Torch IgG/IgM Ab Panel Rapid Test

Tell Me Fast Torch Panel (IgG/IgM) Test is a rapid and convenient immunochromatographic in vitro assay for simultaneous and differential detection of Toxoplasma Gondi IgG/IgM, Cytomegalovirus IgG/IgM, HSV-1 IgG/IgM, HSV-2 IgG/IgM and Rubella Virus IgG/IgM antibodies in human serum/plasma or whole blood. This Test provides a visual, qualitative and preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the results of the test.

 

Herpes Simplex Virus (HSV) 2 IgG/IgM Ab Rapid Test

CE APPROVED

A rapid test for the detection IgG & IgM Antibodies of Herpes Simplex Virus (HSV) 2 Virus infection in serum, plasma and whole blood samples. For professional in vitro diagnostic use only.

Intended Use:

Tell Me Fast One Step HSV-II antibody test is a rapid and convenient immunochromatographic in vitro assay. It is used for determination of Herpes Simplex Virus (HSV) IgG and IgM antibodies in human serum, plasma or whole blood. This assay provides a visual, qualitative result. Clinical expertise and professional judgment should be sought to further evaluate the results of the test. This test is intended for professional use as an aid in the diagnosis of HSV and results should be confirmed with other qualified assays.

Summary and Principle:

Herpes Simplex Virus (HSV) is a common pathogen of humans. The clinical course of HSV in humans is extremely variable. Primary infection with HSV, either type 1 or 2, is unapparent or subclinical in a majority of cases. When clinically apparent, HSV infections can range from minimal stomatitis to a fatal generalized infection. Some of the major clinical manifestations of HSV infections are acute gingivostomatitis, recurrent herpes labialis, keratoconjunctivitis, eczema herpeticum, encephalitis, and meningitis. Generalized infections are normally confined to individuals with immune deficiency, immunosuppressed patients, or newborns. There are two distinct types of HSV: Types 1 and 2. HSV-1 and HSV-2 are closely related but they can be separated both serologically and biologically. HSV-1 is associated with lesions above the waist (encephalitis, stomatitis, eye infections, and, in some cases, of generalized infections). HSV-2 is primarily an infection of the genitalia and surrounding area. HSV-2 is sexually transmitted and is the cause of a large majority of generalized infections of the newborn. However, a strict relationship of localization and types of HSV is not absolute. Tell Me Fast One Step HSV-II IgG/IgM Antibody Test employs the use of an antibody binding protein conjugated to a colloidal gold particle and a unique combination of HSV antigens immobilized on the membrane. When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate to form antibody binding / gold complex. These complexes will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HSV antigens to form a visible red line. The un-bound gold conjugate will continue to move to the Control Zone (C) forming a visible red line. If there are no antibodies in sample, a red line is only appeared at the Control Zone (C). To serve as an internal process control, a control band should always be seen after test is completed. Absence of a colored control line in the control region is an indication of an invalid result. A definitive diagnosis should be given only when the clinical signs and symptoms of the patient are compatible.

 

A rapid test for the detection IgG & IgM Antibodies of Herpes Simplex Virus (HSV) 1 Virus infection in serum, plasma and whole blood samples. For professional in vitro diagnostic use only.

Intended Use:

Tell Me Fast One Step HSV-I antibody test is a rapid and convenient immunochromatographic in vitro assay. It is used for determination of Herpes Simplex Virus (HSV) IgG and IgM antibodies in human serum, plasma or whole blood. This assay provides a visual, qualitative result. Clinical expertise and professional judgement should be sought to further evaluate the results of the test. This test is intended for professional use as an aid in the diagnosis of HSV and results should be confirmed with other qualified assays.

Summary and Principle:

Herpes Simplex Virus (HSV) is a common pathogen of humans. The clinical course of HSV in humans is extremely variable. Primary infection with HSV, either type 1 or 2, is unapparent or subclinical in a majority of cases. When clinically apparent, HSV infections can range from minimal stomatitis to a fatal generalized infection. Some of the major clinical manifestations of HSV infections are acute gingivostomatitis, recurrent herpes labialis, keratoconjunctivitis, eczema herpeticum, encephalitis, and meningitis. Generalized infections are normally confined to individuals with immune deficiency, immunosuppressed patients, or newborns. There are two distinct types of HSV: Types 1 and 2. HSV-1 and HSV-2 are closely related but they can be separated both serologically and biologically. HSV-1 is associated with lesions above the waist (encephalitis, stomatitis, eye infections, and, in some cases, of generalized infections). HSV-2 is primarily an infection of the genitalia and surrounding area. HSV-2 is sexually transmitted and is the cause of a large majority of generalized infections of the newborn. However, a strict relationship of localization and types of HSV is not absolute. Tell Me Fast One Step HSV-I IgG/IgM Antibody Test employs the use of an antibody binding protein conjugated to a colloidal gold particle and a unique combination of HSV antigens immobilized on the membrane. When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate to form antibody binding / gold complex. These complexes will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HSV antigens to form a visible red line. The un-bound gold conjugate will continue to move to the Control Zone (C) forming a visible red line. If there are no antibodies in sample, a red line is only appeared at the Control Zone (C). To serve as an internal process control, a control band should always be seen after test is completed. Absence of a colored control line in the control region is an indication of an invalid result. A definitive diagnosis should be given only when the clinical signs and symptoms of the patient are compatible.

