PORTFOLIO OF PRODUCTS
“BioGX offers a complete reagent solution that is simple for any sized lab, while offering high-quality, consistent and predictable performance.”
Marc Couturier, MD, Medical Director of Parasitology and Fecal Infection Disease Testing, ARUP
SIMPLE & EFFICIENT
Easily expand your test menu with 24 CE-IVD Marked products
SENSITIVE & COST EFFECTIVE
Ensure high performance testing
EASY-TO-USE
Enhance convenience and efficiency
BioGX makes it simple for any lab to easily expand its test menu with a large and robust menu of Sample-Ready™ offerings for CE-IVDs, combining all necessary reagents for each test – mixed and lyophilized – in one tube and ready to run on the BD MAX™ system.
Our Extensive Portfolio
Respiratory
400-002-C-MAX Bordetella Speciation Plus Toxin - OSR BD MAX™
Target Organism: Bordetella pertussis (IS481), B. parapertussis (pIS1001), B. holmesii (hIS1001), Pertussis toxin (ptxS1), SPC
Intended Use: The BioGX Bordetella Assay is intended as an aid in the diagnosis of Bordetella. Negative results do not preclude Bordetella and should not be used as the sole basis for treatment or other patient management decisions.
Clinical Significance: Pertussis, commonly referred to as “whooping cough”, is an infectious disease caused by the bacterium Bordetella pertussis. Before the availability of the pertussis vaccine in the 1940’s, more than 200,000 cases of pertussis were reported annually. Since widespread use of the vaccine began, incidence has decreased more than 75% compared with the pre-vaccine era. In recent years, there has been an increase in the number of reported cases that can be attributed to waning immunity from vaccines as well as the use of more sensitive diagnostics such as polymerase chain reaction (PCR).
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400-010-C-MAX Mycobacterium Tuberculosis Complex - OSR BD MAX™
Target Organism: Mycobacterium tuberculosis Complex (IS6110), SPC
Intended Use: The BioGX Mycobacterium tuberculosis Complex – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Mycobacterium tuberculosis Complex, and a DNA sample processing control (SPC). The assay is run on an automated DNA extraction and real-time PCR instrument with Pretreated Sputum or Bronchoalveolar Lavage (BAL) from individuals at risk for presence of Mycobacterium tuberculosis.
Clinical Significance: Tuberculosis (TB) is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but Mycobacterium tuberculosis can attack any part of the body such as the kidney, spine, and brain. Not everyone infected with Mycobacterium tuberculosis becomes sick. As a result, two TB-related conditions exist: latent TB infection (LTBI) and TB disease. If not treated properly, TB disease can be fatal.
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400-014-A-MAX Pneumocystis jirovecii - OSR BD MAX™
Target Organism: Pneumocystis jirovecii
Intended Use: The BioGX Pneumocystis jirovecii – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Pneumocystis jirovecii , and a DNA sample processing control (SPC). The assay is run on an automated DNA extraction and real-time PCR instrument with pretreated sputum from individuals at risk for presence of Pneumocystis pneumonia. Automated extraction of the sample DNA is done using the BD MAX™ ExK™ DNA-1 series extraction kits. The extraction kits contain the SPC DNA so no external addition of SPC is required. The SPC serves as both an extraction control and an internal amplification control (IAC). Each tube of multiplex PCR mix is provided in BioGX proprietary Sample-Ready™ lyophilized format and contains all PCR primers, probes, enzyme, dNTPs, MgCl, buffers, and other components required for real-time PCR-based analysis of one sample.
Clinical Significance: Pneumocystis pneumonia (PCP) is an opportunistic disease caused by invasion of the unicellular fungus Pneumocystis jirovecii. PCP is one of the most frequent and severe opportunistic infections in people with weakened immune systems. PCP was initially responsible for the majority of morbidity and mortality cases among HIV-infected patients, but this has since been significantly reduced with the advent of modern antiretroviral therapies. Pneumocystis pneumonia is still a significant cause of mortality among HIV-negative patients who are immunosuppressed, in particular for transplant and oncology patients. For non-immunosuppressed individuals, however, fungal invasion usually leads to asymptomatic colonization.
