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Complies with Medical Standard ISO 13485
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Instant Result Rapid Screening Test Kit for Syphilis. Results in <10 minutes.
Syphilis Overview
Syphilis is a common bacterial infection caused by Treponema pallidum. It is primarily spread through sexual contact and can progress in distinct stages if left untreated, leading to severe health complications. Many individuals may not realize they are infected, making routine screening essential for early detection and treatment. Syphilis infection rates are increasing in many countries.
1. What is Syphilis? Syphilis is a sexually transmitted bacterial infection that develops in stages (primary, secondary, latent, and tertiary). It can cause long-term complications if not treated early.
2. How is Syphilis Transmitted? Syphilis spreads through:
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Direct contact with syphilis sores during vaginal, anal, or oral sex. These sores may not be obvious to the party about to be infected.
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Transmission from an infected mother to her baby during pregnancy (congenital syphilis).
3. What are the Common Symptoms of Syphilis?
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Primary Stage: A painless sore (chancre) appears at the infection site.
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Secondary Stage: Skin rashes, swollen lymph nodes, fever, and fatigue.
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Latent Stage: No visible symptoms, but the infection remains.
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Tertiary Stage: Severe organ damage, including neurological and cardiovascular complications.
4. What are Possible Long-Term Complications?
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Neurological issues: Paralysis, dementia, vision loss.
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Cardiovascular complications: Damage to the heart and blood vessels.
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Increased risk of HIV infection.
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Congenital syphilis: Can be fatal to newborns.
5. How is an Infection Detected?
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Testing involves blood samples to detect syphilis antibodies. Rapid screening test kits for syphilis provide a fast and reliable option for early detection.
6. How is an Infection Treated?
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Antibiotics: Penicillin is the most effective treatment.
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Regular Follow-Up: Monitoring ensures the infection is fully cleared.
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Safe Practices: Avoid sexual contact until treatment is completed.
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Disclaimer
Informational Purposes Only: This website and the information it provides is intended for educational and informational purposes only. It is not represented as medical advise. Information about specific STDs has been gathered from trusted sources as is not the opinion of this site or its authors. It is not intended to replace medical advise or to substitute consulting a healthcare provider.
Preliminary Screening: Rapid test kits such as the products within this website are widely used in the field for preliminary screening purposes. They are not intended to diagnose or treat any medical condition. They should not be used as a substitute for professional medical evaluation. Whist highly accurate (see accuracy information) it is important to recognise that false negatives and false positive results are possible. Compared to a screening result, a diagnosis can only be provided by a medical healthcare provider upon analysis of all available information such as background, symptoms and test results.
About our Test Kits
QUALITY AND ACCURACY
The ISO 13485 Medical Device Standard
The screening kits we supply have been chosen for their quality and reliability in STD/STI screening. We supply kits that have a high rate of agreement compared to laboratory testing using ELISA or PCR methods. ELISA or PCR testing methods are carried out in a testing laboratory and are seen as reliable and accurate methods by which to compare another testing products performance. A very high agreement rate for a rapid STD/STI screening kit indicates a similar result to a gold standard laboratory test. A low agreement rate indicates a poor performance compared to a laboratory test and should not be considered a suitable product. Agreement rates vary slightly across the various STDs due to various factors but in general products have an agreement rate of between 95%-100%. The ISO and GMP manufacturing standards also ensure consistency of production quality. Some test such as Chlamydia test for the detection of an antigen, in this case a bacteria. Other test kits such as Hep B test for antibodies produced by the human immune system in response to infection. Each STD screening method relies on its own detection window period in order to function. It is important to understand the detection window period of each test you are taking to ensure that it complies with the test kit requirements. Disclaimer: Rapid test kits are designed as a primary screening solution and all results should be consulted with your health professional. It is important to read and follow the instructions carefully.
ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. Certification to ISO 13485 requires its quality system to pass a third-party Medical Device Single Audit Program, or “MDSAP” audit. ISO 13485 is recognized by WHO.
You can read more about ISO 13485 here https://en.wikipedia.org/wiki/ISO_13485
What ISO 13485 means to the consumer:
Consumers can purchase products carrying the ISO 13485 standard knowing that the design and manufacturing process is legally compliant and meets quality management assurance. Additionally, the manufacturing plant is inspected annually by ISO staff.
