Sensitive One Step Syphilis Rapid Test Kit , Home Diagnosis Testing Kits infectious disease testing

Application:

The Syphilis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.

Description:

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 coc/aine epidemic and the high incidence of prostitution among drug users. 3 One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis. Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies 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 Cassette (Whole Blood/Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in whole blood, serum or plasma.

How to use?

For ISY-301:

Allow the test, specimen and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Method:
2.1 Transfer 150l serum or plasma to bottom of the test tube carefully. See the below illustration
2.2 With arrows pointing toward the serum or plasma specimen, immerse the test dipstick vertically into the specimen solution of the test tube and then start the timer. Do not pass the maximum line (MAX) on the test Dipstick when immersing the test dipstick. See the below
illustration
2.3 Leave the Dipstick in the test tube and wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.

For ISY-302:

Allow the test, specimen and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 1 drop of serum or plasma (approx.40ul) to the specimen well of the test cassette, then add 1 drop of buffer (approx. 40ul) and start the timer. Avoid trapping air bubbles in the specimen well.
3. Wait for color line (s) appear. Read the result at 5 minutes, do not interpret the result after 20 minutes.

For ISY-401:

Allow the test, specimen, buffer and/or controls to reach room temperature (15- 30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it as soon as possible.
2. Place the test cards on a clean and level desk, then peel off the strip label of the test cards, stick the test dipstick onto it as soon as possible before testing.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 80 ul of fingerstick whole blood specimen to the specimen area of test dipstick, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 80 ul) to fall into the specimen area of test dipstick, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.

For ISY-402:

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80 ul) to the specimen area, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 80 m mL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
·To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 80 ul) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.

According to a recent report from the CDC, the incidence of newborn syphilis has reached alarming levels, prompting urgent attention. Over the past decade, cases of newborn syphilis have increased by more than tenfold, with a shocking surge of nearly 32% within a single year. These statistics highlight the critical need for immediate action to address this concerning public health issue.

To combat the rising cases of newborn syphilis, it is crucial to emphasize the importance of prenatal screenings for expectant mothers. Routine testing for syphilis during pregnancy can help detect the infection early and ensure timely treatment. By undergoing regular check-ups and screenings, pregnant women can protect their own health and significantly reduce the risk of transmitting syphilis to their unborn babies.

Preventing the transmission of syphilis from mother to child requires a comprehensive approach. In addition to prenatal screenings, it is essential to educate expectant mothers about safe practices and preventive measures. This includes promoting safe sex/ual behaviors, promoting the use of barrier methods (such as condoms), and encouraging open communication between partners about sex/ual health. By raising awareness, providing accessible healthcare services, and promoting preventive strategies, we can work together to combat the alarming rise of newborn syphilis cases and protect the well-being of both mothers and their babies.