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400-020-C-MAX Bordetella pertussis/parapertussis - OSR BD MAX™
Target Organism: Bordetella pertussis (IS481), B. parapertussis (pIS1001), SPC
Intended Use: The BioGX Bordetella pertussis/parapertussis – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Bordetella pertussis, Bordetella parapertussis, and a DNA sample processing control (SPC). The assay is run on an automated DNA extraction and real-time PCR instrument with Nasopharyngeal (NP) swab or nasal wash samples from individuals at risk for presence of Bordetella.
Clinical Significance: Pertussis, commonly referred to as “whooping cough”, is an infectious disease caused by the bacterium Bordetella pertussis. Before the availability of the pertussis vaccine in the 1940’s, more than 200,000 cases of pertussis were reported annually. Since widespread use of the vaccine began, incidence has decreased more than 75% compared with the pre-vaccine era. In recent years, there has been an increase in the number of reported cases that can be attributed to waning immunity from vaccines as well as the use of more sensitive diagnostics such as polymerase chain reaction (PCR).
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400-033-C-MAX Group A Streptococcus - OSR BD MAX™
Target Organism: Streptococcus pyogenes (speB), SPC
Intended Use: The BioGX Group A Streptococcus – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Streptococcus pyogenes, and a DNA sample processing control (SPC).
Clinical Significance: Streptococcus pyogenes, also known as Group A Streptococcus (abbreviated GAS), is a strict human pathogen with prevalence worldwide causing greater than 750 million infections per year. S. pyogenes can cause a variety of different infections that exhibit different symptoms, but the vast majority are infections of the throat. Infections of the throat caused by S. pyogenes, also known as acute pharyngitis or strep throat, can occur in people of all ages but is most common among children 5-15 years old. S. pyogenes infections are responsible for approximately 20-30% of sore throats in children and 5-15% of sore throats in adults.
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| Title | Size | Download |
|---|---|---|
| UDP_Report_400033CMAX S4 | 32.54 KB | DownloadPreview |
| ENGLISH VERSION - 400-033-C-MAX_Group_A_Streptococcus_BVPI_Rev05_22SEP2023 | 1.00 MB | DownloadPreview |
| 400033CMAX S4_v1 | 12.49 KB | Download |
400-056-C-MAX Flu A, Flu B, RSV A/B - OSR for BD MAX™
Target Organism: Influenza A (matrix gene), Influenza B (nonstructural gene), Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, (nucleoprotein), SPC
Intended Use: Flu A, Flu B, RSV A/B – OSR for BD MAX™ is a multiplex real-time reverse transcriptase, polymerase chain reaction (PCR) assay for use on the BD MAX™ platform for the qualitative detection of the presence of RNA from Influenza A, Influenza B, RSV A and RSV B.
Clinical Significance: Influenza, also commonly known as the flu, is a contagious respiratory illness caused by the influenza virus. Influenza can cause mild to severe illness including, but not limited to, fever, cough, sore throat, muscle aches, and fatigue. Gastrointestinal symptoms such as vomiting and diarrhea may also occur, but these symptoms are more common in children.
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400-058-E-HMP SARS-CoV-2 HMP - N1, N2 & RNase P Multiplex
Target Organism: Nucleocapsid Phosphoprotein N1, Nucleocapsid Phosphoprotein N2, RNase P
IntendedUse: SARS-CoV-2 is the novel betacoronavirus that causes the COVID-19 respiratory disease. It is transmitted via talking, coughing and sneezing. Symptoms range from mild illness (dry cough, fatigue, fever and shortness of breath) to severe illness and death. COVID-19 was first identified on Dec. 31, 2019 amongst patients suffering from pneumonia in Wuhan, China. The elderly, immunocompromised and those with cardiovascular disease, diabetes and chronic respiratory disease have been shown to be at higher risk.
