Vivalytic | C. Difficile
Vivalytic | C. difficile
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Detection of Clostridioides difficile (C. difficile)
Qualitative RT-PCR detection of C. difficile
- Quick turnaround time of less than 50 minutes, beneficial for both the patient and for the containment of C.difficile
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
- Detection from liquid or soft human stool specimens
Clinical Significance
Gastroenteritis refers to the inflammation of the stomach, small intestine, and large intestine. The primary cause of acute gastrointestinal illnesses (AGI) is viral infections, particularly Norovirus and Rotavirus, while bacterial pathogens like Clostridioides difficile (C. difficile) can also be responsible. C. difficile is an anaerobic bacterium found widely in soil and the intestinal tracts of animals. The clinical spectrum of C. difficile infection (CDI) varies from mild diarrhoea to severe and life-threatening pseudomembranous colitis. Transmission mainly occurs within healthcare settings such as hospitals, through patient-to-patient contact, contaminated hands of healthcare workers, or environmental contamination.
The Vivalytic C. difficile panel is specifically designed to detect the presence of Clostridioides difficile toxin genes tcdA and tcdB from liquid or soft human stool samples to enhance healthcare practices. With its advanced capabilities, this diagnostic tool empowers healthcare providers in their efforts to combat C. difficile infections, contributing to more effective management of this challenging condition.
Features
Sample Type: Swab samples from liquid or soft human stool specimens
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: Less than 50 minutes
| Detectable Pathogens | ||
|---|---|---|
| C. difficile (toxin genes tcdA/tcdB) | ||
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Vivalytic | Bordetella
Vivalytic | Bordetella
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Detection of B. pertussis, B. parapertussis, B. holmesii
Qualitative RT-PCR detection of Bordetella Species
- Quick turnaround time of 47 minutes, beneficial for both the patient and for the containment of Bordetella reducing aerogenic transmission.
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings.
- Real-time PCR enables rapid and targeted detection up to 4 weeks after the onset of symptoms and differentiate the human pathogenic Bordetella species.
Clinical Significance
Bordetella pertussis, a gram-negative bacterium, is responsible for the respiratory infection known as pertussis or whooping cough. Other related bacteria such as Bordetella bronchiseptica, Bordetella holmesii, and Bordetella parapertussis can also cause whooping cough or mild symptoms. The transmission of Bordetella infections occurs through droplet infection. Several laboratory diagnostic methods are available, including real-time PCR, culture, and serology. Real-time PCR enables fast and accurate detection of the bacteria up to four weeks after the onset of symptoms, offering sensitivity and specificity.
With the Vivalytic Bordetella test identification of these bacterial strains becomes more accessible, aiding in the prompt initiation of appropriate treatment. This state-of-the-art diagnostic tool enhances the overall efficiency of healthcare practices and contributes to improved patient outcomes with reduced risk of infection for the user.
Features
Sample Type: Nasopharyngeal swab sample
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: 47 minutes
| Detectable Pathogens | ||
|---|---|---|
| B. pertussis | B. parapertussis | B. Holmesii |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Vivalytic | Monkeypox (MPXV)
Vivalytic | MPXV
–
Detection of Monkeypox Virus and non-variola Orthopoxvirus species.
*Research Use Only
RT-PCR detection of Monkeypox Virus and non-variola Orthopoxvirus species.
- Quick turnaround time of 45 minutes, beneficial for both the patient and for the containment of Monkeypox
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
- Two target approach: Detection of MPXV and Orthopoxvirus species (including MPXV)
Clinical Significance
Vivalytic Monkeypox virus (MPXV) is a rapid and user-friendly test designed to aid the global response against Monkeypox. Monkeypox is a zoonotic virus belonging to the Orthopoxvirus subset genus within the Poxviridae family. It spreads between species through animal bites and the transfer of bodily fluids. Human-to-human transmission can occur through contact with infected lesions, inhalation of respiratory droplets, and indirect exposure to contaminated objects. Sexual contact is recognised as a significant mode of transmission during outbreaks of infection.
