Calprotectin Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast Calprotectin Rapid test is an immunochromatographic test or the semiquantitative detection of human calprotectin (hCp) in human stool samples that may reflect gastrointestinal inflammation caused by several pathologies (inflammatory bowel disease, colorectal cancer and some enteropathies). This test offers a simple, a highly sensitivity and non-invasive screening assay to determine intestinal inflammatory activity, to monitor treatment response and to predict risk of relapse. This is a screening test and all results must be confirmed with other qualified assays.

Summary and Principle:

Calprotectin is a 36kDa calcium and zinc binding protein expressed by the gene S100 calciumbinding protein A8, S100A8. It accounts for 30 to 40% of neutrophils' cytosol. In vitro studies show it has bacteriostatic and fungistatic properties. It is resistant to enzymatic degradation, and can be easily measured in faeces. Calprotectin is released by activation of leukocytes, giving increased levels in plasma, cerebral spinal fluid, synovial fluid, urine or stools as a consequence of disease in the relevant organ(s). Calprotectin inhibits zinc-dependent enzyme systems, as a result kills microbes and induces apoptosis in normal and cancer cells. In the presence of calcium, calprotectin is remarkably resistant to protelolytic degradation and so is stable in stools kept at room temperature for 7 days. Biocan Tell Me Fast Calprotectin test employs red gold-conjugated monoclonal antibodies against human calprotectin, and solid-phase specific another calprotectin antibodies. In this test the specimen is first treated with an extraction solution to extract calprotectin from the faces/stool. Following extraction, the only step required is to add the extract to the reaction device. As the sample flows through the test membrane, the colored particles migrate. In the case of a positive result, the specific antibodies present on the membrane will capture the colored particles. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. These lines, after 5-15 minutes of incubation at room temperature, are used to interpret the result.

Performance Characteristics:

Sensitivity: Tell Me Fast Biocan Calprotectin test can detect calprotectin at 500ng/ml diluted in extraction buffer provided (50μg hCp/g of Faeces). Specificity: Tell Me Fast Biocan Calprotectin is 99.8% specific for human calprotectin, showing no cross-reaction with calprotectin from bovine, sheep, goat, horse and pig.  

Calprotectin – Lactoferrin Combo Rapid Test

CE APPROVED

 

Procalcitonin Rapid Test

CE APPROVED

 

Campylobacter Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast Campylobacter Rapid test is an immunochromatographic test for quantitative detection of Campylobacter (C. jejuni and C. coli) in stool in human stool samples. This test offers a simple, a highly sensitivity and non-invasive screening assay to determine intestinal inflammatory activity, to monitor treatment response and to predict risk of relapse. This is a screening test and all results must be confirmed with other qualified assays.

Summary and Principle:

Campylobacter is a gram-negative, microaerophillic bacterium. Virtually all human illness is caused by one or two species. These two species are C. coli and C. jejuni. The Centers for Disease Control (CDC) reports that 99% of illness is caused by C. jejuni while other studies have shown that globally, more than 90% of Campylobacter infections are caused by C. jejuni, followed by C. coli with 5-10%.The disease caused by the genus Campylobacter is referred to as Campylobacteriosis. Most people with Campylobacteriosis get diarrhea, cramping, abdominal pain, and fever within two to five days after exposure to the organism. Diarrhea may be bloody and can be accompanied by nausea and vomiting. The illness typically lasts one week. Some persons who are infected with Campylobacter don't have any symptoms at all. In persons with compromised immune systems, Campylobacter occasionally spreads to the bloodstream and causes a serious life-threatening infection. Campylobacter is one of the most common bacterial causes of diarrheal illness in the United States. Virtually all cases occur as isolated, sporadic events, not as a part of large outbreaks. Active surveillance through FoodNet indicates about 15 cases are diagnosed each year for every 100,000 persons in the population. Many more cases go undiagnosed or unreported, and Campylobacteriosis is estimated to affect over one million persons every year, or 0.5% of the general population. Campylobacteriosis occurs much more frequently in the summer months than in the winter. The organism is isolated from infants and young adults more frequently than from other age groups and from males more frequently than females. Although Campylobacter doesn't commonly cause death, it has been estimated that approximately 100 persons with Campylobacter infections may die each year. Biocan Tell Me Fast Campylobacter test employs red gold-conjugated monoclonal antibodies against human camplylobacter, and solid-phase specific another calprotectin antibodies. In this test the specimen is first treated with an extraction solution to extract campylobacter from the faces/stool. Following extraction, the only step required is to add the extract to the reaction device. As the sample flows through the test membrane, the colored particles migrate. In the case of a positive result the specific antibodies present on the membrane will capture the colored particles. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. These lines, after 5-15 minutes of incubation at room temperature, are used to interpret the result.

