Respiratory Syncytial Virus (RSV) Test

 

Strep B Antigen Test

 

Strep A Antigen Test

 

Influenza A&B Antigen Test

 

HIV 1/2 Ab & P24 Ag Rapid Test (HIV 4th Generation)

 

Intended Use:

Biocan Tell Me Fast Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) antibody test and HIV 1 P24 antigen test is a rapid and convenient visually read qualitative immunochromatographic in vitro assay. It is used for detection of antibodies (IgG, IgM, IgA) to HIV-1 (including O) and HIV-2 antibodies and HIV 1 P24 Antigen in human serum, plasma or whole blood. The test is intended for healthcare professionals; point of care and near patient settings, field studies and mobile testing as an aid to detect HIV-1/HIV-2 antibodies and HIV 1 P24 antigen from infected individual. This is a preliminary screening test and results must be confirmed with other qualified assays.

Summary and Principle:

The Human Immunodeficiency Virus (HIV) is a lentivirus that causes Acquired Immunodeficiency Syndrome (AIDS). HIV attacks the immune system, resulting in a chronic, progressive illness and leading to life-threatening opportunistic infections. There are two types of HIV: HIV-1 and HIV-2. Both types are transmitted by transfusion of contaminated blood, sharing of contaminated needles and between a mother and her infant during pregnancy, childbirth and breastfeeding. Treatment with anti-retrovirals increases the life expectancy of people infected with HIV. Human immunodeficiency virus type I and type II (HIV-1 and HIV-2) are enveloped, single- stranded, positive-sense RNA viruses. The causative relationship between HIV-1 and HIV-2 viruses and acquired immunodeficiency syndrome (AIDS) has been established over decades. HIV-1 has been isolated from patients with AIDS and AIDS-related complex and from   healthy individuals with a high risk for developing AIDS. HIV-2 has been isolated from West African AIDS patients and from sero-positive asymptomatic individuals. HIV-1 is much more prevalent than HIV-2 worldwide. Recent studies have shown that over 30 million people have been infected with HIV-1. Both HIV-1 and HIV-2 viruses can elicit strong immune responses including the production of antiviral antibodies. Presence of specific anti-HIV-1 or HIV-2 virus antibodies in whole blood, serum or plasma indicates the exposure of an individual to the HIV-1 or HIV-2 which is of great value for clinical diagnosis. Tests that detect HIV p24  antigen may be  useful    for  the  early diagnosis of HIV as p24 antigen is one of the earliest markers of HIV infection. It has been suggested that HIV infection is detectable with a p24 antigen test 6 days earlier than an antibody test. The Biocan Tell Me Fast HIV Ag/Ab 4th Gen. Rapid Test utilizes recombinant gp-120-41, gp36 and anti-p24 antibodies can qualitatively detect antibodies (IgG, IgM, IgA) to anti-HIV-1 (including O) or HIV- 2 viruses and HIV-1 p24 antigen in patient serum, plasma or whole blood within 15 minutes. The test can be performed without any special laboratory equipment.

HIV 1/2 (Tri-Line) Antibody Rapid Test

 

(Serum/Plasma/Whole Blood)

Intended Use:

Biocan Tell Me Fast One Step Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) antibody test is a rapid and convenient visually read qualitative immunochromatographic in vitro assay. It is used for detection of antibodies to HIV-1/2 in human serum,  plasma or whole blood. The test is intended for healthcare professionals; point of care and near patient settings, field studies and mobile testing as an aid to detect HIV-1/HIV-2 antibodies from infected individual.

Summary and Principle:

The Human Immunodeficiency Virus (HIV) is a lentivirus that causes Acquired Immunodeficiency Syndrome (AIDS). HIV attacks the immune system, resulting in a chronic, progressive illness and leading to life-threatening opportunistic infections. There are two types of HIV: HIV-1 and HIV-2. Both types are transmitted by transfusion of contaminated blood, sharing of contaminated needles and between a mother and her infant during pregnancy, childbirth and breastfeeding. Treatment with anti-retrovirals increases the life expectancy of people infected with HIV. Tell Me Fast Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) Antibody test employs immunochromatographic test device. Proprietary Colloidal gold conjugated recombinant antigens are dry-immobilized at the end of nitrocellulose membrane strip. HIV-1 (GP 41) and HIV-2 (GP 36) antigen are bond at the Test Zone (T) and rabbit anti-HIV 1/2 monoclonal antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HIV 1/2 antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HIV 1/2 antigens generating a visible pink line. If there is no HIV 1 or 2 antibodies in sample, no pink line is formed in the Test Zone (T). The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the rabbit anti-HIV 1/2 antibodies aggregating in a pink line, which indicates the validity of the test.

