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CTK BIOTECH, INC.

CTK BIOTECH, INC.

CTK Biotech develops and manufactures immunodiagnostic tools and point of care diagnostic test kits for medical professionals to quickly and accurately diagnose disease and meet patient needs. The simplicity and portability of its test kits make them ideal for use in a wide range of settings, including remote location ...
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Covid-19 CTK BIOTECH, INC.

Clinical Laboratory

COVID-19 Ag Self Test
OnSite COVID-19 Ag Self Test

The OnSite COVID-19 Ag Self Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19. The test is designed for use with self-collected samples within the first 7 days post-onset of symptoms, as an aid in identifying SARS-CoV-2 infection.
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COVID-19 IgG/IgM Rapid Test External Control
Positivia COVID-19 IgG/IgM Rapid Test External Control Kit

The Positivia COVID-19 IgG/IgM Rapid Test External Control Kit is intended for use with the COVID-19 IgG/IgM Rapid Test (REF R0180C) to monitor the test performance.
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Immunoassay Analyzer
ALTA AutoLYZER

The ALTA AutoLYZER fully automatic immunoassay analyzer is controlled with intuitive proprietary software to perform all aspects of immunoassay analysis from protocol programming and execution, to data analysis and exportation. It consists of a pipette module, a wash module, an incubating module, a reading module, sample and reagent racks, and disposable tip racks.
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COVID-19 Antigen Rapid Test
OnSite COVID-19 Ag Rapid Test

The OnSite COVID-19 Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal (NP), or nasal swab specimens from individuals who are suspected of COVID-19, within the first seven days of the onset of symptoms. The test is easy to use, cost-efficient and can be done at the point of care, and is intended for use by healthcare providers or personnel trained in rapid test procedure.
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COVID-19 & Influenza A/B Ag Rapid Test
OnSite COVID-19 + Influenza A/B Ag Rapid Test

The OnSite COVID-19 + Influenza A/B Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens and the qualitative detection and differentiation of Influenza A (including H5N1 and H1N1) and Influenza B viral antigens in nasopharyngeal (NP) swab or nasal swab specimens. The test is intended for use by healthcare professional or personnel train in rapid test procedure.
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COVID-19 Antigen Rapid Test
OnSite COVID-19 Ab Rapid Test

The OnSite COVID-19 Ab Rapid Test is a single use lateral flow immunoassay rapid test intended for qualitative detection of anti-SARS-CoV-2 total antibodies in serum, plasma or whole blood containing EDTA, heparin or citrate anti-coagulants. It is presumed that the test may detect anti-SARS-CoV-2 antibodies in other species of mammals, including mink. The test is intended for research use only, not for use in diagnostic procedures.
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COVID-19 IgG/IgM Rapid Test
OnSite COVID-19 IgG/IgM Rapid Test

The OnSite COVID-19 IgG/IgM Rapid Test is designed for initial screening by detecting anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within just 10 minutes. It has 96.9% sensitivity and 99.4% specificity, making it one of the most effective screening tests for COVID-19, and is easy-to-use, requiring only minimally skilled personnel with basic equipment needs.
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COVID-19 Real-Time PCR Test
Aridia COVID-19 Real-Time PCR Test

The Aridia COVID-19 Real-Time PCR Test has 95.1% sensitivity, 95.9% specificity by utilizing multiplex PCR-fluorescent probe technology, combined with fast one-step RT-PCR technology. With the designed dual-target gene detection primer-probe, the test is designed to work with open PCR systems, making it a practical solution for all types of laboratories.
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About CTK BIOTECH, INC.

CTK Biotech develops and manufactures immunodiagnostic tools and point of care diagnostic test kits for medical professionals to quickly and accurately diagnose disease and meet patient needs. The simplicity and portability of its test kits make them ideal for use in a wide range of settings, including remote locations and countries with large populations where complicated medical diagnostics are not readily available.

