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 .
COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit Principle: based on Colloidal Gold Method, to detect COVID-19 IgG/IgM Antibody in serum, plasma, whole blood qualitatively. Easy to operate, results can be obtained in 15 minutes. Component: 25 tests cassttes/ 25 dropper/ 25 tubes of dilution buffer/25 Alcohol pad/ 25 Lancet/ 1 manual Certificate: CE, ISO13485, ISO9001
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.
RAPIGEN 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 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
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.
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.
REF - L031-11815 Format - Cassette 3.5 mm Finished or Bulk - Finished in kit box Kit Size - 25 Carton Size - 800 pouches (32 kits) Carton Size (mm) - 530*445*410 Gross weight per carton (kg) - 13.2 quantity per carton - 800 Carton # - 1,250.00 Order quantity (pcs) - 1,000,000 Order gross weight (kg) - 16500 Order total volume (cbm) - 120.873
REF - L031-125V5 Format - Cassette 3.5 mm Finished or Bulk - Finished in kit box Kit Size - 5 Carton Size - 600 pouches (120kits) Carton Size (mm) - 520*395*440 Gross weight per carton (kg) - 10.55 quantity per carton - 600 Carton # - 1,666.67 Order quantity (pcs) - 1,000,000 Order gross weight (kg) - 17583 Order total volume (cbm) - 150.627
Product Description The iHealth COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. Pricing: $5.5 PER KIT OF 2 TESTS MOQ: 1 pallet: 84 cartons / 7560 boxes / 15,120 tests Maximum Quantity: Please inquire Shipping Information: 90 Packs per Carton, 2 Tests per Pack 1 pallet: 84 cartons / 7560 boxes 1100 lbs Per pallet Single Package Dimensions (LxWxH) 6.18 x 3.19 x 0.71 Inches Single Package Weight (lb) 0.13 Carton Dimensions (LxWxH) 13.1 x 11.8 x 10.8 Inches Carton Weight (lb) 12.8
Contains : 1 test cassete, 1 Lysis Buffer, 1 Sterile Swab, 1 Bio-safety bag, 1 instruction of use
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.
The IgM rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies in human serum to Rheumatoid Factor (RF) antigen. It is intended to be used as ascreening test and as an aid in the diagnosis of rheumatoid arthritis. Any reactive specimen with the RF IgM Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.
Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to monkeypox virus in human whole blood, serum or plasma. This test provides only a preliminary test result.
Our newly-developed monkeypox antigen rapid test kit by our R &D department is CE certificate
COV19/ FluA/ FluB Antigen Combo Rapid Test Kit (Colloidal Gold Method) Packing Specifications The kit is an in vitro immunochromatographic assay for the qualitative detection of Cov19, Influenza A and Influenza B virus antigens in human nasopharyngeal, oropharyngeal swab, and salvia samples. Cov19 is an acute respiratory infectious disease that humans are easily infected with. According to current epidemiological investigations, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main symptoms are: fever, fatigue, dry cough, in a few cases can appear nasal congestion, sore throat, myalgia and diarrhea. Influenza, often called the flu is caused by the influenza virus. It is a highly contagious viral infection of the respiratory tract that can be spread by coughing or sneezing. Influenza outbreaks occur every fall and winter. There are influenza A, B and C viruses. Influenza A viruses are more prevalent than influenza B and Cand causes more severe illness. Cov19 infection and Influenza virus infection have similar symptoms, such as fever, cough, etc. This kit can simultaneously detect the antigens of the three viruses and provides an easy workflow, short turnaround time, and rapid diagnosis of Cov19, Influenza A and influenza B virus infections using nasopharyngeal, oropharyngeal swab or salvia samples. The kit is an immunochromatographic assay,based on double antibody sandwich method to detect Cov19 and Influenza A/B virus antigens. This method does not require expensive medical instruments and consumables. After adding the extracted specimen to the sample well on the test cassette, Cov19, Influenza A/B virus antigens in the sample will interact with the colloidal gold-labeled anti-CoV-2 and Influenza A/B antibodies on the conjugate pads. 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 COV19 antigen, it will bind to the colloidal goldanti-CoV-2 Np monoclonal antibody, diffuse forward, and then react with the anti-CoV-2 Np monoclonal antibody immobilized on the NC membrane detection line (COV19 Test line). Similarly, if the specimen contains Influenza A/Influenza B antigens, the antigens will react with antibody-coated particles, the conjugate migrate laterally forward, and cause a colored lines (A, B linesrespectively).
Product Name Neutrophil Gelatinase-Associated Lipid Carrier Protein (NGAL)Test Kit (Immunofluorescence Chromatography) Purpose To detect the NGAL in human plasma/serum/whole blood in vitro quantitatively.For Professional Use only. Principles of Detection The NGAL Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing NGAL antibody conjugated with fluorescent microspheres and a control antibody (goat anti-chicken IgY antibody) conjugated with fluorescence microspheres, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with anotherNGAL antibody, and the C line is pre-coated with a control line antibody (chicken IgY antibody). NGAL concentration in specimen is positively correlated with the fluorescent density of the microspheres, after the measure and calculation of the quantitative fluorescence immunoassay analyzer, then the analyzer would calculate the concentration of NGAL according to the preset calibration curve in the machine and display the result, detection unit is ng/mL. C line should appear in any cases, which indicates the reaction system is effective. Reference range Reference value: 37-180ng/mL; The reference value is verified by referring to similar products on the market. Due to ethnic and regional differences, each laboratory can establish its own reference interval according to the actual situation.
Application For the detection of eye / nose / stool / rectal secretions or blood pathogens The most convenient and rapid diagnostic tool for canine distemper / canine parvovirus Feature High accuracy for monoclonal antibody capture target Good tools for antibody detection and disease diagnosis Easiest reagent to operate the test Quickly present the result Low testing cost Technical specification Technical Parameters for Rapid Canine Distemper Ag Test Kit Principle: colloidal gold lateral chromatography Test samples: eye / nasal secretions or blood Interpretation of time: 10-15 minutes Sensitivity: 98% Specificity: 97% Shelf life: 24 months Storage temperature: 4-28 Packing: 10 Test/ box Technical Parameters for Rapid Feline Parvovirus Ag Test Kit Principle: colloidal gold lateral chromatography Test samples: rectal / feces Interpretation of time: 10-15 minutes Sensitivity: 99% Specificity: 97% Shelf life: 24 months Storage temperature: 2-30 Packing: 10 Test / box
