Testing kit for New coronavirus (2019-nCOV) IgG/IgM antibody Rapid Test WB/S/P
Specifications
25 tests
Introduce
This kit uses the colloidal gold immunochromatographic principle to qualitatively detect novel coronavirus igg/igm antibodies in human serum, plasma, or whole blood. the sample to be tested was added to the sample hole of the test paper, and then added 2 drops of sample diluent. the igg/igm antibody in the sample combined with the recombinant new coronavirus antigen labeled with the colloidal gold on the binding pad formed complex. under the action of chromatography, it diffused forward along the nitrocellulose membrane (nc membrane). the nitrocellulose membrane was fixed with two detection lines (g line, m line) and one quality control line (c line). the g line was fixed with anti-human igg antibody for the detection of new coronavirus igg antibody; the m line was fixed with anti-human igm antibody for the detection of new coronavirus igm antibody; and the c line had quality control for the detection of the new coronavirus ig antibody.
If the sample contains a new coronavirus IgG antibody, then the antibody binds to the recombinant new coronavirus antigen labeled with colloidal gold, diffuses forward, and then binds to the anti-human IgG antibody fixed on the NC membrane detection line (G line). if the sample contains a novel coronavirus igm antibody, then the antibody binds to the recombinant new coronavirus antigen labeled with colloidal gold, diffuses forward, and then binds to the anti-human igm antibody fixed on the nc membrane detection line (m line). The darker the color of the colloidal gold accumulated on the detection line, the higher the concentration of the new coronavirus antibody in the sample. To monitor the effectiveness of the test card, set up a quality control line (line C), whether there is a detection line (line T), quality control line (line C) should be color, otherwise the test results are judged invalid.
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains:
GCMS manufactures COVID-19 antigen test kit, the GENEDIA W COVID-19 Ag which is listed on the EU common list, also with GMP and ISO certifications. GENEDIA W COVID-19 Ag is unaffected based on the in-silicon analysis of the mutations in the nucleocapsid (N gene) of Omicron viruses. Letter of statement is available upon your request.
To get over COVID-19 pandemic, especially the recent Omicron breakout, currently we are doing big promotions for three kinds of COVID-19 Ag kit. All are in stock and available right away.
1. Nasopharyngeal
2. Nasal
3. Saliva
Price and Minumum Quantity
Price FOB in USD: negotiable 0.8 to 1.8Minimum Order Qty: None Pieces
Production Capacity: 3,000,000/monthPackaging: 20 Tests/kit, 30 Kits/box, 12 Boxes/pallet
Sample: Available. Sample Cost Born By Supplier
Product Model And Origin
Brand: GENEDIAModel: 643G-S (Saliva)
Seller Code: Genedia w covid 19 agHS Code: 3002.15
Standards: Ce
Competitive Advantages
Allow wider testing with fast test time (10 minutes)
All necessary materials provided / no equipment needed
Sensitivity: 93.33%, specificity: 100%
Free sample. no moq. price is negotiable. customized packing.
Other Details
20 tests / kit
24 months from the date of manufacture
2 ~ 30c(35.6 ~ 86f) available for room temperature deliver
In stock. fast delivery.
1 x Instructions for Use Manual
40 x Test Cassettes
1 x Buffer
40 x Dropper
Covd-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and dierential detection of IgG and IgM antibodies to 2019 Novel Corona Virus in human whole blood, serum or plasma.
Specification.jpg
Product: Rapid Diagnostic Test Kit
Item: Corona Virus Test Kit
Specimen: Whole Blood/Serum/Plasma
Format: Strip/Cassette
Port of Loading: Shanghai
OEM and ODM: OEM/ODM Welcome
Shipping: By UPS, FEDEX, DHL, TNT, by air or by sea
Note: Store this product in a cool and dry place, avoid direct sunlight, stay away from places that children can contact, and avoid eye contact. If you have allergies to this product, please stop using and consult a doctor.