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HAV Rapid Test
OnSite HAV IgG/IgM Rapid Test

The OnSite HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay that detects and differentiates antibodies to Hepatitis A virus (HAV) in human serum, plasma, or whole blood. This test provides high-confidence results for identifying acute infections and protective immunity against HAV, with a sensitivity of 94.8% and specificity of 96.7%. It offers rapid results in just 15 minutes, facilitating immediate patient care and decision-making in clinical environments without the need for specialized equipment.
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hCG Rapid Test
OnSite hCG Combo Rapid Test

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection.
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Malaria Pf/Pv Combo Rapid Test
OnSite Malaria Pf/Pv Ab Combo Rapid Test

The OnSite Malaria Pf/Pv Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) in human serum, plasma or whole blood. This test is easy to use and delivers quick results, making it an essential tool for malaria diagnosis in clinical settings. Its high sensitivity ensures accurate detection of malaria infections, providing timely insights for effective treatment and management of the disease.
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Clinical Laboratory

HAV Rapid Test
OnSite HAV IgG/IgM Rapid Test

The OnSite HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay that detects and differentiates antibodies to Hepatitis A virus (HAV) in human serum, plasma, or whole blood. This test provides high-confidence results for identifying acute infections and protective immunity against HAV, with a sensitivity of 94.8% and specificity of 96.7%. It offers rapid results in just 15 minutes, facilitating immediate patient care and decision-making in clinical environments without the need for specialized equipment.
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hCG Rapid Test
OnSite hCG Combo Rapid Test

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection.
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Malaria Pf/Pv Combo Rapid Test
OnSite Malaria Pf/Pv Ab Combo Rapid Test

The OnSite Malaria Pf/Pv Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) in human serum, plasma or whole blood. This test is easy to use and delivers quick results, making it an essential tool for malaria diagnosis in clinical settings. Its high sensitivity ensures accurate detection of malaria infections, providing timely insights for effective treatment and management of the disease.
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Dengue Rapid Test
OnSite Duo Dengue Ag-IgG/IgM Rapid Test

The OnSite Duo Dengue Ag-IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti-dengue virus, IgM anti-dengue virus and dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood. This antigen-antibody dual detection test is a noninvasive diagnostic method and can be performed in 20-25 minutes by minimally skilled personnel without using laboratory equipment.
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Typhoid Rapid Test
OnSite Typhoid IgG/IgM Combo Rapid Test

The OnSite Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood. This antibody detection test is a noninvasive diagnostic method and can be performed within 15 minutes by minimally skilled personnel without using laboratory equipment.
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Leptospira Rapid Test
OnSite Leptospira IgG/IgM Combo Rapid Test

The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay that can be performed within 15-20 minutes by minimally skilled personnel, and without the use of laboratory equipment. This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood.
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Dengue Rapid Test
OnSite Dengue IgG/IgM Combo Rapid Test

The OnSite Dengue IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti–dengue virus (DEN1, 2, 3 and 4) in human serum, plasma or whole blood. This antibody detection test is a noninvasive diagnostic method and can be performed in 15 minutes by minimally skilled personnel without using laboratory equipment.
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Syphilis Rapid Test
OnSite Syphilis Ab Combo Rapid Test

The OnSite Syphilis Ab Combo Rapid Test is a lateral flow immunoassay for qualitative detection of IgG, IgM, and IgA antibodies to Treponema pallidum in serum, plasma, or whole blood. With a simple test procedure and clear result interpretation, it allows accurate screening across all disease stages. The test does not require additional equipment and is externally validated for performance.
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Hepatitis B Test
OnSite HBsAg Rapid Test

The OnSite HBsAg Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma at a level equal to or higher than 1 ng/mL. It can be performed without the use of laboratory equipment and delivers results in 15 minutes.
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HIV/Syphilis Combo Test
OnSite HIV/Syphilis Ab Combo Rapid Test

The OnSite HIV/Syphilis Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to HIV-1, HIV-2 and Treponema pallidum (Tp) in human serum, plasma or whole blood. This antibody detection test is a noninvasive diagnostic method and can be performed within 15 minutes by minimally skilled personnel without using laboratory equipment.
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Hepatitis C Virus Test
HCV Ab Plus Rapid Test