The Vivalytic MPXV Panel is specifically developed to detect the presence of the Monkeypox virus and non-variola orthopoxvirus species. With a remarkable time-to-result of just 45 minutes, this cutting-edge test offers swift and accurate screening of these viral pathogens, improving outbreak containment and prevention.
Features
Sample Type: Swab
Sample Volume: 300μL
Detection Method: Real-Time PCR
Time to result: 45 minutes
| Detectable Pathogens | |
|---|---|
| Monkeypox Virus (Clade I, Clade II) | Non-variola Orthopoxvirus species (Coqpox Virus, Ectromelia Virus, Monkeypox Virus, Taterapox Virus, Vaccinia Virus) |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Sexually Transmitted Infections ā Rapid Testing at the Point of Care
Urgency, Challenges and Advances in STI Testing
Sexually transmitted infections (STIs) are a major global health issue, with over 30 pathogens causing an estimated one million infections daily, a number that is rising. Surveillance programs in countries like the United States and Canada have reported an increase in STIs such as syphilis, gonorrhoea, and chlamydia. STIs can have serious consequences for sexual health, including infertility and chronic pelvic pain, particularly affecting women. The World Health Organization (WHO) has recognised the urgency of addressing this problem and has recommended measures to end the STI healthcare issue by 2030. Integrated testing, including multiplex and point-of-care testing, is considered essential. However, implementation of these recommendations at regional and national levels is lacking. Rapid point-of-care PCR tests that can detect multiple pathogens simultaneously would greatly improve STI diagnosis and containment. Currently, Randox, in collaboration with Bosch offers two STI test panels on the Vivalytic POC system: Vivalytic STI and Vivalytic MG, MH, UP/UU panels, capable of detecting multiple pathogens in a single test run, with results available within hours.
The Global Burden
- The WHO estimates 374 million new infections of chlamydia, gonorrhoea, syphilis, and trichomoniasis annually.
- Chlamydia is the most frequently reported STI in Europe, followed by gonorrhoea and syphilis.
- Countries with comprehensive STI screening programs, like Denmark, have higher prevalence rates than the European average.
- The UK has a comprehensive screening program for chlamydia targeting 15-24-year-olds, with cases accounting for 60% of total cases in the European Region.
- The actual infection rate in countries without systematic screening is likely higher than official figures suggest.
- Reported cases of gonorrhoea and syphilis in the European Region have increased, particularly among certain age groups and higher numbers in men than women.
Gaps in Current STI Testing Strategies
The European Centre for Disease Prevention (ECDC) acknowledges the growing concern of STIs in Europe and emphasises the importance of testing in their recent report. While various European countries have screening programs for chlamydia, testing options for other STI pathogens are usually limited. The lack of accessible testing, combined with the prevalence of asymptomatic infections, increases the risk of STI transmission and hampers containment efforts. Prevention campaigns and low-threshold testing opportunities are crucial to address the spread of STIs. The UK’s chlamydia screening program, implemented in 2008, demonstrated the benefits of community-based testing services and led to a significant increase in diagnosed cases, reducing the number of unreported cases.
Infections and Co-Infections
- Co-infections, where multiple sexually transmitted pathogens are present simultaneously, are common but often go undetected due to limited testing.
- Symptoms of co-infections can be difficult to differentiate since different pathogens can cause similar or overlapping symptoms.
- However, most STIs, even in high-risk groups, are caused by a single sexually transmitted pathogen.
- In cases where co-infections need to be detected, a rapid and comprehensive differential diagnosis of sexually transmitted pathogens is crucial for initiating appropriate therapy promptly.
The Importance of Rapid Results at the Point of Care
- Rapid detection and treatment of STIs are crucial to prevent further spread.
- Traditional STI diagnostics in specialized laboratories can result in delays of several days or up to 1-2 weeks until test results are available to the physician.
- Delays occur due to transportation of samples, laboratory workflow, result transfer, and scheduling additional appointments.
- The delay in treatment initiation can lead to decreased patient compliance and missed appointments.
