Rapid MG, MH, UP/UU Testing Now Available on Vivalytic
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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Making a Point to Care
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Respiratory
SARS-CoV-2 Dual Target, Flu A/B and RSV
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SARS- CoV-2 Rapid 39 minutes Test
Respiratory Tract Infection (RTI) *Planned
Respiratory Tract Infection (RTI) *PlannedSARS-CoV-2 Dual Target
Chronic Lung (CLD) *Planned
Chronic Lung (CLD) *Planned
Genitourinary
Sexually Transmitted Infection (STI)
MG, MH, UP/UU Rapid Test
Urinary Tract Infection (UTI) *In Development
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Vivalytic | MG, MH, UP/UU Rapid Test
Vivalytic | MG, MH, UP/UU Rapid Test
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Detection of Mycoplasma genitalium, Mycoplasma hominis & Ureaplasma parvum/ urealyticum
RT-PCR detection of common STI pathogenic bacterial species
- Quick turnaround time of 1 hour, 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
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.
*Detail information on the determination of analytical performance can be found in instructions for use provided with the testing kit.
| Detectable Bacteria |
|---|
| Mycoplasma genitalium |
| Mycoplasma hominis |
| Ureaplasma parvum/urealyticum |
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.
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
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Vivalytic | MRSA & MSSA Rapid Test
Vivalytic | MRSA/MSSA Rapid Test
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Rapid differentiation between MRSA & MSSA in 53 minutes
Bacterial Differentiation to Promote Targeted Therapy
- Improves patient pathways and the need for care with screening at both ward level, emergency settings and before elective surgery procedures identifying suspected sensitive or resistant bacterial staphylococcus strains.
- Speed is key – 53 minutes for results vs 1-3 days for culture sampling
- MRSA/SA screening contributes to current health risks by preventing contamination, breaking the chain of infection, and fighting against antimicrobial resistance and superbugs.
MRSA/SA is a qualitative RT-PCR test detecting and differentiating between methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive Staphylococcus aureus (MSSA) and methicillin-resistant coagulase-negative Staphylococci (MRCoNS). By using one single cartridge, the Vivalytic MRSA/SA test aids in the diagnosis of MRSA infection in a speedy manner so that appropriate antibiotic treatment can be applied, and complications prevented.
| Detectable Pathogens | Specific Gene Targets |
|---|---|
| Methicillin-resistant Staphylococcus aureus (MRSA) | SCCmec/orfX junction, mecA/ mecC, SA422 |
| Methicillin-sensitive Staphylococcus aureus (MSSA) |
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.
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
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Vivalytic Test Menu
Vivalytic | SARS-CoV-2 Rapid Dual Target
Vivalytic | SARS-CoV-2 Dual Target Rapid Test
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Detecting E & N gene sequence for SARS-CoV-2
SARS-CoV-2 Dual Target Detection
- Detection from real-time PCR via Nasopharyngeal and/Oropharyngeal swab or lollipop swab collection
- The SARS-CoV-2 rapid test targets the E gene & N gene sequence for COVID-19 detection
- The SARS-CoV-2 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 just 30 – 49 minutes from sample entry to result*
- Convenient 4 step process from sample entry to results. No laboratory training required
SARS-CoV-2 dual target is a rapid real time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care. This enables the patient to take the recommended safety precautions without delay.
The SARS-CoV-2 dual target rapid test allows for detection of both the E-gene and N-gene sequence for SARS-CoV-2 with minimal workflow required, suitable for laboratory and non-laboratory settings. The SARS-CoV-2 dual target test also contains a Human and Internal PCR control for convenience.
In collaboration with Bosch, we are proud to release not only a rapid testing solution for the detection of SARS-CoV-2 but an accelerated mass testing solution to effectively and efficiently monitor and detect viral infection from the offset with an aim of minimising the rise in infections globally. The new SARS-CoV-2 pooling test will allow users to test up to 160 samples a day and has sensitivity of 98% and a specificity of 100% – a world’s first!*
*Detail information on the determination of analytical performance can be found in instructions for use provided with SARS-CoV-2 kit.
*Test Termination: If one of the target genes is clearly detected, the test can be terminated prematurely with the valid positive result.
Vivalytic Workflow
| Detectable Virus |
|---|
| SARS-CoV-2 (E-gene and N-gene sequence) |
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.
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
Related Products
Viral Respiratory Infection Array
SARS-CoV-2 Pooling Test
Vivalytic
Vivalytic Test Menu
Rapid PCR MRSA/SA testing now available on Vivalytic
Rapid PCR MRSA/SA testing now available on Vivalytic
Providing a quick diagnosis of methicillin resistant at the point of the care, the latest addition to the Vivalytic portfolio of tests, not only provides rapid RT-PCR results in 53 minutes but differentiates whether the bacterial strain is methicillin-resistant (MRSA) or methicillin-sensitive (MSAA) which promotes targeted therapy.