The HCV Ab Plus Rapid Test is designed to detect antibodies to the hepatitis C virus (HCV). It uses a double antigen method for high sensitivity, providing fast, reliable results without the need for additional equipment. Suitable for serum or plasma, this test aids in HCV screening and diagnosis.
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Syphilis Rapid Test
OnSite Syphilis Ab Rapid Test

The OnSite Syphilis Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human serum or plasma. The test provides results within minutes and requires no special equipment, aiding in early syphilis diagnosis.
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Chikungunya Rapid Test
OnSite Chikungunya IgM Combo Rapid Test

The 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. The test can be used to distinguish CHIK infection from dengue infection which presents with similar symptoms.
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HIV Ag/Ab Rapid Test
OnSite HIV Ag/Ab 4th Gen. Rapid Test

The OnSite HIV Ag/Ab 4th Gen. Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies (IgG, IgM, IgA) to anti-HIV-1 (including O) and 2 viruses and HIV-1 p24 antigen in human serum, plasma or whole blood. The results are available within 15 minutes to allow prompt action to be taken at the point of care.
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Human Chorionic Gonadotropin Test
OnSite hCG Combo Rapid Test

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, Human Chorionic Gonadotropin (hCG) in human serum, plasma, and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment.
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HIV-1 & HIV-2 Rapid Test
OnSite HIV 1/2 Ab Plus Combo Rapid Test

The OnSite HIV 1/2 Ab Plus Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of HIV-1 and HIV-2 antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. The results are available within 15 minutes to allow prompt action to be taken at the point of care.
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Malaria Rapid Test
OnSite Malaria Pf/Pan Ag Rapid Test

The OnSite Malaria Pf/Pan Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax (Pv), P. ovale (Po), or P. malariae (Pm) antigen in human blood specimen. It offers ease of use, requires minimal training of personnel, and expanded testing facility options including areas where quality microscopy is not available.
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Leishmania Rapid Test
OnSite Leishmania Ab Rapid Test

The OnSite Leishmania Ab Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans, in human serum or plasma. Using a simple test procedure, it detects both IgG and IgM to L. donovani without the need for equipment.
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Hepatitis B Rapid Test
OnSite HBsAg/HCV Ab Rapid Test

The OnSite HBsAg/HCV Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. Using serum, plasma, or whole blood, the three-line test offers results in 15 minutes without the need for equipment.
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Hepatitis C Rapid Test
OnSite HCV Ab Plus Combo Rapid Test

The OnSite HCV Ab Plus Combo Rapid Test is a double antigen lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis C virus antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. Using a simple test procedure, it offers efficient, easy-to-interpret results without the need for equipment.
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Chagas Rapid Test
OnSite Chagas Ab Combo Rapid Test

The OnSite Chagas Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum, plasma or whole blood. The test has a simple procedure and does not require any equipment, making it suitable for use at the point of care.
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Cytomegalovirus Rapid Test
OnSite CMV IgG/IgM Rapid Test

The OnSite CMV IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgM and IgG antibodies to cytomegalovirus (CMV) in human serum, plasma, or whole blood. The individually sealed foil pouches contain one cassette device, one desiccant, 10 µL capillary tubes, a sample diluent (REF SB-R0224, 5 mL/bottle), and one package insert (instructions for use).
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HIV Rapid Test Control
Positivia HIV-1 P24 Rapid Test Control Kit

The Positivia HIV-1 P24 Rapid Test Control Kit is intended for use with the OnSite HIV Ag/Ab 4th Gen. Rapid Test as external assay controls to monitor test performance.
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HIV/Syphilis/HBV/HCV Rapid Test
OnSite HIV/Syphilis/HBV/HCV Panel Rapid Test

The OnSite HIV/Syphilis/HBV/HCV Panel Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of hepatitis B surface antigen (HBsAg) and antibodies to HIV-1, HIV-2, Treponema pallidum (Tp), and HCV in human serum, plasma, or whole blood. This antigen-antibody panel rapid test is a non-invasive diagnostic method and can be performed in 15 minutes by minimally skilled personnel without using laboratory equipment.
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H. pylori Test
OnSite H. pylori Ag Rapid Test