COVID-19 Corona Virus Rapid Test Kit11.pngCOVID-19 Corona Virus Rapid Test Kit12.png
Cat No: RK056-20. STANDARD Q COVID-19 IgM/IgG Combois a rapid Immunochromatographic assay for the qualitative dtection of specific antibodies to SARS-CoV-2 present in human Serum,Plasma or Whole Blood specimen.
Rapid testing for detection of IgM & IgG antibodies against SARS CoV-2
10 µl of specimen: Serum, Plasma & Whole Blood
Long term storage of 24 months at 2 - 30 C
Complementary to RT-PCR Test
Can be performed without extra equipment
CE Approved Covid-19 IgG/IgM Antibody Blood Test Kit can be used as an initial screening for qualitative and differential detection. Throughout testing the antibody of IgG and IgM immunoglobulins in human serum, plasma or blood, the test kit can show the result in a short time.
Relative sensitivity 96.00%(192/200)
Relative specificity 98.29%(806/820)
Accuracy 97.84% (998/1020)
Advantages
Fast detection: 10 minutes to interpret the result;
Easy to operate: no complex equipment required during test;
Sensitive: the product has a higher sensitivity than PCR Nucleic Acid
Global Network
Singclean@COVID-19 lgG/gM Test Kit has been sold to more than 50 countries in the worid, like Brazil, Chie,Polandï¼?spain, Bolivia, Greece, Lihuania, Ecuador, Ukraine and Turkey.
Precaution
It is worth noting that the result of Covid-19 IgG/IgM antibody blood test should not be used as the only evidence of Coronavirus diagnosis. Professional doctors and clinical findings are necessary if the result of antibody test is positive. Besides, the test kit should be operated by professionals only. Use by individuals may cause deviation in test results.
Limitation
False negative and false positive could happen. If the antibody is lower than the detection level, especially in the 7 days of the onset of symptoms, a positive patient may also be diagnosed as negative.
COVID-19 IgM/IgG Antibody Detection Kit (Colloidal Gold Immunochromatography) is suitable for the qualitative detection of COVID-19 by detecting SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. Common signs of infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. SARS-CoV-2 can be excreted through respiratory secretions or transmitted through oral fluids, sneezing, physical contact, and through air droplets
Covid-19 or commonly known as Coronavirus is a viral infection involving a patients upper respiratory tract. It is highly contagious and causes a severe lung infection which can be severely debilitating and sometimes fatal. Our test detects two types of antibodies to Covid-19 which appear from 2 to 21 days after infection. It is an invaluable test to diagnose people who have been sick for a few days or those who have recovered.
Salient Features of the Product
It is rapid immunoassay for qualitative detection of Covid-19 IgM and IgG antibodiesin
We are the authorized first vendor of ADTech!
KFDA CE approved,
FDA Pending
Price : Negotiable
Pre-Clinical Test Report
Accuracy
- In total samples 93.3% (14/15) - In positive samples 91.7% (11/12)
1. Pre-Clinical Test summary
1) Pre-clinical test is fulfilled by Domestic large clinical laboratory with ADTech COVID-19 IgM/IgG RAPID KIT
2) Tests are made by total 15 samples with 12 positive and 3 negative samples
3) Clinical Laboratory tested the sample with Immunofluorescence Analysis
2. Pre-clinical test result
1) Samples were tested by ADTech COVID-19 IgM/IgG RAPID KIT
2) Test result by ADTechs RAPID KIT
- 4 negatives and 11 positives results in 15 samples
3) Comparison between Immunofluorescence analysis and ADTechs RAPID KIT
- 14 test results are same(including negative and positive results) - 1 samples test result are different(Positive Negative by ADTech
SOFTEC COVID-19 IGG/IGM Antibody Test Kit (Single Pack)
The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatograpic immunoassay for the qualitative defection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of intection with Novel coronavirus.
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.
A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.For professional in vitro diagnostic use only.
INTENDED USE
The Strep A Rapid Test Strip (Throat Swab) is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
SUMMARY
Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigen that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis.1 Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.2 Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.3,4
The Strep A Rapid Test Strip (Throat Swab) is a rapid test to qualitatively detect the presence of Strep A antigen in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.
