For in vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days after onset of symptoms.
This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, not for at-home testing.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease (COVID-19), which is contagious in humans. SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N).
The antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results should be treated as presumptive, which do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.
For in vitro diagnostic use only. For professional use only .
Lateral flow assay
No equipment required
Rapid results within 10 minutes
Minimally invasive specimen collection (nasopharyngeal swabs)
POC setting (i.e. in patient care settings) by medical professionals
Detects SARS-CoV-2 nucleocapsid protein antigen with ultra high performance
Identify acute infection wit 88.4% sensitive and 100% specificity
20 test/box
20 test devices
20 assay buffer
20 extraction vials and caps
20 specifimen collection swabs
1 positive and 1 negative control swabs
1 instructions for use
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%.
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We Supple Grade A medical examination Disposable Covid-19 test kit and Syringes with affordable prices in major international market free to contact us for more Quotation.
An established PCR test kit that has had exceptional results both in the lab and in real world settings with major countries reporting sensitivity results. The PCR is the first Korean test kit to receive FDA, EUA, and CE approval, allowing this test kit to be sold globally without restrictions. We are able to secure ample volume reliably.
South Korea-based RapiGEN is a leading manufacturer of in vitro diagnostic industry. The company has developed and manufactured rapid diagnostic test devices for over 15 years. RapiGEN's core raw material, black gold particle, has brought innovation to the in vitro rapid test field with their high specificity, sensitivity, and reproducibility.
Ionebio produces the iLAMP Novel-CoV19 Detection Kit, a real-time Reverse Transcription LAMP-PCR assay system. The test kits are widely used in South Korea, including at ports of entry into the country. Ionebio has secured a facility in the United States which can produce 1 million test per day. This PCR has a 20 minute test time.
NAME COVID-19 Nucleic Acid Detection Kit(PCR-fluorescent Probe)
USE Diagnosis COVID-19 rapidly for public disease control
Manual Biological cabinet, Appropriate real time PCR instrument, Appropriate nucleic acid extraction system or kit, Desktop centrifuge ( suitable for 96- well plate or 8-strip tube), Centrifuge with a rotor for 0.2ml reation tubes or plate. Vortex mixer, Adjustable piperres(with maximum capacity of 2 L, 10L, 50L, 100L, and 200L, respectively), Disposible pipette tips with filters, Disposable powder-free gloves, RNase FREE 1.5mL centrifuge tube, PCR reation tube / PCR reaction plate.
Storage and Transportation Store in -20 - 5 and transport with carbon diaxide ice, avoid being repeated freezing and thawing.
Expiration date 9 months
* Please be noted the above is the price including the tax, NOT FOB.
Diagnostic Kit for IgM/IgG 2 in 1 Antibody to 2019-nCoV (Colloidal Gold)
Test principle
This diagnostic kit adopts the principle of colloidal gold immunochromatographic test strip to make qualitative test for 2019-nCoV IgM/IgG antibody in human serum, human plasma and whole blood samples.
Purpose
This diagnostic kit is used for making qualitative test for 2019-nCoV IgM/IgG antibody in human serum, human plasma and whole blood samples. It acts as an early-stage aided diagnostic kit for clinical patients infecting 2019-nCoV, yet it is not the only standard for clinical diagnose.
Sample requirements
This kit is suitable for human serum (EDTA anticoagulant, heparin anticoagulant, trisodium citrate dihydrate anticoagulant 1:9), human plasma and whole blood samples.
Purpose
This test kit is used for making qualitative test for COVID-19 antigen in human nose swab and throat swab samples. It acts as an early-stage aided diagnostic kit for clinical patients infecting COVID-19, yet it does not stand for the basis for confirming COVID-19.
Sample requirements
When using sterile swab for collecting samples, polyester sponge swab with PP bar is recommended when collecting nose swab and throat swab. When collecting nose swab, the swab will be gently inserted into the nose palatine and stay for a moment, and then gradually rotate it until it is taken out. When collecting throat swab, the swab will be completely inserted into the throat from the mouth, then inspectors will wipe pharyngeal tonsil on both sides and posterior wall of pharynx with appropriate strength, and finally take the swab out. During this process, please avoid touching the tongue. After collecting the samples, please make processing with viral transport medium or sample diluent provided in the test kit as soon as possible, and complete test within five minutes.
Test principle
This test kit adopts the principle of high-specificity antigen-antibody reaction and colloidal gold labelling and immunochromatographic test strip techniques. The reagent contains COVID-19-NP antigen monoclonal antibody pre-fixed in film test area and COVID-19-NP antigen monoclonal antibody-colloidal go
hrough market research and government trading department internal documents, we have complied a covid-19 related products suppliers contract info.
The data consists of product introduction (including description and certification) and main markets they export. Supplier�¢??s name and contact person phone number. All the contract person are the one who directly responsible for international selling, and the phone number is her/his direct mobile phone. 100% accurate and updated at the end of March 2020
The data consists of 6 categories
1. Diagnostic reagent supplier (eg. Covid-19 test kit etc.)
2. Medical equipment (like ventilators etc.) supplier
3. Chinese patent medicine supplier
4. AI-aid diagnostic system supplier
5. Temperature measuring device supplier (eg. Thermometer etc.)
6. Disinfection equipment (eg irradiation system and disinfection gel, hand wash etc.)
7. Protective clothing
Each categories price: USD 100
Full package of seven categories: USD: 600
Coronavirus Ag Rapid Test Cassette (Swab)
have been placed on the European Market, based on the following performance characteristics (which are also included in the IFU included in each test kit)
Coronavirus Ag Rapid Test Cassette (Swab)
Method
Coronavirus Ag Rapid Test Cassette
Total Results
Relative Sensitivity: 86.7% Relative Specificity: 100% Accuracy: 96.3%
Coronavirus Ag Rapid Test Cassette (Swab)
The CE mark has been applied as the products fit the definition of an in vitro diagnostic medical device as defined in the IVD Directive and are classified as a general IVD products as they are not included in List A or List B, and they are not intended to be used by lay users.
Please note that this
CoVirion-CV19-2 SARS-CoV-2 OneStep RT-PCR kit is a probe-based Real Time PCR test designed for the qualitative detection of SARS-CoV-2 Coronavirus, the etiological agent of COVID-2019. It is used to detect N-gene and S-gene in viral RNA.
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