The OnSite H. pylori Ag Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of H. pylori antigen in human fecal specimens. This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with H. pylori. This noninvasive diagnostic method can be performed within 10 minutes by minimally skilled personnel without the use of laboratory equipment.
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Prostate Specific Antigen Test
OnSite PSA Semi-quantitative Rapid Test

The OnSite PSA Semi-quantitative Rapid Test is a lateral flow chromatographic immunoassay for the semi-quantitative detection of Prostate Specific Antigen (PSA) in human whole blood, serum, or plasma at a cut-off level of 4 ng/mL. The test’s three-line result facilitates the determination of a patient’s PSA level.
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Herpes Simplex Virus Test
OnSite HSV-1 IgG/IgM Rapid Test

The OnSite HSV-1 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to Herpes Simplex Virus 1 (HSV-1). Flexible specimen types including serum, plasma, or whole blood allow testing at any time without special specimen preparation.
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Syphilis Rapid Test
OnSite Syphilis Ab Rapid Test

The OnSite Syphilis Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human serum or plasma. It has a simple test procedure and offers efficient, easy-to-interpret results without the need for any additional equipment.
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Respiratory Syncytial Virus (RSV) Test
OnSite RSV Ag Rapid Test

The OnSite RSV Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigens in nasopharyngeal swabs or nasal aspirate specimens. It features an ergonomic, user-friendly extraction tube that minimizes contamination and positive results are visible in as soon as 3 minutes.
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Typhoid Combo Rapid Test
OnSite Typhoid IgG/IgM Combo Rapid Test

The OnSite Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood. It has a one-step procedure to minimize operator error due to sample preparation and provides test results within 15 minutes, allowing medical professionals to take immediate action.
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Typhoid Test
OnSite S. Typhi/Paratyphi Ag Rapid Test

The OnSite S. Typhi/Paratyphi Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Salmonella typhi (S. typhi) and Salmonella paratyphi (S. paratyphi) antigens in a human fecal specimen and blood culture specimen. It has a simple procedure that minimizes operator error due to sample preparation and provides test results within 15 minutes, allowing medical professionals to take immediate action.
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cTnI Test
OnSite Troponin I Combo Rapid Test

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma, or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment.
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Rubella Virus Antibody Test
OnSite Rubella IgG/IgM Rapid Test

The OnSite Rubella IgG/IgM Rapid Test is a lateral flow immunoassay for the semi-quantitative detection and differentiation of antibodies (IgG and IgM) to rubella virus in human serum, plasma, or whole blood. Designed for obstetric and symptomatic patient screening, it is the first rapid test to discriminate between patients at risk for, protected from, or currently experiencing rubella infection.
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Rapid FOB Test
OnSite FOB-Hi Rapid Test

The OnSite FOB-Hi Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of fecal occult blood in human fecal specimens in laboratories or physician offices. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the detection of bleeding caused by a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.
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TORCH Infections Test
OnSite TORCH Panel Rapid Test

The OnSite TORCH Panel Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to Toxoplasma gondii (T. gondii), rubella virus, cytomegalovirus (CMV), herpes simplex virus 1 (HSV-1), and herpes simplex virus 2 (HSV-2) in human serum, plasma, or whole blood. The test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with T. gondii, rubella virus, CMV, HSV-1 and HSV-2.
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HSV-2 IgG/IgM Test
OnSite HSV-2 IgG/IgM Rapid Test

The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. The test utilizes glycoprotein G2 to differentiate between HSV-1 and HSV-2, allowing for immediate determination of either acute or chronic infection and early start of treatment action.
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T. gondii IgG/IgM Test
OnSite Toxo IgG/IgM Combo Rapid Test

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.
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Myoglobin Fluorescence ImmunoAssay Test
MYO FIA Test

The Myoglobin (MYO) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of MYO in human serum or plasma, with a cut-off level of 55.0 ng/mL, using the RaFIA system. The test is intended for in vitro diagnostic use only and was developed to detect the concentration of MYO within 15 minutes without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.
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Ferritin (FTN) Test
Ferritin ELISA CE