SARS-CoV-2 HMP – N1, N2 & RNase P Multiplex is a real-time reverse transcriptase, polymerase chain reaction (PCR) assay for use on the BD MAX™, Bio-Rad CFX96 Touch™ and Applied Biosystems QuantStudio™ 5 platforms for the qualitative detection of the presence of RNA from nucleocapsid phosphoprotein gene (N gene) of the SARS-CoV-2 coronavirus and the human RNase P gene. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for specific detection of SARS-CoV-2 by amplifying two unique regions of the N gene (i.e., N1 and N2). Detection of the human RNase P gene serves as an endogenous Sample Processing Control (SPC).
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400-060-G-MAX COVID-19, Flu A, Flu B, RSV - RT-PCR for BD MAX™
Target Organism: SARS-CoV-2 (N1), Influenza A, Influenza B, RSV A/B
IntendedUse: COVID-19, Flu A, Flu B, RSV – RT-PCR for BD MAX™ is a real-time reverse transcriptase, polymerase chain reaction (PCR) assay for use on the BD MAX™ platform for the qualitative detection of the presence of RNA from SARS-CoV-2 (N1; nucleocapsid phosphoprotein gene1,2,3), Influenza A (matrix gene), Influenza B (nonstructural gene), RSV A/RSV B (nucleoprotein gene).
Xfree™ Direct RT-PCR – Extraction-Free – Multi-platform
500-003-XMP COVID-19 Direct RT-PCR
Target Organism: Nucleocapsid Phosphoprotein N1
Intended Use: The BioGX Xfree™ COVID-19 Direct RT-PCR (“Xfree COVID-19”) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in nasopharyngeal and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. Within the United States, the BioGX Xfree COVID-19 kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab and oropharyngeal swab samples during the acute phase of infection.
The multiplex PCR assay is provided in BioGX Sample-Ready™ lyophilized format within a 2 mL vial. Each vial contains all PCR components such as primers, probes, enzymes, dNTPs, MgCl2, Internal Amplification Control RNA (IAC), and buffers required for real-time RT-PCR-based testing of 24 direct patient samples or 36 extracted/purified nucleic acid samples
STI & Women’s Health
400-003-C-MAX Mycoplasma-Ureaplasma - OSR BD MAX™
Target Organism: Mycoplasma genitalium (MgPa operon), Ureaplasma urealyticum (UUR10_0680), M. hominis (gap), U. parvum (UPA3_0062), and SPC
Intended Use: The BioGX Mycoplasma – Ureaplasma – OSR for BD MAX™ is a real time multiplex qualitative in vitro test reagent intended to be used by laboratory personnel trained in the use of the BD MAX™ automated real-time PCR system. The test is intended to aid in the diagnosis of Mycoplasma or Ureaplasma infection by detecting the presence of DNA from Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum extracted from samples collected in ThinPrep or universal transport media (UTM) from individuals at risk of infection.
Clinical Significance: Mycoplasma genitalium, Ureaplasma urealyticum, Mycoplasma hominis, and Ureaplasma parvum are small gram-negative bacteria that are sexually transmitted and considered to be either commensal or pathogenic. While there are decades of history studying these bacteria of the genital and urinary tracts, evidence points towards these bacteria playing dual roles in both the normal flora as well as contributing to chorioamnionitis, salpingitis, bacterial vaginosis, and postpartum endometritis.
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400-012-C-MAX Candida Speciation GATPK - OSR BD MAX™
Target Organism: Candida glabrata (ITS), C. albicans (ITS), C. tropicalis (ITS), C. parapsilosis (ITS), C. krusei (ITS), and SPC
Intended Use: The BioGX Candida Speciation GATPK – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Candida glabrata, Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and a DNA sample processing control (abbreviated as GATPK and SPC, respectively).
Clinical Significance: The BioGX Candida Speciation GATPK – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Candida glabrata, Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and a DNA sample processing control (abbreviated as GATPK and SPC, respectively).