The Vivalytic STI test provides results directly at the point of care (POC) in less than two and a half hours. It eliminates the need for sample transportation to a central laboratory. In addition, patients can receive their test results on the same day of the visit, allowing for immediate initiation of appropriate treatment.
In a Nutshell
Sexually transmitted infections (STIs) spread due to various factors. Many STIs do not show symptoms, resulting in numerous unreported and untreated cases that can have fatal consequences depending on the specific pathogen. Increasing awareness and implementing a decentralised low-threshold testing strategy can significantly reduce infections, particularly among high-risk groups. Speed and comprehensive testing of relevant pathogens are crucial for targeted therapy and containing STIs. Rapid PCR tests used at the point of care (POC) are emerging as important technologies due to their advantages. Patients receive same-day results and immediate treatment, providing clarity in just one visit. Clinicians can provide up-to-date diagnoses and treatments, even in decentralised or hospital settings, benefiting high-risk patients with limited access to healthcare.
Vivalytic
The Bosch Vivalytic, is an advanced and automated platform for molecular diagnostics that utilises PCR to detect pathogens. It offers applications for various medical disciplines and requires only a few steps from sample collection to obtaining results. The patient sample is processed automatically within the Vivalytic analyser, and the test result is displayed on its integrated screen. The time it takes to get results depends on the specific Vivalytic application. For the STI Panel, which simultaneously detects 10 common sexually transmitted pathogens, the time to result is 2.5 hours. On the other hand, the Vivalytic MG, MH, UP/UU panel, used to detect mycoplasmas and/or ureaplasmas, provides results in approximately one hour.
By conducting fully automated analyses at the point of care, Vivalytic saves valuable time for hospitals, labs, genitourinary clinics and doctor’s offices during their routine processes.
| STI Panel | MG, MH, UP, UU Panel |
|---|---|
| Chlamydia trachomatis | Mycoplasma genitalium |
| Neisseria gonorrhoeae | Mycoplasma hominis |
| Trichomonas vaginalis | Ureaplasma parvum/Ureaplasma |
| Mycoplasma genitalium | |
| Treponema pallidum | |
| Mycoplasma hominis | |
| Ureaplasma urealyticum | |
| Haemophilus ducreyi | |
| Herpes simplex virus I | |
| Herpes simplex virus II |
At a Glance
- The Vivalytic system allows fully automated sample analysis with minimal manual steps.
- It eliminates the need for expensive and complex laboratory equipment.
- Vivalytic supports both single and multiplex tests.
- The Vivalytic does not require peripheral equipment such as a laptop, keyboard, barcode scanner, or charging station.
- The cartridge used in the system ensures hygienic and safe operation as a closed system.
- Cartridges can be stored and used at room temperature.
- Vivasuite, a cloud-based solution, facilitates convenient device management.
- The Vivalytic can be seamlessly integrated into existing IT structures using HL7, Ethernet, USB, or WLAN.
For more information please contact us at: marketing@randox.com
Welcome to Vivasuite!
Running within the Bosch IoT cloud maintaining the highest standard of IT security and data privacy. Connectivity ensures that devices are always available and fully updated.
Advantages of Vivasuite:
– Schedule remote software updates
– Know when your devices were last synchronised
– View all devices in one dashboard
– View device information and general device data
– View testing history from one system
– Mobile device monitoring
– Vivalytic user management
– Save time with less “on-device” work
Vivalytic Overview
Discover more about the Vivalytic
Vivalytic | SARS-CoV-2 Dual Target, Flu A/B and RSV
Vivalytic | SARS-CoV-2 Dual Target, Influenza A/B and RSV
–
Rapid differentiation between SARS-CoV-2, Flu A/B, and RSV
SARS-CoV-2 Dual Target, Influenza A/B and RSV Rapid Test
- Detection from real-time PCR via Nasopharyngeal and/or Oropharyngeal swab
- Targets the E gene and N gene sequences for COVID-19 detection, as well as Influenza A and Influenza B and human Respiratory Syncytial Virus
- The SARS-CoV-2 DT, Flu A/B and RSV rapid test has recently received CE marking
- Simple and easy to use analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
- Rapid turnaround time of 53 minutes from sample entry to result
- Convenient 4 step process from sample entry to results. No laboratory training required
Clinical Significance
Patients afflicted with SARS-CoV-2, Influenza A (Flu A), Influenza B (Flu B), and/or Respiratory Syncytial Virus (RSV) often exhibit similar symptoms, yet necessitate distinct approaches to management. The SARS-CoV-2, Flu A/B, and RSV qualitative test streamlines the rapid triage and patient management process, swiftly identifying various viruses in under 1 hour.
