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The HY-T COVID-19 Antigen Self-Test (Nasal Swab) is lateral flow assay designed for the qualitative detection of specific SARS-CoV-2 antigen in human anterior nasal swab specimen. It is intended to be used for the detection of SARS-CoV-2 virus infection. The results obtained should not be the sole determinant for clinical decision. The HY-T COVID-19 Antigen Self-Test (Nasal Swab) is intended for use for home self-testing. Platform: Immunochromatographic Assay Format: Cassette Detection Specific: SARS-CoV-2 antigen Specimen: Nasal swab Sensitivity: * 97.17% Specificity: * 100% Assay Time: 15-20 minutes Shelf Life: 18 months * Vs FDA Emergency Use Authorized real-time RT-PCR Suitable for: Individuals who wish to know their status on COVID-19 infection (symptomatic and asymptomatic regardless of their vaccination status)Individuals who have had close contact with COVID-19 positive patientsIndividuals with suspected exposure to coronavirusIndividuals who show symptoms related to COVID-19 (fever, dry cough, tiredness, sore throat,headache etc)Employees to perform regular testing to avoid workplace transmission Other appropriate and necessary screenings (such as International Entrance, cross-state, pre-employment screening, pre-admission to higher learning institutions etc.
The FactView Vitamin D Rapid Test Device is a diagnostic assay used for the qualitative detection of Vitamin D levels in blood samples. Here's more information about this type of diagnostic test: Purpose: The test is used for the rapid detection of Vitamin D deficiency or insufficiency. Vitamin D is essential for bone health, immune function, and various other physiological processes in the body. Principle: The FactView Vitamin D Rapid Test Device is typically an immunochromatographic assay that detects the presence of Vitamin D in a patient's blood sample. The test device contains specific antibodies or receptors that bind to Vitamin D molecules, leading to the formation of visible test lines. Components: The test kit usually includes test cassettes, sample droppers, buffer solutions, and desiccants. The test cassettes contain pre-coated membranes with specific reagents for capturing Vitamin D molecules. Procedure: The test procedure involves collecting a small amount of blood from the patient (usually obtained via finger prick) and applying it to the sample well of the test cassette. Buffer solution is then added, allowing the blood sample to migrate along the test strip. Results are typically visible within a few minutes. Interpretation: The appearance of colored lines on the test strip indicates the presence or absence of Vitamin D in the blood sample. A visible line in the control region indicates that the test is valid. Additional lines in the test region(s) indicate positive results for Vitamin D. Sensitivity and Specificity: The FactView Vitamin D Rapid Test Device demonstrates sensitivity and specificity for detecting Vitamin D levels within a certain range. However, like all diagnostic tests, false-positive and false-negative results are possible and should be interpreted in conjunction with clinical findings. Utility: The rapid detection of Vitamin D levels provides valuable information for assessing Vitamin D status, identifying deficiency or insufficiency, and guiding patient management decisions. Vitamin D deficiency is associated with various health problems, including bone disorders, immune dysfunction, and increased risk of certain diseases. Limitations: While rapid diagnostic tests are useful for Vitamin D screening, they have limitations compared to more accurate laboratory methods such as liquid chromatography-mass spectrometry (LC-MS). Factors such as test sensitivity, specificity, and the influence of interfering substances can affect test performance. Overall, the FactView Vitamin D Rapid Test Device is a convenient tool for assessing Vitamin D levels, allowing for timely intervention and management of Vitamin D-related health conditions. However, results should be interpreted carefully in conjunction with clinical evaluation and other laboratory tests.
"FactView Malaria Rapid PF/PV" likely refers to a diagnostic test for the rapid detection of Plasmodium falciparum (PF) and Plasmodium vivax (PV), two species of malaria parasites. Here's more information about this type of diagnostic test: Purpose: The FactView Malaria Rapid PF/PV test is used for the rapid detection of malaria infection caused by the Plasmodium falciparum and Plasmodium vivax parasites. Malaria is a serious infectious disease transmitted by the bite of infected Anopheles mosquitoes. Principle: The test is based on immunochromatographic principles, where specific antibodies are used to detect the presence of malaria antigens in a patient's blood sample. The presence of the PfHRP2 antigen indicates P. falciparum infection, while the presence of the pLDH antigen indicates P. vivax infection. Components: The FactView Malaria Rapid PF/PV test typically includes test cassettes, sample droppers, buffer solutions, and desiccants. The test cassettes contain pre-coated membranes with specific antibodies for detecting malaria antigens. Procedure: The test procedure involves collecting a small amount of blood from the patient (usually obtained via finger prick) and applying it to the sample well of the test cassette. Buffer solution is then added, allowing the blood sample to migrate along the test strip. Results are typically visible within 15-20 minutes. Interpretation: The appearance of colored lines on the test strip indicates the presence or absence of malaria antigens. A visible line in the control region indicates that the test is valid. Additional lines in the test regions indicate positive results for P. falciparum and/or P. vivax antigens. Sensitivity and Specificity: The FactView Malaria Rapid PF/PV test demonstrates high sensitivity and specificity for detecting malaria infections caused by P. falciparum and P. vivax parasites. However, like all diagnostic tests, false-positive and false-negative results are possible and should be interpreted in conjunction with clinical findings. Utility: Rapid diagnostic tests like the FactView Malaria Rapid PF/PV provide a quick and convenient method for diagnosing malaria infections in resource-limited settings, where access to laboratory facilities and microscopy may be limited. Limitations: While rapid diagnostic tests are valuable tools for malaria diagnosis, they have limitations compared to more sensitive methods such as microscopy or molecular testing. Factors such as test storage conditions, operator technique, and the stage of infection can influence test performance.