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| Size | Download | |
|---|---|---|
| UDP_Report_400012CMAX S4 | 34.56 KB | DownloadPreview |
| ENGLISH VERSION - 400-012-C-MAX_Candida_Speciation_GATPK_BVPI_Rev06_22SEP2023 | 950.55 KB | DownloadPreview |
| 400012CMAX S4_v1 | 15.68 KB | Download |
400-027-C-MAX Lesion HSVHD - OSR BD MAX™
Target Organism: HSV-1 (US4/gG), HSV-2 (US6/gD), Haemophilus ducreyi (16S), SPC
Intended Use: The BioGX Lesion HSVHD – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from HSV-1, HSV-2, Haemophilus ducreyi, and a DNA sample processing control (abbreviated HSVHD and SPC, respectively). The assay is run on an automated DNA extraction and real-time PCR instrument with Copan ESwab™ or Copan universal transport media (UTM™) from lesion swab collections.
Clinical Significance: Infection with the herpes simplex virus, commonly known as herpes, can be due to either HSV-1 or HSV-2. HSV-1 is mainly transmitted by oral-to-oral contact and causes infection in or around the mouth whereas HSV-2 is almost exclusively sexually transmitted. Haemophilus ducreyi is the causative agent of chancroid and is generally sexually transmitted.HSV-1 and HSV-2 infections are among the most ubiquitous of human infections. An estimated 90% of all people worldwide will have been infected by one or both of the viruses during their lifetime. On the other hand, Haemophilus ducreyi is more rare and generally only observed regularly in areas where access to healthcare is limited. In these developing populations, Haemophilus ducreyi is the major cause of skin ulceration in children.
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400-035-C-MAX Candida-Trichomonas - OSR BD MAX™
Target Organism: Candida albicans (ITS), C. glabrata (ITS), C. krusei (ITS), Trichomonas vaginalis (repeated DNA target), SPC
Intended Use: The BioGX Candida-Trichomonas – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Candida albicans, Candida glabrata, Candida krusei, Trichomonas vaginalis, and a DNA sample processing control (SPC).
Clinical Significance: Candidiasis is a fungal infection caused by yeasts that belong to the genus Candida. Candida yeasts normally reside in the intestinal tract and can be found on mucous membranes and skin without causing infection; however, overgrowth of these organisms can cause symptoms to develop. While there are over 150 known species of Candida, only 15 of these are known to cause infections in humans. The most common species that cause infections are Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, and Candida krusei. The most predominant strain is Candida albicans which makes up 85-95% of yeast strains isolated from the vagina. Of the remainder of non-albicans isolates, the most common is Candida glabrata.
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| Title | Size | Download |
|---|---|---|
| UDP_Report_400035CMAX S4 | 34.35 KB | DownloadPreview |
| ENGLISH VERSION - 400-035-C-MAX_Candida-Trichomonas_BVPI_Rev05_22SEP2023 | 1.01 MB | DownloadPreview |
| 400035CMAX S4_v1 | 15.76 KB | Download |
400-038-C-MAX Syphilis - OSR BD MAX™
Target Organism: Treponema pallidum, SPC
Intended Use: The BioGX Syphilis – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Treponema pallidum, and a DNA sample processing control (abbreviated as SPC).
Clinical Significance: Syphilis is a systemic, sexually transmitted disease (STD) cause by the bacterium Treponema pallidum. Transmission can occur during sexual contact (vaginal, anal, or oral sex) through direct contact with syphilis sores or lesions, known as chancre. It is also possible to transmit infection vertically from an infected mother to her unborn baby.
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| Title | Size | Download |
|---|---|---|
| UDP_Report_400038CMAX S4 | 32.46 KB | DownloadPreview |
| ENGLISH VERSION - 400-038-C-MAX_Syphilis_BVPI_Rev04_22SEP2023 | 0.99 MB | DownloadPreview |
| 400038CMAX S4_v1 | 12.49 KB | Download |
Immunocompromised, Meningitis & Encephalitis
400-005-C-MAX Bacterial Meningitis NSH - OSR BD MAX™
Target Organism: Neisseria meningitidis (sodC), Streptococcus pneumoniae (ply), Haemophilus influenzae (hpd), SPC
Intended Use: The BioGX Bacterial Meningitis NSH – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and a DNA sample processing control (abbreviated NSH and SPC, respectively).
