*Packaging color may differ according to distribution region.

Syphilis Test Kit

AccuQuik™ Diagnostic Detection

A Syphilis Test Kit is a rapid diagnostic tool used to screen for the sexually transmitted illness (STI) syphilis. AdvaCare Pharma is the CE and ISO-compliant manufacturer of this product.

Specimen

Form

Packaging

What is a Syphilis Test Kit?

Product Category:

Rapid Test Kits

Indicated Use:

Sub-Category:

Infectious Disease

A Syphilis Test Kit is a medical diagnostic tool used to qualitatively detect antibodies associated with the bacteria Treponema pallidum (TP) in a sample of whole blood or serum/plasma. Rapid testing can aid in the diagnosis of an infection, which speeds up treatment and reduces the spread of the disease.

The (anti-tp) syphilis rapid test kit is based on chromatographic immunoassay technology and can be used with either a whole blood or serum/plasma sample. These serological tests do not require sophisticated equipment and thus can be utilized in remote locations or regions with limited access to laboratories.

AdvaCare Pharma is the manufacturer of Syphilis Test Kits. These kits are manufactured in ISO and CE-certified facilities situated in India, China, and the USA. Regular inspections of these facilities are conducted to ensure compliance and quality.

Product Specifications

Specimen

Form

Whole Blood or Serum/Plasma

Whole Blood or Serum/Plasma specimens are used for the syphilis test kit. For whole blood/serum/plasma samples, blood can be collected using standard venipuncture (2 drops) or fingerstick (50 μL) methods. If collecting serum or plasma, the sample should be centrifuged prior to transfer. The collected specimen is then transferred to the designated area of the cassette using a capillary tube or dropper. Immediately after transferring the specimen, a drop of the corresponding buffer dilution is added to initiate the test.

Cassette

Cassette is a plastic box that encloses the test strip within it. It features a designated area where the sample is placed and a window where the test result can be observed. The test strip interacts with the sample to produce the desired outcome.

The cassette design ensures convenient and accurate interpretation of the test results, making it an efficient tool for diagnostic purposes.

Strip

Strip is a thin plastic piece with a reaction pad where a visible signal will indicate a positive, negative, or invalid test result. The reaction pad contains reagents designed for the immunochromatographic assay.

To initiate the test, the strip is placed in the specimen sample, specifically at the arrow end.

Why are we a leading Syphilis Test Kit manufacturer?

AdvaCare Pharma is an American company manufacturing Syphilis Test Kits and our entire line of rapid testing kits at our production facilities that adhere to strict CE and ISO regulations.

AdvaCare Pharma is dedicated to producing high-quality products and providing customized solutions that cater to the specific needs of each market. Our established network extends globally to distributors, hospitals, pharmacies, NGOs, and government institutions.

Uses

What is a Syphilis Test Kit used for?

A Syphilis Test Kit is a very important diagnostic tool employed in the identification of antibodies specifically linked to syphilis infection. Syphilis, caused by the bacterium Treponema pallidum, is a sexually transmitted infection (STI) that can lead to severe complications if left untreated.

This rapid diagnostic device aids in the early detection of syphilis by identifying the presence of antibodies produced by the body in response to the infection. Syphilis Test Kits help to initiate timely treatment interventions and prevent further spread of the disease.

How is a Syphilis Test Kit used?

The utilization of a Syphilis Test Kit involves a straightforward process in the diagnosis of syphilis infection. The testing process is as follows:

A sample of the patient's blood is collected through standard venipuncture techniques. The collected blood sample may undergo further processing to isolate the components relevant to the test.
The prepared sample is carefully placed onto the designated area of either the cassette or strip of the test kit.
A buffer solution is added to the sample, initiating the reaction process.
After a specified duration, indicated in the instructions included with the kit, the test results can be observed and interpreted directly on the test device. Positive, negative, or invalid results are indicated through distinct visual cues, enabling healthcare professionals to make accurate diagnostic assessments.

How should unused Syphilis Test Kits be stored?

It is advisable to store the test kits in their original sealed pouches in order to shield them from external contaminants and various environmental factors.

Any unused test kits that exceed their expiration date should be promptly discarded to prevent the potential compromise of test accuracy. Keep the test kits away from direct exposure to sunlight, moisture, and excessive heat, as these conditions may adversely affect their performance and reliability.

What is the best method for disposing of Syphilis Test Kits?

The disposal of Syphilis Test Kits should be conducted in accordance with established guidelines for medical waste management as mandated by local health authorities. Generally, used test kits, along with any associated materials, should be securely sealed in a designated biohazardous waste container to prevent potential contamination and exposure to hazardous substances.

What are the advantages of using a syphilis test kit?