MRSA is a major multi-resistant nosocomial pathogen worldwide with the WHO estimating that the mortality rate of patient infection rates is around 50% higher compared with patients who have been infected by non-resistant Staphylococcus aureus strains.1 Moreover, the extensive period of hospitalisation, morbidity, and the associated medical costs increase significantly with an MRSA infection.2
Introducing MRSA to the vivalytic portfolio can provide high quality answers, anywhere and anytime improving patient pathways and the need for care. Significantly, introducing rapid MRSA screening at both ward level, emergency settings and before hospital elective surgery procedures allow for an effective response to identifying whether the bacteria strain is methicillin-sensitive (MSSA) or -resistant.
Making a point to care, the rapid essence and speed of Vivalytic not only showcase technology but the ability to contribute to current health risks by preventing contamination, breaking the chain of infection, and again fighting the silent pandemic of antimicrobial resistance (AMR) & superbugs.
The treatment on the front line today looks at increasing empirical antibiotic prescribing and increasing drug-resistant outbreaks. AMR is growing rapidly, with superbugs threatening the ability to treat common infectious diseases appropriately. The COVID-19 pandemic has elevated concerns over AMR and antibiotic-associated adverse events, with surges in antibiotic prescribing, hospitalisations, and drug-resistant bacterial transmissions.
Speed is key here – since the result of diagnostics with culture sampling, which is the current traditional method for MRSA testing is only available after one to three days, this PCR test for the point of care is ideal as an additional tool when speed is of the essence.
Few points to note about the current Vivalytic panel for MRSA/SA detection:
- By using one single cartridge, the Vivalytic MRSA/SA test detects and differentiates between MRSA and MSSA DNA to aid in the diagnosis of MRSA infection in a speedy manner so that appropriate antibiotic treatment can be applied, and complications prevented.
- Detection Method: Real-Time PCR
- Result Time: 53 minutes
- Sample Volume: 600 μl
- Sample Type: Nasal- or oropharyngeal swab sample
| DETECTABLE DNA PATHOGENS: | SPECIFIC GENE TARGETS: |
|---|---|
| Methicillin-resistant Staphylococcus aureus (MRSA) | SCCmec/orfX junction |
| Methicillin-sensitive Staphylococcus aureus (MSSA) | mecA/ mecC, SA422 |
Making this happen, The MRSA/SA 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.
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 MRSA test, please contact market@randox.com
ABOUT RANDOX
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National STIQ Day 2022
National STIQ Day 2022
14th January, National STIQ day was launched to get people thinking about the importance of sexual health and encourage everyone to get regular health checks.
More than 30 different bacteria, viruses and parasites are known to be transmitted through sexual contact. Eight of these pathogens are linked to the greatest incidence of sexually transmitted diseases (STI’s). STI’s are spread predominantly by sexual contact, including vaginal, anal and oral sex. Some STI’s can also be transmitted from mother-to-child during pregnancy, childbirth, and breastfeeding.
Any individual can catch an STI regardless of what age they are, their sexuality or how many sexual partners they have, as it only takes one sexual encounter to increase the risk of catching an infection. The importance of regular STI testing allows individuals to get peace of mind and take control of their sexual health as many infections don’t present symptoms and it’s advised that testing is required if individuals are concerned about their health, present symptoms or change sexual partner. Regular screening can aid in detecting an infection in the early stages and help to reduce the risk of such complications.
The increase in STI’s underline the need for urgent action which many reports have highlighted the need of ongoing inaction and development of strategies to improve sexual health. It has been widely noted by the CDC that over 20 million new STI’s are detected each year. (1) Public Health England also reported that 468,342 diagnoses of STIs had been reported in England in 2019 – a 5% increase from 2018 with a 26% increase in gonorrhoea infections, 10% increase in syphilis and 7% increase in the number of consultations at national sexual health services. It’s also widely noted that chlamydia testing, which is most common in young adults has declined by 13% since 2015 and 2% of all individuals tested had received a positive diagnosis. (2) (3)
Here at Randox, we offer solutions for clinical laboratories, point of care testing solutions and home STI testing kits for convenience and discretion. Randox provides the broadest STI testing menu on the market. Detecting 10 bacterial, viral, and protozoan infections, the STI test provides a comprehensive sexual health profile. The CE-marked STI Array provides the identification of co-infections, often in asymptomatic individuals and enable antibiotic stewardship.
The Randox test presents excellent precision, specificity, sensitivity and accuracy for STI diagnoses, which reduces the risk of false reporting and unnecessary confirmatory tests. The Randox simultaneous multiplex test means smaller sample volumes are required, enabling faster throughput and rapid patient diagnosis saving time and money for clinical and laboratories.
