Product descrition Dewei HIV/Syphilis Combo performs qualitative analysis by detecting
antibodies specific to HIV-1, HIV-2 and Syphilis (Treponema
pallidum) in serum, plasma and whole blood using
immunochromatography. With a simple test method, HIV and/or
syphilis infection status can be discriminated, and with its high
sensitivity and specificity, the screening test result can be
obtained within 15 minutes. Intended use This product performs qualitative analysis by detecting HIV-1/2 and
Syphilis (Treponema pallidum) specific antibodies in serum, plasma
and whole blood.
Storage and stability
Store as packaged in the sealed pouch at 2-30ºC. The test is stable
until the expiration date marked on its sealed pouch. The test must
remain in the sealed pouch until use. Do not freeze.
Features - Simultaneous detection of HIV-1/2 and Syphilis in one test
- Easy to use, Easy to read and interpret
- Discrimination between HIV-1 and HIV-2 antibodies
- Room temperature storage
Limitations
This test is for in vitro diagnostic use only
This test has been developed for testing Whole Blod/Serum/Plasma
specimens only. The performance of the test using other specimens
has not been substantiated
This test is a qualtative assa. l is not designed to determine the
quantitative concentration of Hlv 1.2 antibody and/or syphiis
antibodyAs with all diagnostic tests, all results must be
considered with other clinical information available to the
physician.fthe test result is negative and clinical symptoms
persist, additional follow-up testing using other clinical methods
is recommended. A negative result atany time does not preclude the
possibility of HlV12 and/or syphilis infection.
Test procedure
Allow test cassette, specimen, and/or controls to equilibrate to
room temperature (15-30°C) prior to testingBring the pouch to room
temperature beore opening it. Remove the test cassette from the
sealed pouch and use it as soon as possible. Best resultswill be
obtained if the assav is performed within one hour.
Place the test cassette on a clean and level surface. Hod the
droper vericaly and transfer 2 drops of serum r plasma
approximately 50uL) to thespecimen area, then add 1 drop of buffer
(approximately 40,L), respectively. Start the timer. See the
llustration belowFor Venipuncture Whole Blood secimen: Hold the
dropper verticaly and transfer 3 drops of whole blood approximately
75 aL) to the specimen areathen add 1 drop of buffer (approximately
40 uL), and start the timer. See illustration belowFor Fingerstick
Whole Blood specimen: T use a capilay tube: Fil the capllary tube
and transfer approximately 75 pl. of fingerstick whole
bloodspecimen to the specimen area of test cassette, then add 1
drop of buffer (approximately 40 pL) and start the timer. See
ilustration below.Wait for the colored ine(s) to appea. The test
result should be read at 10 minutes. Do not interpret the result
after 20 minutes.
Performance characteristics HIV 1.2 The HIV 1.2 Rapid Test (Whole Blood/Serum/Plasma) has correctly
identified specimens of a seroconversion panel and has been
compared to a leading commercial ELISA HIV test using clinical
specimens. The results show that the relative sensitivity of the
HIV 1.2 Rapid Test (Whole Blood/Serum/Plasma) is >99.99% and the
relative specificity is 99.88%. | Method | ELISA | Total Results | | HIV 1.2 Rapid Test | Results | Positive | Negative | | Positive | 130 | 2 | 132 | | Negative | 0 | 1683 | 1683 | | Total Result | 130 | 1685 | 1815 |
Relative sensitivity: >99.99% (97.5%CI*:97.20%~100.0%);
Relative specificity: 99.88% (95%Cl*: 99.57%~99.99%);
Accuracy: 99.89% (95%Cl*:99.60%~99.99%).
*Confidence Intervals
Syphilis
The Syphilis Rapid Test (Whole Blood/Serum/Plasma) has correctly
identified specimens of a seroconversion panel and has been
compared to a
leading commercial TPPA Syphilis test using clinical specimens. The
results show that the relative sensitivity of the Syphilis Rapid
Test (Whole
Blood/Serum/Plasma) is >99.9% and the relative specificity is
99.7%.
| Method | TPPA | Total Results | | Syphilis Rapid Test | Results | Positive | Negative | | Positive | 130 | 1 | 131 | | Negative | 0 | 299 | 299 | | Total Result | 130 | 300 | 430 |
Relative sensitivity: >99.9% (95%Cl*: 97.7%~100.0%);
Relative specificity: 99.7% (95%Cl*: 98.2%~100.0%);
Accuracy: 99.8% (95%Cl*: 98.2%~100.0%).
*Confidence Intervals Questions about HIV: | 1 | What happens when you are HIV positive? | When a person becomes infected with HIV,the virus attacks and
weakens the immune system. As the immune system weakens, the person
is at risk for getting life-threatening infections and cancers.
