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	5-10 min
Shelf life	36 months
Store temperature	2-30℃
Operation temperature	15-30℃

Why To Test

1. What is the SP-10 test ?

The SP-10 Male Fertility Rapid Test is an at-home screening tool designed to assess a key indicator of male fertility: sperm concentration. It works by detecting the presence of the SP-10 protein, which is specific to the acrosome, a structure on the head of sperm cells . The concentration of SP-10 in semen is directly proportional to the sperm count .The test provides a qualitative result based on the World Health Organization (WHO) benchmark for a normal sperm concentration, which is 15 million sperm per milliliter (mL) or higher. A result indicating a concentration at or above this level is considered normal, while a result below may suggest a potential fertility concern . It's important to understand that this test is a preliminary screening tool and cannot replace a comprehensive laboratory semen analysis .

2. Why should someone consider taking this test?

Male factors contribute to infertility in nearly half of all couples struggling to conceive. This test is valuable because it offers a private and convenient way to conduct an initial assessment of a crucial fertility parameter.For couples planning a pregnancy, it can provide early insight and help decide if and when to consult a healthcare professional. It can also be used by any man who wants to better understand his reproductive health in a private setting .

3. Who is this test recommended for?

This test is particularly suitable for:

Couples planning pregnancy: It serves as an initial, at-home check for the male partner before seeking more extensive fertility workups .Men curious about their reproductive health: Individuals who want a private and convenient way to check a key fertility indicator .Men with specific health concerns: Those with conditions or lifestyles that might affect fertility can use it for preliminary monitoring (though results should be discussed with a doctor) .

Test Method

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

*NOTE: The intensity of the colour in the test line region (T) will vary depending on the concentration of SP-10 protein present in the specimen. Therefore, any shade of colour in the test line region (T) should be considered normal.