HIV 1/2 (Tri-Line) Antibody Rapid Test

 

(Serum/Plasma)

Intended Use:

Biocan Tell Me Fast One Step Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) antibody test is a rapid and convenient visually read qualitative immunochromatographic in vitro assay. It is used for detection of antibodies to HIV-1/2 in human serum or plasma. The test is intended for healthcare professionals; point of care and near patient settings, field studies and mobile testing as an aid to detect HIV-1/HIV-2 antibodies from infected individual. This is a preliminary screening test and results must be confirmed with other qualified assays.

Summary and Principle:

The Human Immunodeficiency Virus (HIV) is a lentivirus that causes Acquired Immunodeficiency Syndrome (AIDS). HIV attacks the immune system, resulting in a chronic, progressive illness and leading to life-threatening opportunistic infections. There are two types of HIV: HIV-1 and HIV-2. Both types are transmitted by transfusion of contaminated blood, sharing of contaminated needles and between a mother and her infant during pregnancy, childbirth and breastfeeding. Treatment with anti-retrovirals increases the life expectancy of people infected with HIV. Tell Me Fast One Step Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) Antibody test employs proprietary Colloidal gold conjugated recombinant antigens are dry-immobilized at the end of nitrocellulose membrane strip. HIV-1 (GP 41, P24) and HIV-2 (GP 36) antigen are bond at the Test Zones (T1 HIV1 & T2 HIV2) and rabbit anti-HIV 1/2 monoclonal antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HIV 1/2 antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T1, T2) zone where they are captured by the HIV 1/2 antigens generating a visible pink line. If there is no HIV 1 or 2 antibodies in sample, no pink line is formed in the Test Zone (T1, T2). The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the rabbit anti-HIV 1/2 antibodies aggregating in a pink line, which indicates the validity of the test.

HIV/HCV/HBsAg Combo Triplex Rapid Test

 

Hepatitis C Virus (HCV) Antibody Rapid Test

 

(Serum/Plasma/Whole Blood)  

Intended Use:

Biocan Tell Me Fast One Step Hepatitis C (HCV) Antibody Test is a rapid and convenient immunochromatographic in vitro assay for detection of antibodies to Hepatitis C virus in human serum, plasma or whole blood. The test provides a visual, qualitative result, and all positive specimens must be confirmed with other qualified assays. The test is intended for healthcare professional use only.

Summary and Principle:

Hepatitis C virus (HCV) is now a main cause of hepatitis. The worldwide prevalence of HCV is 0.2 to 2 % on blood donors and up to 80% in intravenous drug users. Transmission of HCV is by transfusion and other parenteral means such as sharing of needles, occupational exposure to blood and haemodialysis. Chronic infection can lead to cirrhoses and hepatocellular carcinoma. However, chronic infection is often asymptomatic even in the presence of liver damage discernible on biopsy. The principle of rapid HCV antibody test is chromatographic immunoassay containing membrane coated with purified recombinant HCV proteins were employed to specifically identify anti-HCV with extremely high sensitivity. The test employs recombinant antigens (E.coli) analogous to structural (HCV-core-Ag) and non-structural (HCV-NS3-Ag, HCV-NS4-Ag & HCV-NS5-Ag) proteins of viral hepatitis C. Colloidal gold conjugated goat anti-human IgM and mouse anti-human IgG are dried and immobilized on the fiberglass strip. HCV antigens are immobilized at the Test Zone (T) and goat anti mouse IgG antibodies are immobilized at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HCV antibodies will bind the gold conjugated anti-human IgG and/or IgM forming complexes. These complexes will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HCV antigens to form a visible red line. The un-bound gold conjugate will continue to move and bind with goat anti-mouse IgG at the Control Zone (C) forming a visible red line. If no HCV antibodies in sample, a red line is only appeared at the Control Zone (C), which indicates the validity of the test.