Various formats are available, and OEM and ODM customization is accepted.
A variety of malaria tests are available, including the Malaria Pf/Pv Test Malaria Pf/Pan Test Malaria Pf Test and Malaria Pan Test
First Response Malaria Ag. P.f. / P.v. Card Tests intended to be performed by trained users (In either laboratory or point of care settings) as qualitative screening in vitro diagnostic test for detection of P. falciparum and P. vivax. Product specifications : Sensitivity - 100% Specificity -100% Rapid Result time within 20 - 30 Minutes. Detects P. falciparum and P. vivax. Storage at 1 40C. Specimen Type- Whole Blood
CTK biotech, OnSite Chikungunya IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya (CHIK) virus in human serum, plasma or whole blood. CE certified.
CTK Biotech's , The OnSite Toxo IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-Toxoplasma gondii (T. gondii) in human serum, plasma or whole blood.
WHO Approved, First Response Malaria Antigen P.falciparum (HRP2) Card Test is intended to be performed by trained users (In either laboratory or point of care settings) as qualitative screening in vitro diagnostic test for detection of P. falciparum specific HRP2 antigen. Sensitivity - 100% Specificity - 100% Rapid Result time within 20 - 30 Minutes. Detects Histidine Rich protein(HRP2) of Plasmodium P.falciparum Storage at 1 40C. Specimen Type- Whole Blood
CTK Biotech's, OnSite H. pylori Ab Combo Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM and IgA) against Helicobacter pylori (H. pylori) in human serum, plasma or whole blood.
CTK BioTech's ' Designed to specifically detect low levels of fecal occult blood, hHB 25 ng/mL, Higher accuracy, sensitivity and specificity than the Guaiac Test, No dietary restrictions, Clear, easy-to-interpret result, Individually sealed foil pouches containing: One cassette test device,, One desiccant, Stool collection devices, each containing 2 mL of extraction buffer (REF SB-R2011), Patient ID stickers, One package insert (instruction for use).
UNIQUE FEATURES: EASY TO PERFORM: Rapid, One Step procedure. Test Procedure & interpretation of results printed on individual Pouch HIGHER SENSITIVITY: Sensitivity of 20 mIU/mL of hCG hormone in Urine ensure the early detection of Pregnancy FAST & ACCURATE RESULTS: Results within 5 minutes, Positive results just in 30 seconds BIGGEST TEST WINDOW WIDTH: Test window width of 4mm ensure the clear background and better readability of the test results USER FRIENDLY: Requires no external measurement system. Can be stored at Room Temperature (2 - 30C).
CTK BioTech's, CE certified, Utilizes recombinant chimeric dengue virus licensed from the US CDC Detects all four dengue serotypes Duo test format minimizes processing time IgM detection indicates recent infection IgG detection indicates recent or previous infections Ag detection indicates a current infection Individually sealed foil pouches containing: One cassette device One desiccant 5 �µL Capillary tubes (for Dengue IgG/IgM test) Plastic droppers (for Dengue Ag test) Sample diluent (REF SB-R0062, 5 mL/bottle) One package insert (instruction for use)
CTK BioTech's, CE certified, Single test for identifying acute infection and protective immunity by detecting and differentiating IgG and IgM anti-HAV Indicates protective immunity by detecting HAV IgG titers â?¥70 mIU/mL High confidence as it is traceable to the 2nd WHO International Standard for HAV, and IgM is in agreement with market leading ELISA test: Sensitivity: 94.8%; Specificity: 96.7% Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation Small sample volume (5 �µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial patient care action can begin during the patientâ??s visit as test results are available in 15 minutes. Easily transported, and can be stored for 24 months at 2-30oC Individually sealed foil pouches containing: One cassette device One desiccant 5 µL capillary tubes Sample diluent (REF SB-R0092, 5 mL/bottle) Package insert (instruction for use)
CTK BioTech's, CE certified, Single test for identifying acute infection and protective immunity by detecting and differentiating IgG and IgM anti-HAV Indicates protective immunity by detecting HAV IgG titers 70 mIU/mL High confidence as it is traceable to the 2nd WHO International Standard for HAV, and IgM is in agreement with market leading ELISA test: Sensitivity: 94.8%; Specificity: 96.7% Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation Small sample volume (5 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial patient care action can begin during the patient's visit as test results are available in 15 minutes. Easily transported, and can be stored for 24 months at 2-30oC Individually sealed foil pouches containing: One cassette device One desiccant 5 µL capillary tubes Sample diluent (REF SB-R0092, 5 mL/bottle) Package insert (instruction for use).
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
Cat No: 41FK10. Panbio COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapidtest for the qualitative detection of SARS-CoV-2 antigen (Ag) in humannasopharyngeal swab specimens from individuals who meet COVID-19clinical and / or epidemiological criteria. Panbio COVID-19 Ag RapidTest Device is for professional use only and is intended to be used asan aid in the diagnosis of SARS-CoV-2 infection.
Cat No : COVAG025. GenBody COVID-19 Ag is an immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal and oropharyngeal swab from human.
Cat. No : 5513C. COVID-19 serology test.Cellex qSARS-CoV-2 IgG/IgM Rapid Test.qSARS-CoV-2 IgG/IgM Rapid Test Cassette.FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19
