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The Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device is intended to preserve the viability and infectivity of fecal specimens after their collection and during transport from the collection site to the testing laboratory. The product can be used to collect stool specimen directly from the patient, using the swab as a rectal swab. Alternatively, the swab can be used to take material from a previously collected stool specimen. Fecal Transwab® specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

Each Fecal Transwab® Liquid Cary Blair Medium Collection and Transport Device comprises a sterile peel pouch containing a plastic screw-cap self standing tube with conical shaped bottom filled with 2 ml of Liquid Cary Blair transport medium and a specimen collection swab with a polyurethane foam coated tip. After sampling the swab applicator is placed in the tube where the bud is bathed in the liquid medium. The swab shaft is broken to allow the swab to fit in the tube, with the screw-cap being replaced.

Fecal Transwab can also be supplied as a medium only device without a swab, in which case the specimen can be inoculated into the medium using a sterile swab, or scoop, or inoculating loop.

The Liquid Cary Blair transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium chloride and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability without overgrowth of enteric bacteria during transit to the testing laboratory.
The foam-tipped collection swab provided with the Medical Wire Fecal Transwab® Collection and Transport System has a plastic shaft with a defined breakpoint site. A bold red marker line indicates the limit of insertion if the swab is used to take a rectal specimen.

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The Flowflex® Plus Strep A Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

The Flowflex® Plus Strep A Rapid Test Strip is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

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The cobas® liat Bordetella panel nucleic acid test (cobas® liat Bordetella panel) is an automated real-time polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of Bordetella pertussis (Bp), Bordetella parapertussis (Bpp), and Bordetella holmesii (Bh) nucleic acid in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.

The test is meant to be used in conjunction with other clinical and epidemiological information and laboratory findings. When clinical factors suggest that B. pertussis, B. parapertussis or B. holmesii may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results do not preclude Bp, Bpp, or Bh infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out co-infection with other bacteria or viruses. The agent detected may not be the definite cause of disease.

The cobas® liat Bordetella panel nucleic acid test (cobas® liat Bordetella panel) is an automated multiplex real-time polymerase chain reaction (PCR) assay for the rapid in vitro qualitative detection and differentiation of B. pertussis (Bp), B. parapertussis (Bpp), and B. holmesii (Bh) DNA in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.

The different fluorescent dye designs enable the specific detection and differentiation of the three microorganisms (Bp, Bpp, and Bh) independently in a multiplex system. The system automates all nucleic acid amplification test sample processing steps, including inhibitor removal, nucleic acid extraction, purification, amplification, real-time detection, and result interpretation in a rapid manner. The test is designed for use in near-patient settings to deliver results in approximately 15 minutes.

The cobas® liat system is comprised of the cobas® liat analyzer (analyzer) hardware with integrated cobas® liat system software (analyzer software + liat assay specific package (script)) for running tests and analyzing the results, and a single-use disposable cobas® liat assay tube (assay tube).

• cobas® liat analyzer is a system component that consists of one software subsystem and three hardware units:

  • Infrastructure unit, which consists of the hardware and embedded software (firmware).
  • Thermal, loading and motion unit: the processing module that interacts physically with the assay tube during the assay execution.
  • Detection unit consisting of the photodetectors that is used for the fluorescence detection during the PCR reaction

• The assay script provides a set of instructions to the analyzer hardware and software for assay tube processing, PCR, result calculation and interpretation and result reporting. The assay script can be installed on the analyzer independently of the analyzer software.

The cobas® liat Bordetella panel nucleic acid test is supported with a Liat Assay Specific Package (Assay Script): cobas® liat Bordetella panel LASP (BPTA).

• The assay tube holds all reagents needed for sample preparation and PCR processes. The assay specific reagents are packaged into a single assay tube in separate segments that are separated by frangible seals. An internal control (IC) is also included. The IC is present to control for adequate processing of the target bacteria through all steps of the assay process and to monitor the presence of inhibitors in the PCR reaction.

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HardyDisk AST disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk AST Cefiderocol 30μg (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to cefiderocol, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

HardyDisk AST Cefiderocol at concentration 30μg demonstrated acceptable performance to determine the zone diameter (mm) of cefiderocol against the following microorganisms:

• Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, and Serratia marcescens)
• Pseudomonas aeruginosa
• Acinetobacter baumannii complex
• Stenotrophomonas maltophilia

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The Cytovale IntelliSep test is a semi-quantitative test that assesses cellular host response via deformability cytometry of leukocyte biophysical properties and is intended for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It is indicated for use in adult patients with signs and symptoms of infection who present to the Emergency Department. The test is performed on an EDTA anticoagulated whole blood sample.