The Randox STI Multiplex test detects the following infections:
- Chlamydia trachomatis (CT)
- Neisseria gonorrhoeae (NG)
- Trichomonas vaginalis (TV)
- Mycoplasma genitalium (MG)
- Treponema pallidum (Syphilis) (TP)
- Herpes simplex virus 1 (HSV-1)
- Herpes simplex virus 2 (HSV-2)
- Haemophilus ducreyi (HD)
- Mycoplasma hominis (MH)
- Ureaplasma urealyticum (UU)
Does your laboratory or clinic carry out STI testing? Our molecular analyser, the Bosch Vivalytic and Evidence Investigator, powered by patented Biochip Array Technology, could be the diagnostic solution you need!
Solutions for the Laboratory
54 SAMPLES ● 1 TEST ● 10 INFECTIONS
The Evidence Investigator is a compact semi-automated benchtop analyser ideal for medium throughput laboratories.
- Sample Type: Swab or Urine
- Sample Volume: 300 μl
- Detection Method: Randox Biochip Technology (end-point PCR)
- Time to Result: 5 hours 30 minutes
STI Testing at the Point of Care
1 SAMPLE ● 1 TEST ● 10 INFECTIONS
The Bosch Vivalytic enables sample to answer, cartridge based molecular diagnostics at
the point of care. Powered by Randox Biochip Technology.
- Sample Type: Swab or Urine
- Sample Volume: 300 μl
- Detection Method: Randox Biochip Technology (end-point PCR)
- Time to Result: 2 hours 30 minutes
For more information about our STI Arrays or Vivalytic email: marketing@randox.com
- https://www.cdc.gov/std/life-stages-populations/adolescents-youngadults.htm
- https://www.tht.org.uk/news/rise-stis-underlines-need-urgent-action
- Sexually transmitted infections (STIs) (who.int)
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Vivalytic | Extensive SARS-CoV-2 Pooling
Vivalytic | Extensive SARS-CoV-2 Pooling Test
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15 Samples, 1 Cartridge
Simultaneous SARS-CoV-2 detection from up to 15 pooled samples
- Detection from real-time PCR using saliva lollipop swab collection.
- Up to 15 patient samples may be pooled and added to a single cartridge targeting the E gene sequence
- The SARS-CoV-2 pooling test has recently received CE marking.
- Simple and easy to use POC analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
- Rapid turnaround time of less than 45 minutes for results.
- Convenient 4 step process from sample entry to results. No laboratory training required
Extensive SARS-CoV-2 Pooling is a rapid real-time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care on the Vivalytic. The SARS-CoV-2 polling test with lollipop swab allows for the screening of up to 15 patient samples. One of the first rapid pooling PCR tests on the market, the Vivalytic produces results in less than 45 minutes delivering high accuracy for extensive and faster testing ideal for rapid and confirmatory SARS-CoV-2 screening in any environment.
Ideal for mass testing, the pooling could be done at the level of a ward, medical speciality, social bubble, or group of colleagues. It has potential for use in other settings, such as pre-operative screening, schools and universities, prisons, nursing homes, primary care, and large workplaces. Sample pooling allows more people to be tested quickly using fewer testing resources.
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.
“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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Viral Respiratory Infection Array
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Vivalytic Test Menu
SARS-CoV-2 Vascular & Multi-System Dysfunction Whitepaper
30 June 2021
SARS-CoV-2 Vascular & Multi-System Dysfunction Whitepaper Download
COVID-19, the disease caused by SARS-CoV-2, is an infectious disease caused by a newly discovered coronavirus. While many of whom become infected by the disease will experience mild to moderate cold or flu-like symptoms, those with health complications – such as autoimmune diseases, asthma, heart disease and diabetes – are at risk of developing serious illness and adverse outcomes.
As of September 2021, over 228 million COVID-19 cases have been confirmed worldwide, with an estimated one in six patients experiencing complications which could be life threatening, with over £116 billion spent by the UK government alone on measures to combat the disease. This drastic spending has been mirrored across the globe, with the significant economic burden expected to be suffered for generations to come.
The whitepaper provides a brief overview of the COVID-19 pandemic, before discussing vascular abnormalities and associated complications brought on by the virus, such as multi-system disfunction, acute respiratory disease syndrome (ARDS) and hepatic, renal & cardiovascular function.
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Vivalytic | Customer Support
Vivalytic | Customer Support
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Molecular Diagnostics at the Point of Care
VIDEO TUTORIALS
For your support, we have compiled a series of informative video tutorials on how to install and operate the Vivalytic machine. You can use these guides to refresh your knowledge from prior training or to learn about specific procedures step by step.
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