The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG antibody immobilized in G test area, mouse-anti human IgM antibody immobilized in M test area and the corresponding antibody in quality control area (C).
During the test, when the SARS-CoV-2 IgM antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgM antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgM antibody immobilized in M test area subsequently and this produces a purple-red band appears in the M test area. When the SARS-CoV-2 IgG antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgG antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. Theconjugates migrate upward through capillary effect and would be captured by mouse-anti human IgG antibody immobilized in G test area subsequently and this produces a purple-red band appears in the G test area. If it is a negative sample, there is not a purple-red band appeared in the M and G test area. Regardless of the presence or absence of the SARS-CoV-2 antibody in the sample, a purple-red band will appear in the quality control area (C). The purple-red band in the quality control area (C) is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as the internal control standard for reagents.
SARS-CoV-2 IgG/IgM Rapid Test Kit
Intended Use: To detect IgM and IgG antibodies against N and S protein of SARS-CoV-2 in whole blood, serum and plasma
Product Format:Â 25 tests/kit
Kit Contents: test card, diluent, capillary, lancet, and instruction for use.
Storage/Stability: 2 C to 30C for 12 months.� eproducibility /Precision
100% Concordant across 3 lots with CV ±5%
Performance Comparison (A)
China Validation Test
Positive Samples 100 / 102
Sensitivity: 98.04%
Negative Samples 491/492
Specificity: 99.80%
Overall Accuracy: 99.49%
Performance Comparison (B)
Positive Samples 23 / 25
Sensitivity: 92%
Negative Samples 25 / 25
Specificity: 100%
Overall Accuracy: 96%
SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal swab samples)
SARS-CoV-2 Antigen Rapid Test Saliva)
We have two fast screening reagents for routine detection. One is the antibody iggigm detection reagent (that is, blood for three minutes) One is antigen rapid screening test reagent (the same is three minutes can use nasal mucosa, oral mucosa, and saliva three detection methods) 1.SARS-CoV-2 antigen testing can detect infection earlier than antibody testing 2.SARS-CoV-2 antigen testing can detect SARS-CoV-2 and all mutant virus strains 3.Easy operation and quick results 4.The result is clear. C-line and T-line determines the infection and the result is easy to read 5.The colloidal gold method has stable performance and is not interfered by environmental and experimental conditions 6.Application: for human throat swab , nasal swab and sputum extract Our test kits for COVID-19 as below are still effective to detect the infection of new COVID-19 variant B.1.1.7and The new variant has no effect on the detection performance of products
The PocRoc SARS-CoV-2 Neutralizing Antibody Rapid Test Kit is developed for in vitro qualitative detection of SARS-CoV-2 neutralizing antibodies in human serum, plasma, or whole blood samples.
SARS-CoV-2 Neutralizing antibody is an important marker for assessing the effectiveness of the SARS-CoV-2 vaccines. The reagent is for neutralizing antibody detection in samples from individuals after vaccine injection or recovered from COVID-19. PocRoc�® SARS-CoV-2 Neutralizing Antibody Rapid Test Kit has great significance for the development of SARS-CoV-2 vaccines, evaluation of effectiveness, and evaluation of neutralizing antibody levels in human bodies.
For Medical Professional Use Only!
TEST PROCEDURE
Do not open the sealing strip until you are ready to perform a test, and the single-use test is suggested to be used under a low environment humidity (RHâ?¤70%) within 1 hour.
1. Allow all the components of the kit and specimens to reach room temperature prior to testing.
2. Take out the test card and place it on a clean dry surface.
3. Identify the test card for each specimen.
4. Use a dropper to deliver one drop (~40�¼l) of serum, plasma, or whole blood samples into the sample well on the test card, followed by one drop (~40l) of sample buffer.
5. Start the timer and read the result immediately after 15 minutes, and the result after 30 minutes is invalid.
TBG SARS-CoV-2 Neutralizing Antibody Qualitative Rapid Test(colloidal gold) Now with the detection before and after vaccination, TBG''s company has a neutralizing antibody detection reagent, that it can be used as the effective rate detection of antibody before and after vaccination. No matter how the vaccine is administered, The Neutralizing Antibody Qualitative Rapid Test will be used. Our test kits for COVID-19 as below are still effective to detect the infection of new COVID-19 variant B.1.1.7and The new variant has no effect on the detection performance of products
AbChek (SARS-CoV-2) IGM/IGG Corona Rapid Antibody Test Kit
Product Details:
Number of Reactions(Preps)/Kit : 50
Brand : AbChek
ICMR(Govt) Approved : Yes
Test Method : (SARS-CoV-2) IgM/IgG Rapid Antibody
Result Time (Rapid Kits) : 5-10 minutes
Sample Type : Blood
Type : Rapid Test Kit
Sensitivity : 98
Packaging Size : 50 Tests/ Box
Country of Origin : Made in India
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.
Additional Information:
Item Code: RapidTestcov19
Production Capacity: 100000
Delivery Time: 10 days
Packaging Details: Carton Box
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
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.
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.
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.
1. Nasopharynx swab specimen, non-invasive
2. Very simple to use
3. Convenient, no devices required
4. Rapid, results within 20 minutes
5. Cost-efficient
6:Listed on German BfArm ,got approval by PEI
Clinical report from local CDC
Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.
Content of each kit: Test card (innovative and unique system), detailed instructions for use, sterile disposable swab, reactive solution for sample treatment, illustrative manual for use and operation.
General characteristics: CE self-diagnostic certification, holographic security label with individual code for authenticity verification, non-invasive, easy to use, no prescription required, rapid results in less than 15 minutes, high precision.
Sale restrictions: Exclusive sale to pharmacies, authorized companies, pharmaceutical distribution, socio-sanitary establishments, health establishments, occupational risk prevention, public organizations and health professionals.
Restricted sale to individuals. Sale subject to the provisions of Royal Decree 588/2021, of July 20, which modifies Royal Decree 1662/2000, of September 29, on medical devices for "in vitro" diagnosis, in order to regulate the sale to the public and the advertising of covid-19 self-diagnosis products. Sale subject in relation to tax matters to the provisions of Royal Legislative Decree 35/2020, of December 22, seventh final provision. Applicable tax rate of Value Added Tax to deliveries, imports and intra-community acquisitions of certain goods and provision of services necessary to combat the effects of SARS-CoV-2 as well as for the purposes of the special regime of the equivalence surcharge .
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