PRINCIPLE
The Strep A Rapid Test Strip (Throat Swab) is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. After the test strip is immersed into a specimen, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. This mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a colored line in the test line region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The Leishmania IgG/IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of the Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans in human serum or plasma. This test is intended to be used as a screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis. Any reactive specimen with the Leishmania IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
SUMMARY AND EXPLANATION OF THE TEST
Visceral leishmaniasis, or Kala-azar, is a disseminated infection caused by several subspecies of the L. donovani. The disease is estimated by the World Health Organization (WHO) to affect approximately 12 million people in 88 countries1. It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected animals. Though it is a disease for poor countries, in Southern Europe, it has become the leading opportunistic infection in AIDS patients2-3.
Identification of L. donovani organism from the blood, bone marrow, liver, lymph nodes or the spleen provides a definite means of diagnosis. However, these test methods are limited by the sampling method and the special instrument requirement. Serological detection of anti-L. donovani Ab is found to be an excellent marker for the infection of Visceral leishmaniasis. Tests used in clinic include: ELISA, fluorescent antibody and direct agglutination tests4-5. Recently, utilization of L. donovani specific protein in the test has improved the sensitivity and specificity dramatically6-7.
The Leishmania IgG/IgM Rapid Test is a recombinant protein based serological test, which detects antibodies including IgG, IgM and IgA to the L. Donovani. This test provides a reliable result within 10 minutes without any instrumentation requirements.
Testing kit for New coronavirus (2019-nCOV) IgG/IgM antibody Rapid Test WB/S/P
Specifications
25 tests
Introduce
This kit uses the colloidal gold immunochromatographic principle to qualitatively detect novel coronavirus igg/igm antibodies in human serum, plasma, or whole blood. the sample to be tested was added to the sample hole of the test paper, and then added 2 drops of sample diluent. the igg/igm antibody in the sample combined with the recombinant new coronavirus antigen labeled with the colloidal gold on the binding pad formed complex. under the action of chromatography, it diffused forward along the nitrocellulose membrane (nc membrane). the nitrocellulose membrane was fixed with two detection lines (g line, m line) and one quality control line (c line). the g line was fixed with anti-human igg antibody for the detection of new coronavirus igg antibody; the m line was fixed with anti-human igm antibody for the detection of new coronavirus igm antibody; and the c line had quality control for the detection of the new coronavirus ig antibody.
If the sample contains a new coronavirus IgG antibody, then the antibody binds to the recombinant new coronavirus antigen labeled with colloidal gold, diffuses forward, and then binds to the anti-human IgG antibody fixed on the NC membrane detection line (G line). if the sample contains a novel coronavirus igm antibody, then the antibody binds to the recombinant new coronavirus antigen labeled with colloidal gold, diffuses forward, and then binds to the anti-human igm antibody fixed on the nc membrane detection line (m line). The darker the color of the colloidal gold accumulated on the detection line, the higher the concentration of the new coronavirus antibody in the sample. To monitor the effectiveness of the test card, set up a quality control line (line C), whether there is a detection line (line T), quality control line (line C) should be color, otherwise the test results are judged invalid.
Storage
Stored at 4 to 30c and valid for 18 months.
After the aluminum foil bag is unsealed, please use it as soon as possible.
Sample
1. It is suitable for human serum, plasma and whole blood samples.
2. The samples should be used as soon as possible; if they cannot be used immediately, the serum / plasma samples should be kept at 2-8C for 5 days and -20C for long-term preservation; the whole blood samples should be placed at 2-8C to avoid hemolysis;
3.The sample contains a large amount of lipids, hemolysis or turbidity, do not use, so as not to affect the judgment of the results.
The test cassette is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.
Product Name:
Surplex(R)-COVID-19 IgM/IgG Rapid test
Product Description:
Surplex(R)-COVID-19 IgM/IgG Rapid test is a serology test intended for the qualitative detection of IgM and IgG antibodies of the novel coronavirus (the SARS-COV-2 virus) in human serum, plasma or whole blood. It is CE marked and approved in Brazil (ANVISA approved).