Herpes Simplex Virus (HSV) 1 IgG/IgM Ab Rapid Test

CE APPROVED

 

A rapid test for the detection IgG & IgM Antibodies of Rubella Virus infection in serum, plasma and whole blood samples.

For professional in vitro diagnostic use only.

Intended Use:

Tell Me Fast Rubella Virus (RV) IgG/IgM antibody test is a rapid and convenient immunochromatographic in vitro assay. It is used for determination of RV IgG and IgM antibodies in human serum, plasma or whole blood. This assay provides a visual, qualitative result. Clinical expertise and professional judgment should be sought to further evaluate the results of the test. This test is intended for professional use as an aid in the diagnosis of Rubella Virus Infection.

Summary and Principle:

Rubella virus is a member of the Togaviridae family, found mainly in human populations. Although rubella can strike people of all ages, it poses the greatest danger to unborn babies. Congenital rubella syndrome (CRS) occurs when the rubella virus attacks a developing fetus. Up to 85% of infants infected during the first trimester will be born with birth defects, including deafness, blindness, heart defects, and mental retardation. Miscarriages are also common. Growth retardation and diabetes mellitus have also been associated with late complications of congenital rubella. In an adult, IgG antibodies usually persist throughout life, while IgM appear after the rash fade but don't persisit after serveral weeks. So, the determination of rubella IgM antibody is particularly useful for the effective distinction between recent infection or vaccination, and acquired immunity. Screening for IgG antibodies to rubella virus is also a useful tool for diagnosis of the rubella disease and for determination of the immune status.   Tell Me Fast Rubella Virus IgG/IgM antibody test is based on the principle of Gold Immunochromatography Assay. Specific Rubella Virus recombinant antigens and anti-human monoclonal antibodies are used to detect RV IgM and IgG antibodies respectively in the human serum, plasma or whole blood samples with high sensitivity and specificity. First a specimen is dispensed with sample buffer, the Gold antigen conjugate will bind to anti-Rubella Virus IgG and IgM antibodies in the specimen sample which in turn will bind with Anti-Human IgG and Anti-Human IgM coated on the membrane as two separate lines in the test region as the reagent move across the membrane. The anti-Human antibodies on the membrane will bind the IgG or IgM antigen complex at the relevant IgG and or IgM test lines causing pale or dark pink lines to form at the IgG or IgM region of the test membrane. The intensity of the lines will vary depending upon the amount of antibody present in the sample. The appearance of pink line in a specific test region (IgG or IgM) should be considered as positive for that particular antibody type (IgG or IgM).The unbounded complex moves on to the control region (C), where they are captured by the anti-mouse antibody, and a red or pink line will appear, indicating the assay is a valid one. So the control line provides an internal quality control mechanism. A definitive diagnosis should be given only when the clinical signs and symptoms of the patient are compatible. A definitive diagnosis should be given only when the clinical signs and symptoms of the patient are compatible.

Rubella Virus IgG/IgM Ab Rapid Test

 

A rapid test for the detection IgG & IgM Antibodies of Cytomegalovirus infection in serum, plasma and whole blood samples.

For professional in vitro diagnostic use only.

Intended Use:

Tell Me Fast Cytomegalovirus (CMV) antibody test is a rapid and convenient immunochromatographic in vitro assay. It is used for determination of CMV IgG and IgM antibodies in human serum, plasma or whole blood. This assay provides a visual, qualitative result. Clinical expertise and professional judgment should be sought to further evaluate the results of the test. This test is intended for professional use as an aid in the diagnosis of Cytomegalovirus.