Clinical Significance: The majority of bacterial meningitis cases are caused by Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B Streptococcus, and Listeria monocytogenes. Incidence of bacterial meningitis is seen mostly in infants, of which roughly 80 cases per 100,000 people are seen annually in infants younger than 2 months as of 2007. Acute bacterial meningitis is very serious and can be deadly in an estimated 10-20% of cases. While most people with meningitis recover, permanent disabilities such as brain damage, hearing loss, and learning disabilities can result from the infection. In the United States, about 4,100 cases of bacterial meningitis including 500 deaths, occurred each year between 2003-2007.
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400-006-C-MAX Bacterial Meningitis ELGBS - OSR BD MAX™
Target Organism: E. coli (uidA), Listeria spp. (23S), Group B Streptococcus (sip), SPC
Intended Use: The BioGX Bacterial Meningitis ELGBS – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from E. coli, Listeria spp., Group B Streptococcus, and a DNA sample processing control (abbreviated ELGBS and SPC, respectively).
Clinical Significance: The majority of bacterial meningitis cases are caused by Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B Streptococcus, and Listeria monocytogenes. Incidence of bacterial meningitis is seen mostly in infants, of which roughly 80 cases per 100,000 people are seen annually in infants younger than 2 months as of 2007. Acute bacterial meningitis is very serious and can be deadly in an estimated 10-20% of cases. While most people with meningitis recover, permanent disabilities such as brain damage, hearing loss, and learning disabilities can result from the infection. In the United States, about 4,100 cases of bacterial meningitis including 500 deaths, occurred each year between 2003-2007.
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400-030-C-MAX EBV - OSR BD MAX™
Target Organism: Epstein-Barr Virus (balf5), SPC
Intended Use: The BioGX EBV – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Epstein-Barr Virus (EBV), and a DNA sample processing control (SPC). The assay is run on an automated DNA extraction and real-time PCR instrument with Urine, Serum, Plasma, or Cerebrospinal Fluid (CSF) from individuals at risk for presence of EBV. Automated extraction of the sample DNA is done using the BD MAX™ ExK™ DNA-1 series extraction kits. The extraction kits contain the SPC DNA so no external addition of SPC is required. The SPC serves as both an extraction control and an internal amplification control (IAC).
Clinical Significance: Epstein-Barr Virus (EBV), also known as human herpesvirus-4 is spread most often through bodily fluids, primarily saliva. Infection with EBV is the leading cause of mononucleosis, more commonly known as “kissing disease”. While over 90% of adults will be infected with EBV in their lifetime, most are infected in adolescence and young adulthood and do not produce any symptoms of mononucleosis such as fever, sore throat, and tiredness.
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400-057-C-MAX Viral Meningitis HSV/VZV - OSR BD MAX™
Target Organism: HSV-1 (US4/gG), HSV-2 (US6/gD), VZV (ORF71), SPC
Intended Use: The BioGX Viral Meningitis HSV/VZV – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2), Varicella-Zoster Virus (VZV), and a DNA sample processing control (SPC).
Clinical Significance: Infection with the herpes simplex virus, commonly known as herpes, can be due to either HSV-1 or HSV-2. HSV-1 is mainly transmitted by oral-to-oral contact to cause infection in or around the mouth whereas HSV-2 is almost exclusively sexually transmitted. Infection with VZV, the common cause of chickenpox, is highly contagious and can be transmitted via droplets, aerosol, or direct contact. Infection with HSV-1, HSV-2, and VZV is widespread throughout the world.