This panel enables healthcare professionals to administer pathogen-specific treatments and targeted interventions effectively. By combining these tests, healthcare facilities not only streamline costs but also address the complexities of respiratory infections directly at the point of care. This integrated approach facilitates infection control measures and enhances risk assessment, ultimately contributing to more efficient and tailored patient care.
Features
Sample Type: Nasopharyngeal or Oropharyngeal Swab (eNAT)
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: 53 minutes
| Detectable Pathogens |
|---|
| SARS-CoV-2 (E gene) |
| Influenza A and Influenza B |
| Human Respiratory Syncytial Virus |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Rapid MG, MH, UP/UU Testing Now Available on Vivalytic
Introducing MG, MH, UP/UU Testing to Vivalytic
Aiding the rapid diagnosis of sexually transmitted infections (STIs) and immediate decision making at the point of care, the Vivalytic portfolio of tests has now expanded to complement current comprehensive screening for STI’s, introducing rapid screening for Mycoplasma genitalium (MG), Mycoplasma hominis (MH) & Ureaplasma parvum (UP)/urealyticum (UU) in 1 hour.
What are MG, MH, UP/UU pathogens?
According to the World Health Organization (WHO), over 30 different bacterial species, viruses and parasites have been identified to be involved in the spread of STIs. Mycoplasmas in particular belong to the group of human pathogenic bacterial species with many risk associations particularly on the female reproductive system.1 Studies have also found that UU and MH are implicated in prematurity-linked conditions 2. UP & UU bacterium again are implicated to have adverse implications for both men & women. They affect up to 70% of sexually active couples and exist mostly in an asymptomatic state. If left untreated, UP & UU may be associated with infertility and other risk associations such as meningitis and pneumonia. 3
Why test MG, MH, UP/UU on Vivalytic?
Current diagnostic cultivation methods for screening can take up to three days for MH, UP and UU or even 6 months, with the introduction of these STI pathogens to the Vivalytic, quick, accurate diagnosis and immediate treatment decisions can be made at the point of care , before symptoms worsen, or any long-term implications occurs to the patient. In a world where over 1 million STIs are acquired daily 5, a quick and efficient process that allows for almost immediate results can improve operations considerably.
The push to encourage individuals to test themselves regularly before engaging in sexual activities with a new partner is becoming more and more widespread. The Vivalytic, as a portable point of care device, designed to suit a range of environments such as Doctors’ offices or GUM/ Sexual Health Clinic, can provide a screening immediately, minimising the stress and uncertainty a patient may experience whilst waiting for a result to receive the relevant treatments if needed. The Vivalytic’s speed not only provides reliable and precise diagnoses, but also plays a role in fighting the spread of STIs and minimising hospitalisations that may arise from complications from undetected sexually transmitted pathogens.
Features and Benefits
- By using a single cartridge, the Vivalytic MG, MH, UP/UU test detects and differentiates between pathogens of the Mycoplasmataceae family
- Detection Method: Real-Time PCR
- Result Time: 1 hour
- Sample Volume: 300μl Clinical Sample
- Sample Type: Swab (Urethral, Vaginal, Cervical, Rectal), Urine
| DETECTABLE PATHOGENS |
|
What makes this possible?
Making this happen, The MG, MH, UP/UU rapid test on Vivalytic by Bosch, a point of care platform brought to the market by Randox Laboratories. The Vivalytic system is a fully automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex infectious disease testing. Each easy-to-use cartridge contains all necessary reagents, is fully sealed to minimise risk and can be conveniently stored at room temperature.