Performance Characteristics:

Sensitivity: Tell Me Fast Biocan Campylobacter test detection limit values for the different species are 1.07x10⁶ CFU/mL for Campylobacter jejuni and 1.07x10⁸ CFU/mL for Campylobacter coli. Specificity: Tell Me Fast Biocan Campylobacter test is 99% specific for human calprotectin, showing no cross-reaction with calprotectin from bovine, sheep, goat, horse and pig.  

C. diffcile Toxin A/B Combo Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast Clostridium difficile antigen rapid test is an immunochromatographic test for the quantitative detection of Clostridium Difficile Toxin A & B in stool samples. This test offers a simple, a highly sensitivity and non-invasive screening assay to determine Clostridium difficile infection. This is a screening test and all results must be confirmed with other qualified assays.

Summary and Principle:

Clostridium difficile is an anaerobic gram-positive spore-forming bacillus. The key feature in enabling it to persist in patients and the physical environment for long periods and thereby facilitating its transmission is the ability of C. difficile to form spores. C. difficile is transmitted through the fecal-oral route. Clostridium difficile is the principal pathogen related to antibiotic associated diarrhea and/or pseudomembranous colitis in hospitalized patients. Mature colonic bacterial flora in a healthy adult is generally resistant to C. difficile colonization. However, if the normal colonic flora is altered, resistance to colonization is lost. Thus, any factor associated with alteration of the normal enteric flora increases the risk of C. difficile colonization after exposure to antibiotics, especially those with broadspectrum activity such as penicillins, cephalosporins and clindamycin. C. difficile can release two high-molecular- weight toxins, toxin A and toxin B, which are responsible for the clinical manifestations, which range from mild, self-limited watery diarrhea to fulminant pseudomembranous colitis, toxic megacolon, and death. Biocan Tell Me Fast Clostridium difficile antigen Toxin & B rapid test employs red goldconjugated monoclonal antibodies against antigen Toxin A & B of C. difficile, and solid-phase specific another c.difficile antibodies. In this test the specimen is first treated with an extraction solution to extract Toxin A & B antigens from the faces/stool. Following extraction, the only step required is to add the extract to the reaction device. As the sample flows through the test membrane, the colored particles migrate. In the case of a positive result, the specific antibodies present on the membrane will capture the colored particles. Red color lines will be visible, depending upon the virus content of the sample. These lines, after 5-15 minutes of incubation at room temperature, are used to interpret the result.

Performance Characteristics:

Analytical sensitivity (detection limit): Detection limit value of Biocan Clostridium difficile antigen test for Toxin A is 2 ng/mL and Toxin B is 0.70.

C. diffcile Toxin B Rapid Test

CE APPROVED

 

C. diffcile Toxin A Rapid Test

CE APPROVED

Clostridium difficile GDH Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast Clostridium difficile antigen GDH Rapid test is an immunochromatographic test for the quantitative detection of Clostridium Difficile Glutamate Dehydrogenase (GDH) in stool samples. This test offers a simple, a highly sensitivity and non-invasive screening assay to determine Clostridium difficile infection. This is a screening test and all results must be confirmed with other qualified assays.