The IntelliSep test generates an IntelliSep Index value that falls within one of three discrete interpretation bands based on the probability of sepsis with organ dysfunction manifesting within the first three days after testing. The IntelliSep test represents the probability of the clinical syndrome of sepsis and is intended to be used alongside other clinical information and clinical judgment. It does not identify the causative agent of infection and should not be used as the sole basis to determine the presence of sepsis. The IntelliSep test is intended for in vitro diagnostic use.

The Cytovale IntelliSep test is a short turn-around time (STAT) test, producing results in 10 minutes or less, to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It assesses the state of immune activation in patients with signs and symptoms of infection who present in the Emergency Department (ED). The IntelliSep test is run on the Cytovale System, a laboratory benchtop analyzer comprised of three modules: Sample Preparation Module, Cell Imaging Module, and Imaging Analysis Module. To run a test, the laboratory operator transfers 100 microL of whole blood into the sample preparation tube which is then placed into the Cytovale System. The system automatically lyses red blood cells, and washes the purified leukocytes in a diluent, producing a total volume of approximately 1mL of prepared sample, which the operator then transfers to the IntelliSep cartridge for analysis on the Cytovale System. A microfluidic deformability cytometry technique is used to measure the biophysical properties of thousands of individual leukocytes in rapid succession. These properties have been shown to differ in quiescent white blood cell populations when compared to those in septic patients, enabling rapid assessment of the host response and the likelihood of having sepsis with organ dysfunction manifesting within the first 3 days after testing. Based on these measurements, the test provides a single score, the IntelliSep Index (ISI), ranging from 0.1-10.0, stratified into three discrete interpretation bands (Band 1, Band 2, Band 3) of increasing sepsis likelihood.

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The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.

The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative detection of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems.

The Access Rubella IgG assay consists of the reagent pack, calibrators, and quality controls (QCs), packaged separately. Other items needed to run the assay include substrate and wash buffer.

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The Status COVID-19/Flu A&B test is a lateral flow immunoassay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from nasopharyngeal (NP) or anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions.

Positive results do not rule out bacterial infection or co-infection with other viruses.

The Status™ COVID-19/Flu A&B test is a lateral flow immuno-chromatographic assay which utilizes the chemical extraction of viral antigens followed by solid-phase immunoassay technology. The Status™ COVID-19/Flu A&B test is designed to detect antigens from SARS-CoV-2, influenza A, and/or influenza B in nasopharyngeal or anterior nasal swab specimens from individuals with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B viral infections. The Status™ COVID-19/Flu A&B test is validated for use with direct specimens without transport media.

In the test procedure, a nasopharyngeal or anterior nasal swab specimen is collected and placed into extraction reagent in the Extraction Well of the test device for one minute. During this time, the antigen is extracted from disrupted virus particles. The test device is then raised, tapped, and laid back down onto a level surface. Through this simple action, the solution of extracted specimen flows onto the test strip and migrates through the pads and membrane of the test strip. The pads contain detector antibodies conjugated to gold dye and the membrane contains immobilized capture antibodies. If SARS-CoV-2, influenza A, and/or influenza B antigens are present in the specimen, they will react with anti-SARS-CoV-2 antibody coupled to gold dye particles and/or anti-influenza antibody coupled to gold dye particles, migrate through the membrane as antigen-antibody-dye complexes, bind to the immobilized capture antibody line(s) on the membrane, and generate a colored line in the specific test line position. The rest of the sample and unbound/bound dye complexes continue to migrate to the Control line position (Ctrl), where immobilized antibodies to the anti-SARS-CoV-2 and anti-influenza antibodies capture the dye complexes and form the Control line. Formation of the Control line serves as an internal control to demonstrate that test reagents are functional, antibody-dye conjugates in the dye pad have been hydrated and released and that sufficient sample has been applied to allow for migration through the Test and Control lines. If the Control line does not appear within the designated incubation time, the result is invalid, and the test should be repeated using a new test device and specimen.

Status™ COVID-19/Flu A&B test has three Test lines, one for SARS-CoV-2 (CoV19), one for influenza A (Flu A), and one for influenza B (Flu B). The three Test lines allow for the differential identification of SARS-CoV-2, influenza A, and/or B from a single specimen. If any Test line appears in the test result window, together with the Control line, the test result is positive for SARS-CoV-2 and/or influenza. The test detects, but does not differentiate, between the SARS-CoV and SARS-CoV-2 viruses.

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