The Ferritin ELISA is a solid-phase enzyme-linked immunosorbent assay that is intended for the quantitative determination of ferritin (FTN) concentration in human serum. It is intended to be used by professionals as an aid in the measurement of iron status in patients with iron-related conditions such as anemia, hemochromatosis, porphyria, chronic inflammatory disorder, liver disease, hyperthyroidism, Leukemia, Hodgkin’s lymphoma, or alcohol abuse.
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D-Dimer Fluorescence ImmunoAssay Test
D-Dimer FIA Test

The D-Dimer Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of D-Dimer in human plasma or whole blood using the RaFIA system. This test is intended for in vitro diagnostic use only and was developed to detect D-Dimer within three minutes without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.
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Alpha-Fetoprotein Test
AFP FIA Test

The AFP FIA Test is a fluorescence immunoassay test for measuring alpha-fetoprotein (AFP) levels in pregnant women and can help indicate if there is a development issue with the fetus’ neural tube that later becomes the brain and spinal cord. AFP is also associated with primary liver, stomach, lung, and other tumors, highlighting its value as a cancer marker. The test offers quantitative, non-subjective results, and increased sensitivity and broader detection range compared to rapid tests.
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Hepatitis B Rapid Test
OnSite HBV-5 Rapid Test

The OnSite HBV-5 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e-antigen (HBeAg), hepatitis B e-antibody (HBeAb), and hepatitis B core antibody (HBcAb) in human serum or plasma. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with hepatitis B virus (HBV).
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Influenza A/B Rapid Test
OnSite Influenza A/B Rapid Test with Positivia External Control

The OnSite Influenza A/B Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of Influenza A virus, including H5N1 and H1N1, and Influenza B virus in nasal/throat/nasopharyngeal swab or nasopharyngeal aspirate/wash specimens. The kit combines CTK’s Influenza A/B Rapid Test (strip) and CTK’s Positivia Influenza A/B Rapid Test Control Kit and is intended for use with the Influenza A/B Rapid Test as external assay controls to monitor test performance.
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HSV-1/2 IgG/IgM Rapid Test
OnSite Duo HSV-1/2 IgG/IgM Rapid Test

The OnSite Duo HSV-1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. The test can be performed in 10 minutes by minimally skilled personnel without the use of laboratory equipment and provides a preliminary test result to aid in the diagnosis of infection with HSV-1 and/or HSV-2.
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Follicle Stimulating Hormone Test
FSH ELISA

The CTK FSH ELISA is a solid-phase enzyme-linked immunosorbent assay intended for the quantitative determination of follicle stimulating hormone (FSH) level in human serum. Immunoassay measurement of FSH in human serum is a first-line approach in assessing FSH levels, providing important information for diagnostic and monitoring purposes in pregnancy, precocious puberty, menopause, castration, throughout hormone therapy, and in a variety of other medical conditions.
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Zika Virus ELISA Test
RecombiLISA Zika IgM ELISA CE

The RecombiLISA Zika IgM ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the indirect immunoassay technique and contains a 96-well breakable microplate pre-coated with Zika NS1 antigen and a liquid conjugate solution composed of horseradish peroxidase (HRP-anti-human IgM conjugates). The test is intended for the qualitative detection of IgM anti-Zika virus in human serum or plasma. It is intended to be used by professionals as an aid in the diagnosis of an acute infection with Zika virus.
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H. pylori Rapid Test
OnSite H. pylori Ab Combo Rapid Test CE

The 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. Featuring a non-invasive, easy to perform procedure, it has a time to result of 15 minutes and eliminates the need for avoiding certain medications.
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Creatine Kinase-MB FIA Test
CK-MB FIA Test

The Creatine Kinase-MB (CK-MB) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of CK-MB in human serum or plasma, with a cut-off level of 5.0 ng/mL, using the RaFIA system. As a heart-specific isoenzyme, CK-MB can be used to assist in the diagnosis of an acute myocardial infarction. The test is intended for in vitro diagnostic use only.
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Hepatitis B ELISA Test
RecombiLISA HBeAg ELISA

The RecombiLISA HBeAg ELISA is a solid phase enzyme-linked immunosorbent assay for the qualitative detection for professional use only as an aid in the diagnosis of infection with HBV. The test is intended for the qualitative detection of hepatitis B surface antigen (HBsAg) at a sensitivity level of 0.10 IU/mL in human serum or plasma.
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Hepatitis B Rapid Test
OnSite HBV-5 Rapid Test