Summary and Principle:

Clostridium difficile is an anaerobic gram-positive spore-forming bacillus. The key feature in enabling it to persist in patients and the physical environment for long periods and thereby facilitating its transmission is the ability of C. difficile to form spores. C. difficile is transmitted through the fecal-oral route. Clostridium difficile is the principal pathogen related to antibiotic associated diarrhea and/or pseudomembranous colitis in hospitalized patients. Mature colonic bacterial flora in a healthy adult is generally resistant to C. difficile colonization. However, if the normal colonic flora is altered, resistance to colonization is lost. Thus, any factor associated with alteration of the normal enteric flora increases the risk of C. difficile colonization after exposure to antibiotics, especially those with broadspectrum activity such as penicillins, cephalosporins and clindamycin. C. difficile can release two high-molecular- weight toxins, toxin A and toxin B, which are responsible for the clinical manifestations, which range from mild, self-limited watery diarrhea to fulminant pseudomembranous colitis, toxic megacolon, and death. Clostridium difficile Glutamate Dehydrogenase (GDH) is an enzyme produced in large quantities by all toxigenic and non-toxigenic strains, making it an excellent marker for the organism. Biocan Tell Me Fast Clostridium difficile antigen GDH rapid test employs red gold-conjugated monoclonal antibodies against antigen GDH of C. difficile, and solid-phase specific another GDH antibodies. In this test the specimen is first treated with an extraction solution to extract GDH anigens from the faces/stool. Following extraction, the only step required is to add the extract to the reaction device. As the sample flows through the test membrane, the colored particles migrate. In the case of a positive result the specific antibodies present on the membrane will capture the colored particles. Red color lines will be visible, depending upon the virus content of the sample. These lines, after 5-15 minutes of incubation at room temperature, are used to interpret the result.

Performance Characteristics:

Sensitivity & Specificity: The sensitivity of Biocan Tell Me Fast Clostridium difficile antigen GDH Rapid test is 99.3% and specificity is 99%. Analytical sensitivity (detection limit): Detection limit value of Biocan Clostridium difficile antigen GDH test is 0.8 ng/mL.  

Adenovirus/Rotavirus Antigen Combo Test

CE APPROVED

 

Rotavirus Antigen Test

CE APPROVED

Adenovirus Antigen Test

CE APPROVED

Clostridium difficile GDH Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast Giardia Rapid test is an immunochromatographic test for quantitative detection of Giardia antigens in human stool samples. This is a screening test and all results must be confirmed with other qualified assays.

Summary and Principle:

Giardia is a microscopic parasite that causes the diarrheal illness known as giardiasis. Giardia (also known as Giardia intestinalis, Giardia lamblia, or Giardia duodenalis) is found on surfaces or in soil, food, or water that has been contaminated with feces (poop) from infected humans or animals. Giardia is protected by an outer shell that allows it to survive outside the body for long periods of time and makes it tolerant to chlorine disinfection. While the parasite can be spread in different ways, water (drinking water and recreational water) is the most common mode of transmission.

Performance Characteristics:

The Sensitivity of this test is 96.5% and Speficity is 99%.   No cross reactivity was observed with the Biocan Tell Me Fast Giardia Rapid test with the below mentioned gastrointestinal pathogens which are found in human faeces.  

Adenovirus type II

Campylobacter coli

Campylobacter fetus

Citrobacter freundii

Clostridium perfringens

Escherichia fergusonii

Klebsiella pnumoniae

Shigella dysenteriae

Shigella flexneri

Serratia liquefaciens

Staphylococcus aureus (Cowan)

Staphylococcus galactiae

Campylobacter jejuni

Campylobacter lari

Candida albicans

Clostridium difficile

Enterococcus feacalis

Escherichia hermanii

Mycobacterium smegmatis

Shigella sonnei

Staphylococcus epidermidis

Staphylococcus aureus

Staphylococcus faecalis

Yersinia enterocolitica

Norovirus Antigen Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast Norovirus Test Device (Stool) is a rapid chromatographic immunoassay for the qualitative detection of Norovirus Genogroup I & II antigens in human stool. This is a preliminary screening test and are results must be verified with other qualified assays.