When that happens, the illness is called AIDS. Once a person has
the virus, it stays inside the body for life. | | 2 | How long do HIV patients live? | Key points.With the right treatment and care, people with HIV can
live a normal lifespan. People who have a good response to HIV
treatment have excellent long-term prospects. You can increase your
life expectancy by not smoking and having a healthy lifestyle. | | 3 | How does HIV affect your life? | People with HIV have a higher chance of developing mood, anxiety,
and cognitive disorders. For example, depression is one of the most
common mental health conditions faced by people with HIV. It is
important to remember that mental disorders are treatable. People
who have a mental disorder can recover. | | 4 | Can you live with HIV without knowing? | Most people experience a short flu-like illness 2 to 6 weeks after
HIV infection, which lasts for a week or 2. After these symptoms
disappear, HIV may not cause any symptoms for many years, although
the virus continues to damage your immune system. This means many
people with HIV do not know they're infected. | | 5 | What to do if positive for HIV? | The first step after testing positive for HIV is to see a health
care provider, even if you do not feel sick. Prompt medical care
and treatment with HIV medicines as soon as possible is the best
way to stay healthy. | | 6 | Can I stay with HIV positive person? | People with HIV who take HIV medicine exactly as prescribed and get
and keep an undetectable viral load can stay healthy and will not
transmit HIV to their HIV-negative partners through sex. | | 7 | How long can HIV stay alive? | HIV lives the longest in a syringe at room temperature, but can
still live up to 7 days at higher temperatures. | | 8 | Can HIV be cured? | There's no cure for HIV / AIDS . Once you have the infection, your
body can't get rid of it. But there are medicines that can control
HIV and prevent complications. Everyone diagnosed with HIV should
take antiretroviral therapy medicines, also called ART. | | 9 | Can people with HIV have kids? | A diagnosis of HIV does not mean you can't have children.
But you can pass HIV to your baby during the pregnancy, while in
labor, while giving birth, or by breastfeeding. The good news is
that there are many ways to lower the risk of passing HIV to your
unborn baby to almost zero. | | 10 | What are the 7 warning signs of HIV? | Symptoms
Fever.
Headache.
Muscle aches and joint pain.
Rash.
Sore throat and painful mouth sores.
Swollen lymph glands, also called nodes, mainly on the neck.
Diarrhea.
Weight loss.
ect. |
Questions about Syphilis: | 1 | Can syphilis be cured? | Syphilis is simple to cure when it's found and treated in its early
stages. The preferred treatment at all stages is penicillin. This
antibiotic medicine can kill the bacteria that causes syphilis. If
you're allergic to penicillin, your health care team may suggest
another antibiotic. | | 2 | What are the four symptoms of syphilis? | These syphilis symptoms may come and go for up to 2 years. They
include body rashes that last 2 – 6 weeks — often on the palms of
your hands and the soles of your feet. There are lots of other
symptoms, including mild fever, fatigue, sore throat, hair loss,
weight loss, swollen glands, headache, and muscle pains. | | 3 | Can you live a normal life after syphilis? | Antibiotics can treat syphilis in the early stages. Syphilis
doesn't cause long-term health problems if you receive treatment
early. | | 4 | What happens when you have syphilis? | Without treatment, syphilis can damage the heart, brain or other
organs. It can become life-threatening. Early syphilis can be
cured, sometimes with a single shot of medicine called penicillin.
That's why it's key to get a health care checkup as soon as you
notice any symptoms of syphilis. | | 5 | Is syphilis a lifelong STD? | Syphilis is a highly contagious disease that is caused most often
through sexualcontact. It is 100% curable if treated correctly with
antibiotics. If your infection is left untreated, even if your
symptoms go away, it can cause very serious, long-term health
problems and even death. | | 6 | Will syphilis stay with you forever? | However, that does not mean the infection has gone away—only
antibiotics can cure syphilis. An antibiotic injection is usually
enough to cure syphilis. However, untreated syphilis can progress
to the fourth stage, which can be serious and even
life-threatening. | | 7 | What does syphilis look like on a man? | It can cause sores that may occur on or near the genitals, anus,
rectum, mouth, or lips. It may also cause a rash and other symptoms
like swollen lymph glands. Syphilis in people with penises can be
diagnosed with a swab test, physical exam, or blood test. It can be
treated successfully with antibiotics | | 8 | How does a woman know if she has syphilis? | Signs vary in each stage. Primary Stage: The first sign of syphilis
is often a small, round, firm sore. These appear at the place where
it entered the body such as the vulva, vaginatongue, or lips. These
signs may be inside thevagina. | | 9 | What STDs are not curable? | Viruses such as HIV, genital herpes, human papillomavirus,
hepatitis, and cytomegalovirus cause STDs/STIs that cannot be
cured. People with an STI caused by a virus will be infected for
life and will always be at risk of infecting their sexualpartners. | | 10 | Can syphilis be transmitted through kissing? | Syphilis is more commonly transmitted through oral, anal or front
hole sex but it can sometimes be transmitted via kissing. This is
only possible when someone has visible sores (also known as
chancres) in their mouth. Chancres are small sores, which are often
painless and can go unnoticed within your mouth. |
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