The OnSite HBV-5 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e-antigen (HBeAg), hepatitis B e-antibody (HBeAb), and hepatitis B core antibody (HBcAb) in human serum or plasma. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with hepatitis B virus (HBV).
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Adenovirus Rapid Test
OnSite Adenovirus Ag Rapid Test

The OnSite Adenovirus Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of Adenovirus antigen in nasopharyngeal swab or nasal aspirate specimens. It comes with an ergonomic, user-friendly extraction tube that minimizes contamination and is CE mark approved for sale in Europe.
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Immunofluorescence Incubator
RaFIA Immunofluorescence Incubator

The RaFIA immunofluorescence incubator is an auxiliary device for the RaFIA immunofluorescence analyzer. Since reaction temperature and time is critical for specific test results, the incubator provides an optimized environment as well as automatic timers for test reactions to ensure the reliability of test results.
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COVID-19 Ag Self Test
OnSite COVID-19 Ag Self Test

The OnSite COVID-19 Ag Self Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19. The test is designed for use with self-collected samples within the first 7 days post-onset of symptoms, as an aid in identifying SARS-CoV-2 infection.
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Immunofluorescence Analyzer
RaFIA Immunofluorescence Analyzer

The RaFIA Immunofluorescence Analyzer is a fluorescence immunoassay analyzing instrument intended for use by healthcare professionals to aid in the diagnosis of conditions such as cardiovascular disease, pregnancy, infection, diabetes, renal injury and cancer. The in vitro diagnostic instrument can only accept test devices that are designed especially for this equipment, and provides reliable and quantitative results for a variety of analytes in human blood and urine within 20 minutes.
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Chemiluminescent Analyzer
ALTA CLIAlyzer

The ALTA CLIAlyzer is an intuitive bench-top chemiluminescent analyzer used for the quantitative determination of concentrations of various analytes found in serum, whole blood, or plasma specimens. The in vitro diagnostic device delivers results when paired with the company’s RapidLight tests, allowing for quick operation and use. Laboratories can run multiple specimen options and six tests simultaneously, providing up to 24 test results per hour.
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Immunoassay Analyzer
ALTA AutoLYZER

The ALTA AutoLYZER fully automatic immunoassay analyzer is controlled with intuitive proprietary software to perform all aspects of immunoassay analysis from protocol programming and execution, to data analysis and exportation. It consists of a pipette module, a wash module, an incubating module, a reading module, sample and reagent racks, and disposable tip racks.
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COVID-19 IgG/IgM Rapid Test External Control
Positivia COVID-19 IgG/IgM Rapid Test External Control Kit

The Positivia COVID-19 IgG/IgM Rapid Test External Control Kit is intended for use with the COVID-19 IgG/IgM Rapid Test (REF R0180C) to monitor the test performance.
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COVID-19 Antigen Rapid Test
OnSite COVID-19 Ab Rapid Test

The OnSite COVID-19 Ab Rapid Test is a single use lateral flow immunoassay rapid test intended for qualitative detection of anti-SARS-CoV-2 total antibodies in serum, plasma or whole blood containing EDTA, heparin or citrate anti-coagulants. It is presumed that the test may detect anti-SARS-CoV-2 antibodies in other species of mammals, including mink. The test is intended for research use only, not for use in diagnostic procedures.
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COVID-19 & Influenza A/B Ag Rapid Test
OnSite COVID-19 + Influenza A/B Ag Rapid Test

The OnSite COVID-19 + Influenza A/B Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens and the qualitative detection and differentiation of Influenza A (including H5N1 and H1N1) and Influenza B viral antigens in nasopharyngeal (NP) swab or nasal swab specimens. The test is intended for use by healthcare professional or personnel train in rapid test procedure.
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COVID-19 Antigen Rapid Test
OnSite COVID-19 Ag Rapid Test

The OnSite COVID-19 Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal (NP), or nasal swab specimens from individuals who are suspected of COVID-19, within the first seven days of the onset of symptoms. The test is easy to use, cost-efficient and can be done at the point of care, and is intended for use by healthcare providers or personnel trained in rapid test procedure.
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COVID-19 Real-Time PCR Test
Aridia COVID-19 Real-Time PCR Test