Hepatitis C Virus (HCV) Antibody Rapid Test

 

(Serum/Plasma)  

Intended Use:

Biocan Tell Me Fast One Step Hepatitis C (HCV) Antibody Test is a rapid and convenient immunochromatographic in vitro assay for detection of antibodies to Hepatitis C virus in human serum or plasma. The test provides a visual, qualitative result, and all positive specimens must be confirmed with other qualified assays. The test is intended for healthcare professional use only.  

Summary and Principle:

Hepatitis C virus (HCV) is now a main cause of hepatitis. The worldwide prevalence of HCV is 0.2 to 2 % on blood donors and up to 80% in intravenous drug users. Transmission of HCV is by transfusion and other parenteral means such as sharing of needles, occupational exposure to blood and haemodialysis. Chronic infection can lead to cirrhoses and hepatocellular carcinoma. However, chronic infection is often asymptomatic even in the presence of liver damage discernible on biopsy. The principle of rapid HCV antibody test is chromatographic immunoassay containing membrane coated with purified recombinant HCV proteins were employed to specifically identify anti-HCV with extremely high sensitivity. The test employs recombinant antigens (E.coli) analogous to structural (HCV-core-Ag) and non-structural (HCV-NS3-Ag, HCV-NS4-Ag & HCV-NS5-Ag) proteins of viral hepatitis C. Colloidal gold conjugated goat anti-human IgM and mouse anti-human IgG are dried and immobilized on the fiberglass strip. HCV antigens are immobilized at the Test Zone (T) and goat anti mouse IgG antibodies are immobilized at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HCV antibodies will bind the gold conjugated anti-human IgG and/or IgM forming complexes. These complexes will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HCV antigens to form a visible red line. The un-bound gold conjugate will continue to move and bind with goat anti-mouse IgG at the Control Zone (C) forming a visible red line. If no HCV antibodies in sample, a red line is only appeared at the Control Zone (C), which indicates the validity of the test.

HBV Panel (5 in 1) HBsAg, HBsAb HBeAg HBeAb HBcAb

 

Hepatitis B Surface Antigen (HBsAg) Rapid Test

 

(Serum/Plasma/Whole Blood)  

Intended Use:

Biocan Tell Me Fast One Step Hepatitis B Surface Antigen (HBsAg) Test is a rapid and convenient immunochromatographic in vitro assay for detection of HBsAg in human serum, plasma and whole blood. The test provides a visual, qualitative result, and all positive specimens must be confirmed with other qualified assays.  

Summary and Principle:

HBsAg consists of lipid, carbohydrate and protein. The protein moiety of HBsAg contains several polypeptides. The antigenic determinants on the protein moiety of the HBsAg determine the specific characteristics of the different serotypes of the virus and is the basis of the immunoassay. The antigenic reactivity of HbsAg is also associated with the surface of spherical or tubular particles. HbsAg is a fragment of the viral lipoprotein capsid. Tell Me Fast HBsAg test is an antibody sandwich immunoassay. Colloidal gold conjugated monoclonal antibodies reactive to HBsAg (sAb-Au) are dry-immobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion trough the strip rehydrating the gold conjugate. If present, HBsAg will bind with the gold conjugated antibodies forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-HBs antibodies immobilized there and a visible red line appears. If there is no HBsAg in sample, no red line will appear in the Test Zone (T). The gold conjugate will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat, anti-mouse IgG antibody and aggregating in a red line, which indicates the validity of the test.

Hepatitis B Surface Antigen (HBsAg) Rapid Test

 

(Serum/Plasma)  

Intended Use:

Biocan Tell Me Fast One Step Hepatitis B Surface Antigen (HBsAg) Test is a rapid and convenient immunochromatographic in vitro assay for detection of HBsAg in human serum and plasma. The test provides a visual, qualitative result, and all positive specimens must be confirmed with other qualified assays.  