Syphilis test kits have several advantages:

Rapid results, ease of use, and accessibility. Rapid testing enables timely diagnosis and treatment of syphilis infection, reducing the risk of transmission and progression to more severe stages of the disease.
The simplicity of the test procedure makes it suitable for use in various settings, including clinical laboratories, and community-based screening programs.
The availability of syphilis test kits encourages widespread screening efforts, particularly in resource-limited settings where access to laboratory-based testing may be limited.

How is a syphilis test kit used in clinical settings?

In clinical settings, a syphilis test kit is utilized as a rapid diagnostic tool to screen individuals for the presence of antibodies specific to Treponema pallidum, the bacterium responsible for syphilis infection.

The steps are as follows:

Healthcare professionals collect a specimen, standardly whole blood or serum/plasma, from the patient using standard venipuncture or fingerstick techniques.
The collected sample is then applied to the designated area of the test cassette or strip, followed by the addition of a buffer solution.
After a specified incubation period, the test results are interpreted directly on the test device, supplying valuable information for diagnosis and management decisions.

What function do test kits for syphilis serve in sexual health clinics?

In sexual health clinics, syphilis test kits detect syphilis infection among individuals at risk of sexually transmitted infections (STIs). Sexual health professionals utilize these kits to conduct rapid syphilis testing during routine check-ups, STI screenings, and partner notification services.

Through offering convenient and accessible testing options, syphilis test kits empower individuals to take control of their sexual health and make informed decisions regarding prevention, treatment, and follow-up care.

The timely identification of syphilis cases through test kits enables healthcare providers to initiate appropriate interventions, such as treatment and partner management, to prevent further transmission within the community.

How do syphilis test kits benefit resource-limited settings?

In resource-limited settings, syphilis test kits hold several benefits that contribute to better healthcare delivery and disease control efforts:

These kits are a cheap and efficient means of conducting syphilis screening and diagnosis, requiring minimal infrastructure and technical expertise. As such, they are well-suited for use in remote or underserved areas where access to laboratory-based testing facilities may be limited.
Syphilis test kits enable frontline healthcare providers, including community health workers and outreach workers, to perform rapid testing in diverse settings, such as clinics, mobile health units, and outreach sites.

Public health programs can leverage syphilis test kits for targeted screening initiatives among high-risk populations, such as sexually active individuals, pregnant individuals, and individuals living with HIV. The availability of syphilis test kits supports surveillance activities, allowing health authorities to monitor disease prevalence, track trends, and tailor intervention strategies to successfully address the burden of syphilis within populations.

FAQs

How does a Syphilis Test Kit work?

It works by detecting antibodies that have been produced by the body as a response to Treponema pallidum, which is the bacterium responsible for Syphilis infections. The test kit features an immunoassay that will react with these antibodies, producing a visible result.

Can a Syphilis Test Kit differentiate between different stages of Syphilis infection?

These kits are designed to detect the presence of antibodies, but they do not distinguish between different stages of Syphilis infection. It may be necessary to conduct further testing or clinical examinations to determine the stage of the infection.

What is the typical testing time for a Syphilis Test Kit?

Syphilis rapid test kits typically take about 10-20 minutes to show a result.

When should a strip or a cassette be used?

The decision between test strips and test cassettes may depend on factors such as result readability and cost-effectiveness. Some providers favor cassettes for clear results, and others prefer strips for their simplicity and lower cost.

Does your Syphilis Test Kit bear the CE mark?

Our medical devices are certified with the CE mark, signifying compliance with European Union regulations. Moreover, our manufacturing procedures adhere rigorously to ISO standards for consistent quality and safety assurance.

Can I receive assistance with regulatory matters for importing your Syphilis Test Kit?

Yes, we extend regulatory support and guidance to our distributors, aiding in adherence to local regulations and facilitating the smooth importation of our medical devices. Backed by our proficient Regulatory Affairs Department, comprising experts such as pharmacists, biomedical engineers, QA professionals, and documentation specialists, we ensure a seamless product registration process.

Is it possible to sell your Syphilis Test Kit to labs, hospitals and clinics?

Yes, our medical devices are suitable for distribution in various healthcare settings, including hospitals, clinics, pharmacies, and other medical institutions. With our streamlined distributor verification process, getting started is simple. Reach out to our International Sales Department to learn more about distributing our medical devices in your market.

References

Current Standards for Diagnosis and Treatment of Syphilis: Selection of Some Practical Issues

This study discusses the importance of following guidelines for the diagnosis and treatment of syphilis based on European and U.S. guidelines. It emphasizes the necessity of using scientifically proven diagnostic and therapeutic approaches.

Syphilis Guide: Screening and Diagnostic Testing

This guide focuses on the management of primary, secondary, latent, and tertiary syphilis, including screening and diagnostic testing. It highlights the significance of screening asymptomatic individuals for syphilis as part of routine medical care.

*Regulatory compliance may vary according to production standard, import requirements and/or manufacturing origin.