The Aridia COVID-19 Real-Time PCR Test has 95.1% sensitivity, 95.9% specificity by utilizing multiplex PCR-fluorescent probe technology, combined with fast one-step RT-PCR technology. With the designed dual-target gene detection primer-probe, the test is designed to work with open PCR systems, making it a practical solution for all types of laboratories.
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COVID-19 IgG/IgM Rapid Test
OnSite COVID-19 IgG/IgM Rapid Test

The OnSite COVID-19 IgG/IgM Rapid Test is designed for initial screening by detecting anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within just 10 minutes. It has 96.9% sensitivity and 99.4% specificity, making it one of the most effective screening tests for COVID-19, and is easy-to-use, requiring only minimally skilled personnel with basic equipment needs.
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Rapid Test
OnSite Chlamydia Rapid Test

The OnSite Chlamydia Rapid Test is a lateral flow immunoassay for the qualitative detection of Chlamydia trachomatis (C. trachomatis) antigen in endocervical or encourethral swab specimens. It comes in individually sealed foil pouches containing one cassette device and one desiccant, one vial of extraction buffer A (6 mL/vial), one vial of extraction buffer B (6 mL/vial) and 25 sample extraction tubes.
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Rapid Test
OnSite H. pylori Ab Combo Rapid Test

The 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. The non-invasive test has an easy to perform procedure with a time to result of 15 minutes and eliminates the need to avoid certain medications.
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Rapid Test Reader
RTR-1

The RTR-1 rapid test reader is specifically designed to measure and interpret lateral flow immunoassay test results. It provides test results through a visual readout on its screen and stores 1,000 results, which can be printed from memory or exported with a USB drive or computer.
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Zika/Dengue/Chikungunya PCR Test
Aridia Zika/Dengue/CHIK Real-Time PCR Test

The Aridia Zika/Dengue/CHIK Real-Time PCR Test is based on the real time amplification and detection of Zika virus (ZIKV), dengue virus (DENV), and/or chikungunya virus (CHIKV) RNA in a one-step format. Designed for specific and qualitative detection of ZIKV, DENV, and/or CHIKV RNA in clinical specimens, it aids the diagnosis of acute ZIKV, DENV, and/or CHIKV infection alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes.
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Dengue Rapid Test
OnSite Dengue Ag rapid Test

The OnSite Dengue Ag rapid Test CE is a lateral flow chromatographic immunoassay for the qualitative detection of dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood. The test is designed to be used by professionals as a screening test and provides a preliminary test result to aid the diagnosis of infection with dengue virus.
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Rapid Test Reader
ALTA Rapid Test Reader

The ALTA rapid test reader uses an image processing method for identification of either presence or absence of test line bands or test line band intensity levels. Based on the pre-configured intensity levels, the reader classifies the band intensity and reads out the results as either positive or negative.
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ELISA Reader
Alta ELISA Reader

The Alta ELISA Reader is a microplate analyzer for in vitro diagnostic use to measure and interpret ELISA test results, both monochromatically and bichromatically, with special filters for up to six standard wavelengths and integrated analysis software. It is intended for use for intensity measurements on a large as well as very small volume of samples in laboratories, pathology departments, blood banks and hospitals.
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HBsAg Test
HBsAg Combo Rapid Test

The OnSite HBsAg Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg). It delivers results in 15 minutes using serum, plasma or whole blood and can be performed without the use of laboratory equipment.
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ELISA Washer
Alta ELISA Washer

The Alta ELISA Washer is an easy-to-use, reliable washer for all microplate ELISA applications featuring built-in two plate ELISA incubators with the ability to wash single strip of eight wells. It features state of the art versatile software for user programmable soak time, wash cycles and dispensing volume, making it ideal for use in laboratories, pathology departments, and hospitals for washing ELISA microplates.
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Point-Of-Care Testing