Summary and Principle:

HBsAg consists of lipid, carbohydrate and protein. The protein moiety of HBsAg contains several polypeptides. The antigenic determinants on the protein moiety of the HBsAg determine the specific characteristics of the different serotypes of the virus and is the basis of the immunoassay. The antigenic reactivity of HbsAg is also associated with the surface of spherical or tubular particles. HbsAg is a fragment of the viral lipoprotein capsid. Tell Me Fast HBsAg test is an antibody sandwich immunoassay. Colloidal gold conjugated monoclonal antibodies reactive to HBsAg (sAb-Au) are dry-immobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion trough the strip rehydrating the gold conjugate. If present, HBsAg will bind with the gold conjugated antibodies forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-HBs antibodies immobilized there and a visible red line appears. If there is no HBsAg in sample, no red line will appear in the Test Zone (T). The gold conjugate will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat, anti-mouse IgG antibody and aggregating in a red line, which indicates the validity of the test.

Anti-Treponema Pallidum (Syphilis) Rapid Test

 

(Serum/Plasma/Whole Blood)  

Intended Use:

Biocan Tell Me Fast Treponema Pallidum (TP) Antibody Test is a rapid and convenient immunochromatographic in vitro assay for qualitative determination of TP (Syphilis) IgG and IgM antibodies in human serum plasma or whole blood. It is intended for professional use as an aid in the diagnosis of Syphilis. This assay provides only a preliminary result and all results should be confirmed with other qualified assays.  

Summary and Principle:

The spirochete treponema pallidum (TP) is the pathogen of a sexually transmitted disease to cause Syphitis. As this organism cannot be cultured on artificial media, the diagnosis of syphitis depends on the correlation of clinical data with the specific antibody demonstrated by serological tests. Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of syphitis. Primary syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment. Tell Me Fast One Step TP Antibody Test employs the use of an antibody binding protein conjugated to a colloidal gold particle and combination of TP 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 TP 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), which indicates the validity of the test.

Anti-Treponema Pallidum (Syphilis) Rapid Test

 

(Serum/Plasma)  

Intended Use:

Biocan Tell Me Fast Treponema Pallidum (TP) Antibody Test is a rapid and convenient immunochromatographic in vitro assay for qualitative determination of TP (Syphilis) IgG and IgM antibodies in human serum or plasma. It is intended for professional use as an aid in the diagnosis of Syphilis. This assay provides only a preliminary result and all results should be confirmed with other qualified assays.  

Summary and Principle:

The spirochete treponema pallidum (TP) is the pathogen of a sexually transmitted disease to cause Syphitis. As this organism cannot be cultured on artificial media, the diagnosis of syphitis depends on the correlation of clinical data with the specific antibody demonstrated by serological tests. Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of syphitis. Primary syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment. Tell Me Fast One Step TP Antibody Test employs the use of an antibody binding protein conjugated to a colloidal gold particle and combination of TP 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 TP 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), which indicates the validity of the test.

Chlamydia Antigen Rapid Test

 

A rapid test for the qualitative detection of Chlamydia antigen in female cervical swab, male urethral swab and male urine specimens. For professional in vitro diagnostic use only.

Intended Use:

TELL ME FAST Chlamydia Test Device is a rapid and sensitive direct binding test for visual detection of Chlamydia trachomatis antigen in female cervical swab, male urethral swab and male urine specimens to aid in the diagnosis of Chlamydia infection. This test if for professional use only and is a preliminary screening test and results should be confirmed with other qualified assays.  

Summary and Principle:

Chlamydia trachomatis is one of the most common sexually transmitted pathogens. It is a major cause of cervicitis, urethritis, endometritis and pelvic inflammatory disease in women. Serious complications can result in salpingitis, infertility and ectopic pregnancy. If transmitted to infants during birth, chlamydia can cause conjunctivitis and pneumonia. 50 to 70 percent of infected women are asymptomatic, which makes diagnosis extremely important. Chlamydia are related to gram-negative bacteria. They are intracellular in nature and are unable to synthesize adenosine triphosphate (ATP). The extracellular elementary body form is infectious while the intracellular reticulate form is metabolically active. Epidemiological patterns indicate infections of Chlamydia trachomatis parallel or exceed those of Neisseria gonorrhea and the two often occur together. The disease cuts across the socioeconomic spectrum. The primary method for detection of Chlamydia is growth of the organism in cell culture. Other methods include direct fluorescence assays (DFA), Enzyme Immunoassays (EIA) and nucleic acid probing. The TELL ME FAST Chlamydia Test Device utilizes the chemical extraction of a carbohydrate antigen from chlamydia followed by the utilization double sandwich immunoassay for the qualitative detection of Chlamydia trachomatis antigen. The assay is conducted by adding pre-treated specimen to the sample well of the cassette and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored dried conjugate of colloidal gold-monoclonal antibody. The sample reconstitutes the dried conjugate. If Chlamydia trachomatis antigen is present in the sample, it will react with the antibody to form a complex of colloidal gold-monoclonal antibody-Chlamydia. This complex migrates up the membrane strip chromatographically and through the band of immobilized antibody. Because the immobilized antibody is able to bind to the Chlamydia trachomatis antigen molecule of the migrating complex, a visible reddish band is formed along the exact location of the immobilized antibody. If there is no Chlamydia trachomatis antigen present in the treated sample, the colloidal gold-monoclonal antibody conjugate will pass through the immobilized antibody band and no colored line will form – a negative test result. Further up the membrane, pass the test region, is a control region. This band of antibody will bind only conjugate and form a colored line, regardless of whether Chlamydia trachomatis antigen is present in the sample or not. Appearance of the control line assures reagent integrity as well as correct testing procedure.

Neisseria Gonorrhoeae Rapid Test

CE APPROVED

 

A rapid direct binding test for visual detection of Neisseria Gonorrhea antigen in urethral/genital swab specimens. For professional in vitro diagnostic use only.

Intended Use:

Biocan TELL ME FAST Gonorrhea Test Device (swab) is a rapid and sensitive direct binding test for visual qualitative detection of Neisseria Gonorrhea antigen in urethral/genital swab specimens. This test provides only a preliminary result and is not a confirmatory test and clinical expertise should be sought to further evaluate the result of this test.  

Summary and Principle:

Gonorrhea, caused by the bacterium Neisseria gonorrhoeae (NGH), is one of the most commonly occurring sexually transmited disease (STDs). It occurs simultaneously in around 50% of cases with Chlamydia or non-gonococcal urethritis (NGU) depending on the sex of the individual infected. Gonorrhea is spread by sexual contact and can also be spread by vertical transmission from mother to a newborn baby. Gonorrhea is treatable with some antibiotics, but antibiotic-resistant strains are now becoming more common. TELL ME FAST Gonorrhea Test Device is a rapid direct binding test that qualitatively detects the presence of gonorrhea antigen in secretory specimen from urogenital system. The test utilizes monoclonal antibodies to selectively detect gonorrhea antigen in secretory specimen. The TELL ME FAST Gonorrhea Test (swab) shows no cross-reactivity interference from any medication that is being taken. The detection limit of Biocan NGH Test Kit is 104 cfu/ml. Samples contain Neisseria Gonorrhea at equal to or greater than 104 cfu/ml will be tested positive. Biocan TELL ME FAST Gonorrhea Test Device (swab) is a rapid direct binding test based on the principle of a double sandwich immunoassay for the qualitative detection of gonorrhea antigen in secretory specimen to aid in the early detection of gonococcus infection. The assay is conducted by adding pre-treated specimen to the sample well of the cassette and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored dried conjugate of colloidal gold-monoclonal antibody. The sample reconstitutes the dried conjugate. If gonococcus antigen is present in the sample, it will react with the monoclonal antibody to form a complex of colloidal gold-monoclonal antibody-gonorrhea. This complex migrates up the membrane strip chromatographically and through the band of immobilized antibody. Because the immobilized antibody is able to bind to the gonococcus antigen molecule of the migrating complex, a visible reddish band is formed along the exact location of the immobilized antibody. If there is no gonococcus antigen is present in the treated sample, the colloidal gold-monoclonal antibody conjugate will pass through the immobilized antibody band and no colored line will form – a negative test result. Further up the membrane, past the test region, is a control region. This band of antibody will bind only conjugate and form a colored line, regardless of whether gonococcus antigen is present in the sample or not. Appearance of the control line assures reagent integrity as well as correct testing procedure.

Product dispayed are not for sale in Canada Biocan Diagnostics Inc. © 2018. All rights reserved.