Intended Use

The Syphilis Rapid test cassettes(Serum/Plasma/whole blood) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma to aid in the diagnosis of Syphilis.Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane. Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly increased since 1985. Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of

prostitution among drug users. One study reported that a large number of HIV- infected females exhibited reactive Syphilis serological test results.

Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis.Primary Syphilis infection is defined by the presence of a chancre at the site of inoculation. The antibody response to the TP bacterium can be detected within 4 to 7 days after the chancre appears.The infection remains detectable until the patient receives adequate treatment.The Syphilis Rapid Test (Serum/Plasma/whole blood) utilizes a double antigen combination of a Syphilis antigen coated particles and a Syphilis antigen to detect TP antibodies (IgG and IgM) qualitatively and selectively in serum or plasma or whole blood.

The Syphilis Rapid Test (Serum/Plasma/whole blood)is a qualitative membrane based immunoassay for the detection of TP antibodies (IgG and IgM) in serum or plasma or whole blood. In this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the test. After specimen is added to the specimen well of the test, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized Syphilis antigens. If the specimen contains TP antibodies, a colored line will appear in the test line region indicating a positive result. The double antigen test can detect both IgM and IgG in specimens. If the specimen does not contain TP antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Specification

Read time	10-20 min
Shelf life	36 months
Store temperature	2-30℃
Operation temperature	15-30℃
Sensitivity	99.9%
Specificity	99.3%
Accuracy	99.6%

Why To Test

1.What is Syphilis ?

Syphilis is a sexually transmitted infection (STI) caused by the bacterium Treponema pallidum, a spiral-shaped, microaerophilic spirochete.It progresses through distinct stages (primary, secondary, latent, and tertiary), each with varying symptoms and infectiousness. If untreated, syphilis can lead to severe damage to the heart, brain, nerves, and other organs, and may be fatal. It is also known as the "great imitator" due to its diverse and often misleading clinical presentations. Congenital syphilis occurs when the infection is transmitted from mother to fetus during pregnancy, potentially causing stillbirth, neonatal death, or birth defects.

2.How does Syphilis spread?

The progression of syphilis is divided into several distinct stages, each with characteristic symptoms. If left untreated, it can lead to serious health complications.

Key modes include:

Sexual contact: Exposure to sores or fluids from an infected person.
Vertical transmission: From an infected pregnant person to the fetus via the placenta or during delivery.
Rare cases: Blood transfusion, needle-stick injuries, or kissing if oral lesions are present.

Syphilis cannot be spread through casual contact with objects like toilet seats, swimming pools, or shared utensils.

3.What are the symptoms of Syphilis and severe Syphilis?

Syphilis is a sexually transmitted infection that progresses through distinct stages, each with characteristic symptoms. If left untreated, it can lead to serious health complications.

Stage 1: Primary Syphilis

The first sign is typically a small, painless sore or ulcer called a chancre at the site of infection (e.g., genitals, anus, or mouth) .The chancre is usually firm, round, and heals on its own within 3 to 6 weeks, even without treatment. The infection, however, persists in the body.

Stage 2: Secondary Syphilis

This stage often begins with a non-itchy skin rash that can appear on one or more areas of the body, including the palms of the hands and the soles of the feet .Other symptoms may include fever, swollen lymph glands, sore throat, patchy hair loss, headaches, weight loss, muscle aches, and fatigue . These symptoms will also resolve without treatment, but the infection will advance .

Latent Stage

This is a period with no visible signs or symptoms, yet the bacteria remain in the body. The infection can persist for years .

Stage 3: Severe (Tertiary) Syphilis and Complications

This serious stage can develop 10-30 years after the initial infection. It can damage internal organs, including the brain, nerves, eyes, heart, and blood vessels, potentially leading to death.

Severe symptoms may include:

Difficulty coordinating muscle movements, paralysis, and numbness.
Gradual blindness and dementia.
Severe headache, changes in mental state, and personality changes (symptoms of neurosyphilis).
Heart disease and damage to blood vessels.

Key Considerations:

Asymptomatic Nature: The absence of symptoms, especially during the latent stage, does not mean the infection is gone. Diagnosis often relies on blood tests .
Congenital Syphilis: An infected pregnant person can pass the disease to the fetus, potentially resulting in stillbirth, or serious health problems for the newborn .

Test Method

POSITIVE:* Two colored lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.