Typhoid Rapid Test
OnSite Typhoid IgG/IgM Combo Rapid Test

The OnSite Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood. This antibody detection test is a noninvasive diagnostic method and can be performed within 15 minutes by minimally skilled personnel without using laboratory equipment.
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Leptospira Rapid Test
OnSite Leptospira IgG/IgM Combo Rapid Test

The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay that can be performed within 15-20 minutes by minimally skilled personnel, and without the use of laboratory equipment. This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood.
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Dengue Rapid Test
OnSite Dengue IgG/IgM Combo Rapid Test

The OnSite Dengue IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti–dengue virus (DEN1, 2, 3 and 4) in human serum, plasma or whole blood. This antibody detection test is a noninvasive diagnostic method and can be performed in 15 minutes by minimally skilled personnel without using laboratory equipment.
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Syphilis Rapid Test
OnSite Syphilis Ab Combo Rapid Test

The OnSite Syphilis Ab Combo Rapid Test is a lateral flow immunoassay for qualitative detection of IgG, IgM, and IgA antibodies to Treponema pallidum in serum, plasma, or whole blood. With a simple test procedure and clear result interpretation, it allows accurate screening across all disease stages. The test does not require additional equipment and is externally validated for performance.
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Hepatitis B Test
OnSite HBsAg Rapid Test

The OnSite HBsAg Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma at a level equal to or higher than 1 ng/mL. It can be performed without the use of laboratory equipment and delivers results in 15 minutes.
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HIV/Syphilis Combo Test
OnSite HIV/Syphilis Ab Combo Rapid Test

The OnSite HIV/Syphilis Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to HIV-1, HIV-2 and Treponema pallidum (Tp) in human serum, plasma or whole blood. This antibody detection test is a noninvasive diagnostic method and can be performed within 15 minutes by minimally skilled personnel without using laboratory equipment.
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Hepatitis C Virus Test
HCV Ab Plus Rapid Test

The HCV Ab Plus Rapid Test is designed to detect antibodies to the hepatitis C virus (HCV). It uses a double antigen method for high sensitivity, providing fast, reliable results without the need for additional equipment. Suitable for serum or plasma, this test aids in HCV screening and diagnosis.
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Syphilis Rapid Test
OnSite Syphilis Ab Rapid Test

The OnSite Syphilis Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human serum or plasma. The test provides results within minutes and requires no special equipment, aiding in early syphilis diagnosis.
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Chikungunya Rapid Test
OnSite Chikungunya IgM Combo Rapid Test

The 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. The test can be used to distinguish CHIK infection from dengue infection which presents with similar symptoms.
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HIV Ag/Ab Rapid Test
OnSite HIV Ag/Ab 4th Gen. Rapid Test

The OnSite HIV Ag/Ab 4th Gen. Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies (IgG, IgM, IgA) to anti-HIV-1 (including O) and 2 viruses and HIV-1 p24 antigen in human serum, plasma or whole blood. The results are available within 15 minutes to allow prompt action to be taken at the point of care.
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Human Chorionic Gonadotropin Test
OnSite hCG Combo Rapid Test

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, Human Chorionic Gonadotropin (hCG) in human serum, plasma, and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment.
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HIV-1 & HIV-2 Rapid Test
OnSite HIV 1/2 Ab Plus Combo Rapid Test

The OnSite HIV 1/2 Ab Plus Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of HIV-1 and HIV-2 antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. The results are available within 15 minutes to allow prompt action to be taken at the point of care.
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Chagas Rapid Test
OnSite Chagas Ab Combo Rapid Test

The OnSite Chagas Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum, plasma or whole blood. The test has a simple procedure and does not require any equipment, making it suitable for use at the point of care.
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Myoglobin Fluorescence ImmunoAssay Test
MYO FIA Test

The Myoglobin (MYO) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of MYO in human serum or plasma, with a cut-off level of 55.0 ng/mL, using the RaFIA system. The test is intended for in vitro diagnostic use only and was developed to detect the concentration of MYO within 15 minutes without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.
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D-Dimer Fluorescence ImmunoAssay Test
D-Dimer FIA Test

The D-Dimer Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of D-Dimer in human plasma or whole blood using the RaFIA system. This test is intended for in vitro diagnostic use only and was developed to detect D-Dimer within three minutes without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.
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