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 .
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%.
A rapid test for the qualitative detection of novel coronavirus antigens in nasal, Nasopharyngeal (NP) swab & Oropharyngeal (OP) swab.
The S2 Covid-19 Rapid Antigen Test Kit (swab) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in Nasal swab, Nasopharyngeal swab (NP) and Oropharyngeal swab (OP), using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen.
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.
This antigen test is suitable for the qualitative detection of novel coronavirus in Saliva/Sputum/Stool/NP Swab/OP Swab samples (all methods in single test). Result in 15mins
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
Bacterial Vaginosis Rapid Test Kit core Chromogenic Ingredient IBX-4041
IBX-4041 Testing vessel
BV Blue active ingredient
BVBlue active ingredient
BVBlue substrates
BV Blue substrates
Chromogenic substrate IBX-4041
chromogenic substrate of sialidase enzyme
Detection reagent for bacterial vaginosis (sialidase two-step method)
Shenzhen BST Science & Technology Co., Ltd sells and exports chromogenic substrate of sialidase enzyme IBX-4041.
Specification:
Appearance: Light yellow solid powder
Purity: 95% min
Application: Two-step chromogenic substrates of neuraminidase (sialidase)
BVBLUE Test Kit Component
1)BVBLUE Developer Solution: Water and Sodium hydroxide
2) BVBLUE Testing Vessel: Water, Potassium acetate, IBX-4041 (chromogenic substrate compound).
IBX-4041 is the key ingredient of BVBLUE test kit, BVBLUE test is a rapid sialidase test for bacterial vaginosis. BVBLUE test method is currently the only test method approved by the FDA for testing Bacterial Vaginosis(BV), The BV BLUE Test contains a chromogenic substrate of sialidase enzyme, IBX-4041.
BV Blue test is a commercially available test, it detects sialidase activity, an enzyme produced by BV-associated bacteria such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp. In the test procedure, a vaginal fluid sample is placed in the test vessel which contains a chromogenic substrate for sialidase. After incubation, a developer solution is added, and If the sample contained a high level of sialidase, a blue or green color is seen. Samples containing no sialidase, or low levels of this enzyme, will generate a yellow color in the reaction. The BV test has high specificity and sensitivity. The BVBlue test enables rapid detection of BV in a physician's office, and can thereby provide advantages over the Amsel methods and other methods requiring extensive laboratory testing.
Advantage of BVBLUE Test Kit
Compared to other diagnostic test methods for BV such as Amsel criteria, Nugent Gram-stain scoring system, Affirm�® Microbial Identification Test, BVBLUE Test Kit has following advantage:
1, BVBLUE Test is currently the only test method approved by the FDA for testing Bacterial Vaginosis(BV).
2, BVBLUE Test just take 10 minutes to 15 minutes to get the result.
3, High purity sialidase substrate with high specificity can reduce the occurrence of false positive.
4. Comparing with the gold standard, the coincidence rate is high, the relative sensitivity is 93%, and the specificity is 95%.
5. Easy to operate, do not need equipment.
6. The specimen does not need to pretreat.
The One Step Microalbumin Test Cassette (Urine) is intended for the qualitative detection of human serum albumin (HSA) in human urine specimens, as a screening test and as an aid in the diagnosis of renal dysfunction. This assay provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test.
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