Summary and Principle:

Noroviruses (NoV) are a genetically diverse group of single stranded RNA, nonenveloped viruses belonging to the Caliciviridae family. For decades, they were called “small round structured viruses” (SRSV) or “Norwalk-like viruses” until recently when their taxonomy was investigated using modern molecular techniques. Initially four antigenic types of SRSV were recognized, but more recently three genogroups have been identified with the genus Norovirus. Genogroup 1 and Genogroup 2 are associated with human infections whilst Genogroup 3 is associated with bovine and porcine infection. Noroviruses are a major cause of acute gastroenteritis worldwide, often causing explosive outbreaks in institutions. They are highly contagious, with an inoculum of as few as ten particles being able to cause infection. Transmission occurs through ingesting contaminated food and water and by person-to-person spread. Transmission is predominantly fecal-oral but may be airborne due to aerosolization of vomitus, which typically contains abundant infectious virus particles. Outbreaks may involve several routes of transmission. The illness is acute, usually mild, although it has caused fatalities among the frail elderly, and self-limiting and follows an incubation period of 24-48 hours although cases can occur within 12 hours of exposure. The ability of Noroviruses to cause outbreaks in institutions has become a major public health issue. Outbreaks of Norovirus infection can be associated with restaurants and institutions as diverse as nursing homes, hospitals and elite sporting camps. Infections in infants, elderly or frail patients can be fatal if left untreated. The symptoms of norovirus illness usually include nausea, vomiting, diarrhea, and some stomach cramping. Sometimes people additionally have a low-grade fever, chills, headache, muscle aches, and a general sense of tiredness. The illness often begins suddenly, and the infected person may feel very sick. In most people the illness is self-limiting with symptoms lasting for about 1 or 2 days. In general, children experience more vomiting than adults.

Performance Characteristics:

Clinical evaluation was conducted comparing the results obtained using the Biocan Tell Me Fast Norovirus Rapid Test (Stool) to a commercially available stool PCR test. Sensitivity & Specificity: Biocan Tell Me Fast Norovirus Test Device (Stool) demonstrated sensitivity of 94% and specificity of 99%. Analytical sensitivity (detection limit): Detection limit value of Biocan Norovirus Antigen test is 12 ng/mL for Norovirus GI and 5 ng/mL for Norovirus GII.

A rapid test for the qualitative detection of Norovirus antigens (genogroup GI & GII) in stool samples. For professional in vitro diagnostic use.

FOB – Transferrin Combo Rapid Test

CE APPROVED

 

Fecal Occult Blood (FOB) Rapid Test

CE APPROVED

 

Entamoeba Rapid Test

CE APPROVED

 

E.Coli O157 Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast E.Coli O157:H7 Rapid test is an immunochromatographic test for quantitative detection of Escherichia.Coli O157:H7 Antigens in human stool samples. This test offers a simple, a highly sensitivity and non-invasive screening assay to determine a presumptive diagnosis of E.Coli infection. This is a screening test and all results must be confirmed with other qualified assays.

Summary and Principle:

E. coli O157, predominately O157:H7, has been implicated as the causative organism of hemolytic uremic syndrome (HUS) and hemorrhagic colitis (HC). HUS syndrome is characterized by microangiopathic hemolytic anemia, thrombocytopenia and renal failure while HC typically presents with abdominal cramps and watery diarrhea followed by a hemorrhagic discharge resembling lower gastrointestinal bleeding. Typically diagnosis has been done by culturing on sorbitol-MacConkey medium and then using typing antiserum. However, current latex assays and some typing antiserum have shown cross reactions with non-E. coli O157 colonies. Furthermore, not all E. coli O157 strains associated with HUS are nonsorbitol fermentors. Both syndromes have been associated with E. coli O157 and O157:H7 but are not limited to these organisms. These syndromes appear to be more closely linked to any organism that produces Shiga-like toxins. The E. coli O157 outbreaks are believed to be passed by the fecal oral route and have been isolated in an increasing number of food related poisonings involving undercooked beef and dairy products. The Council of State and Territorial Epidemiologists recommend that clinical laboratories screen at least all bloody stools for this pathogen. The American Gastroenterological Association Foundation (AGAF) recommended in July 1994 that all stool specimens should be routinely tested for E. coli O157:H7.15 It is recommended that the clinician check with their state health department or the Centers for Disease Control and Prevention to determine which specimens should be tested and whether the results are reportable. Biocan Tell Me Fast E.Coli O157:H7 rapid test employs red gold-conjugated E.Coli 0157 monoclonal antibodies. In this test the specimen is first treated with an extraction solution to extract E.Coli from the faces/stool. Following extraction, the only step required is to add the extract to the reaction device. As the sample flows through the test membrane, the colored particles migrate. In the case of a positive result the specific antibodies present on the membrane will capture the colored particles. Red color lines will be visible, depending upon the virus content of the sample. These lines, after 5-15 minutes of incubation at room temperature, are used to interpret the result.

Performance Characteristics:

Analytical sensitivity (detection limit): The detection limit of this test is 1.87 x 10⁴ CFU/mL Sensitivity & Specificity: Tell Me Fast Biocan E.Coli O157:H7 test sensitivity is 98% and specificity in 94.5%.

Lactoferrin Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast Lactoferrin Rapid test is an immunochromatographic test for the quantitative detection of human lactoferrin (hLf) in human stool samples that may reflect gastrointestinal inflammation caused by several pathologies (inflammatory bowel disease, colorectal cancer and some enteropathies). This test offers a simple, a highly sensitivity and non-invasive screening assay to determine intestinal inflammatory activity, to monitor treatment response and to predict risk of relapse. This is a screening test and all results must be confirmed with other qualified assays.

Summary and Principle:

Lactoferrin (LF), also known as lactolactoferrin (LTF), is a multifunctional protein of the lactoferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears, and nasal secretions. Lactoferrin is also present in secondary granules of PMN and is secreted by some acinar cells. Lactoferrin can be purified from milk or produced recombinantly. Human colostrum ("first milk") has the highest concentration, followed by human milk, then cow milk (150 mg/L). Lactoferrin is a glycoprotein component of neutrophil secondary granules, a primary component of the acute inflammatory response and is released from fecal leukocytes. This protein is resistant to proteolysis in the faeces and may serve as a marker of inflammation in the intestine. The major cause of fecal neutrophils in patients with chronic diarrhea is chronic inflammatory bowel disease of the colon (i.e., Crohn’s Disease and ulcerative colitis). Lactoferrin has been also studied as a predictor of infection with invasive enteropathogens in children with diarrhoea.Bacterial inflammatory diarrhea may be caused by Shigella, Salmonella, Campylobacter and Biocan Tell Me Fast Lectoferrin test employs red gold-conjugated monoclonal antibodies against human lactoferrin, and solid-phase specific another lactoferrin antibodies. In this test the specimen is first treated with an extraction solution to extract lactoferrin from the faces/stool. Following extraction, the only step required is to add the extract to the reaction device. As the sample flows through the test membrane, the colored particles migrate. In the case of a positive result, the specific antibodies present on the membrane will capture the colored particles. Red color lines will be visible, depending upon the virus content of the sample. These lines, after 5-15 minutes of incubation at room temperature, are used to interpret the result.

Performance Characteristics:

Sensitivity: Tell Me Fast Biocan Lactoferrin test can detect leactoferrin at 100ng/ml (10ug Lactoferrin/g feces) diluted in extraction buffer provided. Specificity: Tell Me Fast Biocan Lectoferrin is 99.8% specific for human calprotectin, showing no cross-reaction with lectoferrin from bovine, sheep, goat, horse and pig.

Transferrin Rapid Test

CE APPROVED

 

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