Summary and Principle:

CMV is a viral genus of the Herpesviruses group. In humans it is commonly known as HCMV or Human Herpesvirus 5 (HHV-5). HCMV infections are frequently associated with salivary glands, though they may be found throughout the body. The symptoms of a CMV infection vary depending upon the age and health of the person who is infected. Most of these infants show no symptoms of CMV infection, however, a few may develop pneumonia or other symptoms, including premature delivery, jaundice, enlarged liver and spleen, microcephaly seizures, rash, and feeding difficulties. Newborns can also contract CMV infection during birth or breast milk by the infected mother. Older children and teens who become infected with the virus may have mononucleosis-like symptoms, including fatigue, muscle aches, headache, fever and enlarged liver and spleen. These symptoms are generally mild, and usually last only 2-3 weeks. In people who have received organ transplants, or in people whose immune systems are weakened, CMV can cause serious infections. In people who have AIDS or HIV, CMV infection may involve the lungs, nervous system, gastrointestinal tract, and the eye, sometimes causing blindness. Transmission of CMV occurs from person to person through bodily fluids. CMV can be sexually transmitted and can also be transmitted via brease milk, transplanted organs, and rarely blood transfusions. Tell Me Fast One Step CMV IgM / IgG test is based on the principle of gold immunochromatography assay. Specific CMV recombinant antigens and anti-human monoclonal antibodies are used to detect CMV IgM and IgG antibodies respectively in the human serum, plasma or whole blood samples with high sensitivity and specificity. If there is CMV IgM/IgG antibody in the specimen, these antibodies will react with the anti-human monoclonal antibodies conjugated with gold to form complexes which move along the strip chromatographically to the test region (T), where these complexes will be captured by the pre-coated recombinant CMV antigens. Then a red or pink line will appear, indicating a positive result. The unbounded complex moves on to the control region (C), where they are captured by the anti-mouse antibody, and a red or pink line will appear, indicating the assay is a valid one. So the control line provides an internal quality control mechanism. The detecting of CMV IgM antibody enables effective diagnosis of acute or recent CMV infection. The test is particularly useful for the follow-up of pregnant women, who were not previously exposed to CMV and consequently are not protected against the virus. In addition, determination of specific IgM antibody in the newborn is useful for the diagnosis of congenital CMV infection. Screening for IgG antibodies to CMV is useful to detect previous exposure to CMV. By detecting the Cytomegalovirus specific antibodies in serum samples, and by differentiating the IgM and IgG antibodies, these two CMV antibody tests can help to determine the immune status and the infection status of the patient, thus Cytomegalovirus tests help disease administration properly. A definitive diagnosis should be given only when the clinical signs and symptoms of the patient are compatible.

Cytomagalovirus (CMV) IgG/IgM Ab Test

 

Toxoplasma gondi (Toxo) IgG/IgM Ab Rapid Test

A rapid test for the detection IgG & IgM Antibodies of Toxoplasma gondi  infection in serum, plasma and whole blood samples.

For professional in vitro diagnostic use only.

Intended Use:

Tell Me Fast Toxoplasma gondii (TOXO) antibody test is a rapid and convenient immunochromatographic in vitro assay. It is used for determination of TOXO IgG and IgM antibodies in human serum, plasma or whole blood. This assay provides a visual, qualitative result. Clinical expertise and professional judgment should be sought to further evaluate the results of the test. This test is intended for professional use as an aid in the diagnosis of Toxoplasmosis.

Summary and Principle:

Toxoplasma gondii is a species of parasitic protozoa in the genus Toxoplasma and can cause toxoplasmosis, a parasitic disease. The parasite infects most genera of warm-blooded animals, including humans, but the primary host is the felid family. Animals are infected by eating infected meat, by ingestion of feces of a cat that has itself recently been infected, or by transmission from mother to fetus. Cats have been shown as a major reservoir of this infection.  During the first few weeks, the infection typically causes a mild flu-like illness or no illness. After the first few weeks of infection have passed, the parasite rarely causes any symptoms in otherwise healthy adults. However, people with a weakened immune system, such as those infected with HIV or pregnant, may become seriously ill, and it can occasionally be fatal. The parasite can cause encephalitis and neurologic diseases and can affect the heart, liver and eyes (chorioretinitis).  Tell Me Fast One Step TOXO Antibody Test employs the use of an antibody binding protein conjugated to a colloidal gold particle and a unique combination of TOXO antigens immobilized on the membrane. When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate to form antibody binding / gold complex. These complexes will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the TOXO antigens to form a visible red line. The un-bound gold conjugate will continue to move to the Control Zone (C) forming a visible red line. If there are no antibodies in sample, a red line is only appeared at the Control Zone (C). To serve as an internal process control, a control band should always be seen after test is completed. Absence of a colored control line in the control region is an indication of an invalid result. A definitive diagnosis should be given only when the clinical signs and symptoms of the patient are compatible.

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