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Drug Resistance
400-007-C-MAX Vancomycin Resistance - OSR BD MAX™
Target Organism: vanA, vanB, vanC1, vanC2/3, SPC
Intended Use: The BioGX Vancomycin Resistance – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from vanA, vanB, vanC1, vanC2/3, and a DNA sample processing control (SPC).
Clinical Significance: Vancomycin resistant Enterococcus (VRE) are multi-drug resistant bacteria that contribute to hospital acquired infections through the widespread use of broad-spectrum antimicrobial drugs. Enterococci are resilient organisms that survive on fomites, the hands of health care workers and within the stool of colonized patients. VRE isolates expressing different resistance determinants have the following characteristic phenotypes:
- vanA – resistance to high concentrations of vancomycin and teicoplanin with minimum inhibitory concentrations of ≥64 μg/mL and ≥8 μg/mL, respectively.
- vanB – susceptibility to teicoplanin and resistance to vancomycin concentrations from 4 to >1024 μg/mL.
- vanC – intrinsically resistant to vancomycin and teicoplanin at ≤32 μg/mL and ≤1 μg/mL, respectively.
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400-015-C-MAX Carbapenem Resistance KNO - OSR BD MAX™
Target Organism: KPC, NDM-1, OXA-48, SPC
Intended Use: The BioGX Carbapenem Resistance KNO – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for qualitative real-time PCR multiplex detection of DNA from the blaKPC, blaNDM-1, and blaOXA-48 resistance genes, and a DNA sample processing control (abbreviated as KNO and SPC, respectively).
Clinical Significance: Carbapenemase Producing Enterobacteriaceae/Organisms (CPE/CPO, respectively) are bacteria that are difficult to treat because of multi-drug resistance that is associated with high mortality rates, often estimated at 40% or higher. Resistance to broad-spectrum carbapenem antibiotics stems from production of carbapenemases such as KPC, NDM, IMP, GES, VIM, and OXA-48. These enzymes are capable of breaking down almost all β-lactams, including the carbapenems, and rendering them ineffective. The majority of the genes encoding for carbapenemases are plasmid-mediated which allows for horizontal transmission among a variety of bacterial species and genera contributing to the aggressive spread of resistant organisms. Carbapenem is considered to be a “last-resort” antibiotic to treat multi-drug resistant infections.
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400-017-C-MAX Carbapenem/Colistin Resistance VGM - OSR BD MAX™
Target Organism: KPC, NDM-1, OXA-48, SPC
Intended Use: The BioGX Carbapenem/Colistin Resistance VGM – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for qualitative real-time PCR multiplex detection of DNA from the bla VIM ,bla GES , and mcr-1 resistance genes, and a DNA sample processing control (abbreviated as VGM and SPC, respectively).
Clinical Significance: Carbapenemase Producing Enterobacteriaceae/Organisms (CPE/CPO, respectively) are bacteria that are difficult to treat because of multi-drug resistance that is associated with high mortality rates, often estimated at 40% or higher. This resistance to broad-spectrum carbapenem antibiotics stems from production of carbapenemases such as KPC, NDM, IMP, GES, VIM, and OXA-48. These enzymes are capable of breaking down almost all β-lactams, including the carbapenems, and rendering them ineffective. The majority of the genes encoding for carbapenemases are plasmid-mediated which allows for horizontal transmission among a variety of bacterial species and genera contributing to the aggressive spread of resistant organisms. Plasmid mediated colistin resistance is encoded by the mobilized colistin resistance gene mcr. Both carbapenem and colistin are considered to be “last-resort” antibiotics to treat multi-drug resistant infections.
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| Size | Download | |
|---|---|---|
| UDP_Report_400017CMAX S4 | 33.92 KB | DownloadPreview |
| ENGLISH VERSION - 400-017-C-MAX_Carbapenem_Resistance_VGM_BVPI_Rev08_22SEP2023 | 1.05 MB | DownloadPreview |
| 400017CMAX S4_v1 | 16.10 KB | Download |
400-037-C-MAX vanA/B - OSR BD MAX™
Target Organism: vanA, vanB, SPC
Intended Use: The BioGX vanA/B – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from vanA, vanB, and a DNA sample processing control (SPC). The assay is run on an automated DNA extraction and real-time PCR instrument with rectal swabs (Copan ESwab™ or Copan FecalSwab™) from individuals at risk for presence of vancomycin resistant Enterococcus and organisms containing vancomycin resistance genes.