We are motivated to aggressively price our product and ready to send 20 tests (one box) to qualified buyers for evaluation, free of charge.
Price of product:
FOB USD $1.50 - $2.50 per test, volume dependent.
Product origin :
China.
Key Specifications/Special Features :
- Competitively priced and ready to ship in volume.
- Currently shipping in volume to Brazil.
- Highly accurate and specific - performance independently confirmed.
- Results ready in 15 minutes.
- Harmonization System (HS) Code: 382200.
- We provide a full support during regulatory application.
Minimum Order Size and Packaging details:
MOQ: Flexible.
Box of 20 or 50 test kits.
Storage: 2-30C.
Shelf Life: 10 months.
I am the manufacturer of COVID-19 RAPID TEST in China. The ACtest COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-nCoV-19 virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with nCoV-19 viruses. The product has obtained the CE certification and is on the list of government export permits. And has been exported to Thailand, the Philippines, Germany, Italy, Ecuador, South Africa and other countries.
Vannin Healthcare offers several effective COVID-19 tests:
SGTi-flex COVID-19 IgM/IgG (25 tests per kit)
STANDARD Q COVID-19 IgM/IgG Duo Test (40 tests per kit)
Anti-SARS-CoV-2 Rapid Test (50 tests per kit)
General Features
Can detect and differentiate between IgM and IgG antibodies
Convenient: no additional equipment necessary
Extremely fast: results in 10-15 minutes
Point-of-care testing
Allow rapid decision-making in high-stakes situations
Why our tests
Certified: CE-IVD marked, FDA-cleared, ISO 13485, Korea GMP-certified
Reliable: high clinical specificity and selectivity
Easy to interpret
Can detect antibodies even in asymptomatic patients
Vannin Healthcare Global offers various diagnostic and serology tests for identifying the presence of Severe Acute Respiratory Syndrome Coronavirus2 (SARS-CoV-2). SARS-CoV-2 is the virus that causes COVID-19 which means that its presence could indicate that a person has been infected.
There are two types of tests currently used to determine the presence of the virus:
To find out whether antibodies are present in an obtained sample (whole blood, plasma, or serum), serology tests are used. The presence of antibodies could indicate a past infection. And depending on the type of the immunoglobulins present, it could also determine the approximate time when the infection occurred.
After fighting a coronavirus, our bodies are likely to produce two classes of antibodies: IgM and IgG. In the case of SARS-CoV-2, both IgM and IgG are most likely to occur simultaneously within two to three weeks after a person's been infected. For a firmer diagnosis, Vannin Healthcare Global offers serology tests that check for both IgM and IgG antibodies.
Can detect and differentiate between IgM and IgG antibodies
Differentiating between the antibodies is crucial when it comes to providing proper medical advice to your patients. The appearance of IgM antibodies is the initial response of the organism fighting to suppress the virus. These antibodies could indicate that the patient is still infectious, and advising patients to self-isolate is the appropriate course of action. IgG antibodies can be detected in the blood sample usually within7-10 days after the onset of infection. If a patient has IgG antibodies, and no IgM antibodies, they have developed a temporary immunity to COVID-19.
No additional equipment necessary
The test design makes it a perfect choice for remote areas without access to fully-equipped laboratories. Simply obtain a blood sample from a patient, and add 10�µl into the appropriate place on the testing cassette along with three drops (90µl) of the buffer. The results will appear in 10-15 minutes.
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
This test has been authorized by the FDA under a EUA for professional use CLIA and CLIA WAIVED for Point Of Care.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This product is intended for professional use and not for home use.
FACT SHEET FOR HEALTHCARE PROVIDERS
This test has been authorized by the FDA under a EUA for use by authorized CLIA laboratories. This device is CLIA waived for point of care use for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
There should be a blue line in the control region (next to ) before testing, discard the device if there is no blue line.
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