Making a point to care, the Vivalytic also provides a comprehensive sexual health profile of 10 bacterial, viral, and protozoan infections with a rapid turnaround time of just 2 hours from sample entry to result. Designed to offer a complete sexual health profile with an aim of prevention and control, the Vivalytic STI array can be used to diagnose existing infections whilst any identifying co-infections.
The Vivalytic consolidates the full molecular workflow into a small benchtop platform, capable of extraction, PCR amplification and detection. It follows an easy 4 step process from sample entry to results and with the gold standard PCR testing. With most up to date technology, the Vivalytic has wireless connectivity, with no peripherals required, making a unique space saving and hygienic solution. Handling and utilisation are simple and medical professionals require only minimal training.
For more information on the Vivalytic, why not visit our webpage: https://www.randox.com/vivalytic-molecular-point-of-care/
For more information on our new MG, MH, UP/UU test, please contact market@randox.com
References:
- Mardh P. A., Westrom L., von Mecklenburg C., Hammar E. Studies on ciliated epithelia of the human genital tract. I. Swelling of the cilia of Fallopian tube epithelium in organ cultures infected with Mycoplasma hominis. The British Journal of Venereal Diseases. 1976;52(1):52–57.
- Viscardi R. M. Ureaplasmaspecies: role in neonatal morbidities and outcomes. Archives of Disease in Childhood: Fetal and Neonatal Edition. 2014;99(1):F87–F92.
- World Health Organization. “Sexually Transmitted Infections (STIs).” int, World Health Organization: WHO, 22 Nov. 2021, www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis).
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Vivalytic Cartridges Hub
Vivalytic | Testing Menu
–
Making a Point to Care
Vivalytic Cartridge Hub
Respiratory Panels
SARS- CoV-2 Rapid
SARS-CoV-2 Dual Target
SARS-CoV-2 Pooling
SARS-CoV-2 Dual Target, Flu A/B and RSV
Viral Respiratory Infection (VRI)
Monkeypox (MPXV)
Bordetella
Coming Soon
Respiratory Tract Infection (RTI)
Respiratory Tract Infection (RTI) Chronic Lung Disease (CLD)
Chronic Lung Disease (CLD)
Genitourinary Panels
Hospital Acquired Infection Panels
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Vivalytic Testing Cartridges
VRI Array
Vivalytic
SARS-CoV-2 Rapid Test
Vivalytic | MG, MH, UP/UU Rapid Test
Vivalytic | MG, MH, UP/UU Rapid Test
–
Detection of Mycoplasma genitalium, Mycoplasma hominis & Ureaplasma parvum/urealyticum
RT-PCR detection of common STI pathogenic bacterial species
- Quick turnaround time of 53 minutes, beneficial for both the patient and for the containment of STIs
- Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
- Detection from a wide range of sample types including urine, urethral, vaginal, cervical and rectal swabs
Clinical Significance
Aiding in the diagnosis and containment of sexually transmitted infections (STIs) of symptomatic and asymptomatic individuals, the Vivalytic portfolio of tests has now expanded to complement current comprehensive screening.
The Mycoplasma genitalium (MG), Mycoplasma hominis (MH) & Ureaplasma parvum (UP)/urealyticum (UU) test guides appropriate treatment decisions at the earliest opportunity for improved patient management, prevention of transmission and supporting emerging macrolide resistance. MG, MH, UP/UU belong to the group of human pathogenic bacterial species associated with STIs even though particularly Ureaplasma ssp. are primarily considered as commensal organisms.
All four bacterial species can be detected simultaneously with the Vivalytic MG, MH, UP/UU test cartridge.
* Detailed information on the determination of analytical performance can be found in instructions for use provided with the testing kit.
Features
Sample Type: Swab (Urethral, Vaginal, Cervical, Rectal), Urine
Sample Volume: 300 μl
Detection Method: Real-Time PCR
Time to result: 53 minutes
| Detectable Bacteria |
|---|
| Mycoplasma genitalium |
| Mycoplasma hominis |
| Ureaplasma parvum/urealyticum |
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Vivalytic Workflow
Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.
To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.
The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products