Clinical Significance: Vancomycin resistant Enterococcus (VRE) are multi-drug resistant bacteria that contribute to hospital acquired infections through the widespread use of broad-spectrum antimicrobial drugs. Enterococci are resilient organisms that survive on fomites, the hands of health care workers and within the stool of colonized patients. VRE isolates expressing different resistance determinants have the following characteristic phenotypes:
- vanA – resistance to high concentrations of vancomycin and teicoplanin with minimum inhibitory concentrations of ≥64 μg/mL and ≥8 μg/mL, respectively.
- vanB – susceptibility to teicoplanin and resistance to vancomycin concentrations from 4 to >1024 μg/mL.
- vanC – intrinsically resistant to vancomycin and teicoplanin at ≤32 μg/mL and ≤1 μg/mL, respectively.
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| Size | Download | |
|---|---|---|
| UDP_Report_400037CMAX S4 | 33.01 KB | DownloadPreview |
| ENGLISH VERSION - 400-037-C-MAX_vanA_B_BVPI_Rev05_22SEP2023 | 1.01 MB | DownloadPreview |
| 400037CMAX S4_v1 | 13.30 KB | Download |
Wound, UTI & Sepsis
400-028-C-MAX Urinary Tract EKEGA - OSR BD MAX™
Target Organism: E.coli (uidA), Klebsiella spp. (bdg and LacZ), Enterococcus faecalis (16S), Streptococcus pyogenes/GAS (speB), SPC
Intended Use: The BioGX Urinary Tract EKEGAS – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Escherichia coli, Klebsiella spp.,Enterococcus faecalis, Group A Streptococcus (EKEGAS), and a DNA sample processing control (SPC).
Clinical Significance: Urinary tract infections (UTIs) are among the most common infections in people, and antibiotic treatment is usually helpful in treating an infection. UTIs can affect several parts of the urinary tract, but the most common type of UTI is a bladder infection (also known as cystitis). Infection can sometimes spread to the kidneys (known as pyelonephritis).
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| Title | Size | Download |
|---|---|---|
| UDP_Report_400028CMAX S4 | 34.68 KB | DownloadPreview |
| ENGLISH VERSION - 400-028-C-MAX_Urinary_Tract_EKEGAS_BVPI_Rev06_22SEP2023 | 1.02 MB | DownloadPreview |
| 400028CMAX S4_v1 | 17.04 KB | Download |
Enteric Pathogens
400-009-C-MAX Parasitic Enteric CGED - OSR BD MAX™
Target Organism: Cryptosporidium parvum (DNAj-like protein gene), Giardia intestinalis (ssrRNA), Entamoeba histolytica (18S), Dientamoeba fragilis (5.8S), SPC
Intended Use: The BioGX Parasitic Enteric CGED – OSR for BD MAX™ is an automated in vitro diagnostic test reagent. The open system reagent (OSR) is used for the multiplex qualitative detection of DNA from Cryptosporidium parvum, Giardia intestinalis, Entamoeba histolytica, Dientamoeba fragilis, and a DNA sample processing control (abbreviated as CGED and SPC, respectively). The assay is run on an automated DNA extraction and real-time PCR instrument with Direct Stool, Copan ESwab™, or Copan FecalSwab™ from individuals at risk for presence of enteric parasites.
Clinical Significance: Cryptosporidium parvum, Giardia intestinalis, and Entamoeba histolytica are all parasites that can be contracted through direct contact with contaminated fecal matter or contaminated water. Symptoms of these enteric parasites generally include diarrhea, dehydration, and nausea but infection can also be asymptomatic.
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