will get an official PCR result (100% sensitivity and 100% specificity) in 24 hours. Our lab is certified under the Clinical Laboratory Improvement Amendments (CLIA), so you can rely on us to provide you with accurate and reliable test results.
Who is Sensiva React Rapid Covid-19 Test for?
Sensiva React Rapid Covid-19 Test is designed for patients with COVID-19 symptoms or those who are asymptomatic but suspected of having exposure. Its easy-to-follow instructions make it convenient for testing at home.
The kit contains:
(1) Specimen Tube
(1) Saliva Funnel
(1) Dropper
(1) Bio-hazard bag with absorbent pad
(1) Lateral flow device
(1) 5ml EZ-Tear Saline Solution
(1) 0.3ml EZ-Tear Buffer Solution
(1) Written Instruction Card
Product Details:
Number of Reactions(Preps)/Kit ; 25
Brand : Cellex
Test Method : (SARS-CoV-2) IgM/IgG Rapid Antibody
Result Time (Rapid Kits) 30 minutes
Time To Result 15 mins
Cat. No : 5513C
COVID-19 serology test.Cellex qSARS-CoV-2 IgG/IgM Rapid Test.qSARS-CoV-2 IgG/IgM Rapid Test Cassette.FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19
Corona viruses are enveloped RNA viruses that are distributed broadly among humans, birds and other mammals, that cause respiratory, enteric, hepatic, and neurologic disease.
SPECIFICATIONS:
Whole blood/serum/plasma may be used for testing.
Results available in only 15 minutes.
Easy to use.
Result can be read visually.
No need for an analyser.
Cost effective method for assisting in screening COVID-19 disease.
Anti-SARS-CoV-2 Rapid Test, COVID-19
1. Easier: No special equipment needed, Intuitive visual interpretation.
2. Rapid: Quick sampling by fingertip blood, Results in 10-15min.
3. Accurate: Results with IgG and IgM respectively.
4. Application: as screening tool for potential suspect patients in large numbers.
Testing kit is FDA Emergency Use Authorization (EUA) Approved
Testing kit is CE MARKED-IVD
* Instruction for Use
* Interpretation Guide
* SARS-CoV-2 immunoassays
* Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit
* Anti-SARS Rapid Test Brochure
* COVID-19 Catalog
* EUA Approval Letter
* Fact Sheet for Healthcare Providers
* FDA Letter
* Fact Sheet for Recipients
* FAQ
* CE IVD Notification Certificate
* Instruction for Use
* Interpretation Guide
* SARS-CoV-2 immunoassays
* Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit
* Anti-SARS Rapid Test Brochure
* COVID-19 Catalog
* EUA Approval Letter
* Fact Sheet for Healthcare Providers
* FDA Letter
* Fact Sheet for Recipients
* FAQ
* CE IVD Notification Certificate
AIVD Biotechs COVID-19 Ag test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein (NP) antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19.
Description
This kit utilizes the principle of latex bead immunochromatography to qualitatively detect the new coronavirus (COVID-19) Np antigen in human nasal swabs. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients.
The test contains latex bead conjugate pad and a membrane strip pre-coated with antibodies specific to SARS-CoV-2 antigen on the test lines (T). If SARS-CoV-2 antigen is present in the specimen, a visible band appears on the test lines (T) as antibody-antigen-antibody latex bead complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly.
This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well. If sample contains the antigen, it will interact with the latex bead-labeled COVID-19 anti-SARS-COV-2 NP antibodies on the conjugate pad.
Required components
1. A foil pouch with a desiccant and a single-use test card, 1 piece
3. Sterile swab, 1 piece
3. Extraction buffer tube (1 ml), 1 tube.
4. Instructions for use, 1 piece.
Specimen requirements:
1. Nasopharyngeal swab specimen.
2.Specimen should be tested as soon as possible upon collection. If the sample has to be stored, store the swab sample at room temperature for up to 1 hour or 2~8â?? for up to 4 hours prior to testing.
Specimen preparation
1. Insert the extraction buffer tube into the tube rack, make sure that the sample tube is firmly upright and touches the bottom of the rack.
2. Insert the swab into an extraction buffer tube.
3. Gently stir the swab in the tube, and then left swab inside the tube for 1 minute or Mix on the vortex mixer for about 30 seconds,
4. The sample should be tested immediately after collection.
If it cannot be tested in time, it should be stored in the virus transport matrix. The specimens can be stored at 2-8C for 4 hours
Basic Protocol
Step 1: If the sample is refrigerated, remove the sample to be tested and the required reagents from the storage conditions, equilibrate to room temperature (15~30C)
Step 2: When preparing to test, open the aluminum foil bag, take out the test card, and lay it flat on a table.
Step 3: Mark the sample number on the test card,
Step 4: Using pipette add 50ul of the sample into a sample well on the device,
Step 5: Read the result within 15 minutes,
Please read the result after 15 minutes. After observing and recording the result, please discard the test card to avoid affecting the result judgment.
Do not read test results after 30 minutes. It may give false results.
Offering Safecare3 Covid 19 antigen + A+B flue, 1:3 combo tests, single packed, self testing, 2 years self time from my warehouse in Vilnius, Lithuania.
Our COVID-19 rapid test kit can be used effectively on many levels for proper screening and strategic preparedness toward the pandemic. The test kit requires no sophisticated equipment nor laboratory settings. Our SARS-COV-2 Antibody Rapid Test Kit can be applied for screening of COVID-19 disease on the following:
General practitioners and external clinics level to detect previous SARS-COV-2 viral infections on both symptomatic and asymptomatic patients.
Determination of the immunity level of front-line healthcare workers, which can help in the development of pandemic preparedness strategies at national levels.
Epidemiological COVID-19 surveys at national and district levels for research purposes.
Airport screening for arriving /departing passengers to control the pandemic in the aviation industry.
Suspected cases exclusion to minimize cost and time spent in the RT-PCR testing procedures.
Screening on the national level to facilitate decision making regarding lockdown and curfew easing strategies.
Phoenix Bioscience is offering a competitive price for a high-quality kit that is made in Canada and used currently to combat the pandemic in most American cities.
Our SARS-CoV-2 IgM/IgG Antibody Test Kits are single-use rapid immunochromatographic tests for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, dipotassium EDTA, and sodium citrate), and venous whole blood (heparin, dipotassium EDTA, and sodium citrate). They are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
INVBIO Covid Antigen Ag saliva rapid test card
Sensitivity: 97.1%
Specificity: 99%
Agreement: 99.57%
10 miuntes to get the result. MOQ for each: 500 tests, 25 tests/box,
