The Revogene C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection. The Revogene C. difficile assay is intended to aid in the diagnosis of CDI.

The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM Broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes Automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. it is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The revogene Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens. The revogene Strep A assay is intended for use as an aid in the diagnosis of the Group A Streptococcus infection.The revogene Strep A assay is intended for use in hospital, reference or state laboratory settings.

The revogene Carba assay performed on the revogene instrument is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings.

The Alethia™ CMV External Control Kit contains Positive and Negative Control Reagents for use with the Alethia CMV DNA Amplification Assay. External controls are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors.

The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.

The Alethia GBS External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Group B Streptococcus test kit. External controls are used as part of a routine quality control program.

The Alethia™ Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the Alethia™ Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia™ Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.

The Alethia™ C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the Alethia™ C. difficile test kit. External controls are used as part of a routine quality control program.

The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.

The Alethia™ HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.

The Alethia Malaria External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Malaria or Alethia Malaria PLUS DNA Amplification Assays. External controls are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors.

The Alethia™ C. difficile DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD). The Alethia™ C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile PaLoc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The Alethia™ C. difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.

The Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The Alethia™ Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the Alethia™ Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.

The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.The Alethia Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.Results from the Alethia Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the Alethia Mycoplasma Direct DNA Amplification Assay may be necessary.

The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

The Alethia™ HSV 1&2 DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Alethia™ HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from Alethia™ HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.

The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

The Alethia Malaria amplification assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic test for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection.Alethia Malaria assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assay does not distinguish between Plasmodium species.Alethia Malaria is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

The Alethia Malaria PLUS DNA amplification assays, performed on the Alethia Incubator/Reader, are qualitative in vitro diagnostic tests for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection.Alethia Malaria assays utilize loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assays do not distinguish between Plasmodium species.Alethia Malaria PLUS is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

The Alethia CMV Assay Test System includes separately provided test kits for the Alethia CMV DNA Amplification Assay and the Alethia CMV External Control Reagents.The Alethia CMV DNA Amplification Assay, performed on the Alethia instrument, is a qualitative, in vitro diagnostic test system for the direct detection of Cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age. The test is used as an aid in the diagnosis of congenital CMV infection. The results of this test should be used in conjunction with the results of other clinical findings.Flocked swabs should be used to collect saliva from neonates. The swab can be collected dry, without viral transport media (VTM), or placed in no more than 1 mL VTM.The Alethia CMV External Control Reagents are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors. The external controls are intended for use with the Alethia CMV DNA Amplification Assay; the controls are not intended for use with other assays or systems.

Premier Adenoclone-Type 40/41 is an enzyme immunoassay (EIA) for the qualitative detection of enteric adenovirus serotypes 40 and 41 in human fecal specimens.

Premier Adenoclone is an Enzyme immunoassay (EIA) for the qualitative detection of human adenoviruses directly from stool specimens and confirms the presence of adenovirus in cell culture isolates from respiratory, ophthalmic or enteric specimens.

The ImmunoCard Mycoplasma enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgM to Mycoplasma pneumoniae in human serum. Test results are intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. The ImmunoCard H. pylori assay may be performed in clinical laboratories and physician's offices.

ImmunoCard Toxins A & B is a rapid, qualitative, horizontal-flow enzyme immunoassay (EIA) for detecting Clostridium difficile Toxins A and B in human stool. This assay is used as an aid in the diagnosis of C. difficile-associated disease.In the US, ImmunoCard Toxins A & B is not intended for point-of-care use. The device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.

ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.

The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.

The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates.In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.

FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program

TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to be used by clinical laboratories to test specimens from symptomatic patients aged five years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture. The results of this test are used in combination with other clinical tests and the patients’ conditions to diagnose RSV-associated infections.

Curian HpSA, for use with the Curian Analyzer is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen in human fecal specimens. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in human stool from patients with signs and symptoms of gastroenteritis. The test is intended for use with unpreserved fecal specimens or preserved fecal specimens in transport media. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures. Curian Campy is intended to aid in the diagnosis of Campylobacter infection.

The Meridian CON-Trate system is a complete system for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces.

The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.

The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.

The Meridian CON-Trate System is a complete system for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces.

The Meridian CON-Trate System is a complete system for concentrating and recovering helminth eggs, larvae and protozoan cysts from feces.

The Meridian CON-Trate System is a complete system for concentrating and recovering helminth eggs, larvae and protozoan cysts from feces.

Components for Stool Concentration System

The Meridian Para-Pak CON-Trate system is a complete system for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces

Para-Pak Macro-CON is a system for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. The filtration unit is designed to be used directly with the Para-Pak specimen collection vial. This creates a completely closed system, minimizing exposure of the user to potentially infectious agents. Macro-CON concentration utilizes the entire contents of the Para-Pak specimen collection vial, reducing variation due to specimen sampling. This is of particular advantage to the clinical parasitologist when a small number of organisms may be present in a large volume of stool.

Para-Pak SpinCon is a unique, patented system for the concentration of parasite eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin and EcoFix may be used with this system.

Para-Pak SpinCon is a unique, patented system for the concentration of parasite eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF) and EcoFix may be used with this system.

Para-Pak SpinCon is a unique patented system for the concentration of parasite eggs, larvae, and protozoa from preserved fecal specimens.

An immunofluorescence test for the detection of EBV VCA IgG Antibodies to Epstein-Barr Virus.

The MERIFLUOR EBV VCA IgM IFA Test is a sensitive and rapid immunofluorescence method for the qualitative detection of antibodies to the Viral Capsid Antigen (VCA) of Epstein-Barr virus (EBV) in human serum. It is of value in providing supportive information for the diagnosis of active infection with EBV.

Slides for the detection of EBV VCA IgG/IgM.

The MERIFLUOR EBV-NA Test is a rapid, sensitive anti-complement immunofluorescence (ACIF) test for the qualitative or quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human serum. The test can provide valuable diagnostic information to facilitate patient management when used in conjunction with other EBV antibody tests.

Bulk Ethyl Acetate used within Meridian's CON-Trate Stool Concentration Systems