STD Self-testing Bundle Basic HIV+C+G (blood/urine sample)
home screening for HIV 1/2 (+All Sub Types), Chlamydia and Gonorrhea.
Includes the following: 1 x HIV 1+2, 5ht Generation, Whole Blood Test, (1 x Chlamydia, 1 x Gonorrhea) Urine / Swab Test
- Clinically confirmed STD Self-testing
- Sensitivity 99.9% – Specificity 99.9%
- Used in hospital, clinics and test centers.
- Easy to use, detailed instruction manual.
- A fast visible result in 20 minutes.
- Discreet and anonymous shipping.
- 24 / 7 Online Support
STD Self-testing & treatment in the USA
STD (Sexually Transmitted Disease).
STD (Sexually Transmitted Diseases) are a few of the most frequently reported illness in the United States. It is approximated that there are practically 20 million brand-new Sexually Transmitted Disease infections each year. Of these brand-new infections, half are amongst youths age 15-24. Get STD home self-test bundle basic test kit today, and get tested for the most common STDs in the privacy of your own home.
Lots of Sexually transmitted diseases can be quickly detected and medicated. It’s no secret that lots of people will not have any signs when they are infected with a Sexually Transmitted Disease. Makes screening for Sexually transmitted diseases essential to prevent severe health issue from unattended Sexually Transmitted Disease infections. STD Home self-testing bundle basic Kit for the home screening of STD
Ways to safeguard yourself from getting a Sexually Transmitted Disease are:
2. Utilizing protection such as condoms.
3. Remaining in an Equally Monogamous Relationship.
4. Minimizing your Variety Of Sex Partners.
Did you understand that you are five times most likely to agreement HIV if you currently have a sexually transmitted disease? 1 in 2 sexually active youths will get a sexually transmitted disease before the age of 25. A lot of them will not know it. STD Home self-testing bundle basic test kit for the home screening of the most common STDs...
What can happen if ignored!
Neglected STIs can trigger severe problems such as:
1. Infertility and damage to reproductive organs.2
2. Severe disease or perhaps death in newborn infants.
3. Brain, heart and joint damage.
4. Eye (vision) loss or hearing loss.
Without treatment, STIs can often trigger issues causing server problems or even death of the infected individual.
What are the signs of infections?
Sexually sent infections (STIs) can have a variety of symptoms and signs which might be subtle or unclear or there might be no signs at all. They might go undetected up until issues happen or a partner detects his or her infection. STD Home self-testing bundle basic test kit for the home screening of STD
Symptoms and signs that may show an STI consist of:
1, Uncommon odor, discharge, burning or itching in the vaginal location.
2. Bleeding (not related to a menstrual duration).
3. Lower stomach or pelvic discomfort.
4. Discomfort throughout sex.
5. In the genital, anal area or in your mouth, blisters and or sores occurs.
6. Swelling or swelling in the groin location which might ache or tender.
7. Discharge from the penis or "leaking" of clear or cloudy fluid.
8. Burning or discomfort throughout urination or with defecation.
9.Itching feeling inside the penis.
10. Rash over the trunk, hands or feet.
Symptoms and signs might look like quickly as a couple of days after direct exposure to an infection, but for some infections, it might take years before you have any visible issues. STD home self-testing bundle basic test kit for the home screening of the most common STDs.
HIV Home Test 4th Gen Antibody IgG /IgM "Blood Sample"
screening tests for HIV 1 and HIV 2 + all Sub Types: (A,B,C,D,E,F,G,H and O)
INTENDED INTENDED USE
The One-Step HIV1/2 test is for the qualitative detection of antibodies specific to human immunodeficiency of virus (HIV) in a whole blood sample. This test kit is intended as an aid in the diagnosis of HIV1 and HIV2 infection, within the window period 1 to 12 weeks post exposure.
The human immunodeficiency virus (HIV) is the causative agent of acquired immune deficiency syndrome (AIDS). Antibodies to the virus are produced in response to infection with HIV and can be detected using standard diagnostic test procedures. Antibodies in the blood slowly rise in response to the infection. Persistent antibodies to HIV usually develop within one week to 3 months of infection. The presence of antibodies to HIV is indicative of infection with HIV. The One-Step HIV1/2 test uses a mixture of recombinant proteins (p24, gp36, and gp41) known to have antigenic determinants that are present in all strains of HIV isolated.
The One-Step HIV1/2 test has been designed to detect the HIV infection through visual interpretation of color development in the test device, which is a sandwich solid phase gold conjugate immunoassay. The test device contains membrane strip that is pre-coated with HIV antigens on the test band region (1,2) and goat-anti-mouse polyclonal antibody on the control band region. The HIV antigens-colloid gold conjugate pad is placed at the end of the membrane.
When the HIV specific antibodies are present in samples, the mixture of colloid gold conjugate, sample and developer buffer moves along the membrane chromatographically by capillary action. This mixture then migrates to the test band region (1,2) and forms a visible line as the antigen-antibody-antigen complex forms. Therefore, the formation of visible precipitation in test band region 1 or 2 occurs when the sample is possible for the HIV specific antibodies.
When the HIV specific antibodies are absent in the sample, no visible colorband will form on the test line region (1,2). A colored band will always appear at the control region. This control band serves as a procedural indicator for the proper performance of the test and the device.
LIMITATION OF OF PROCEDURE
1. The assay is designed for human blood only.
2. This test kit is to be used for the qualitative detection of antibodies to HIV.
3.A negative result doe’s rule out infection by HIV because the antibodies to HIV may be absent or may not be present in sufficient quality to be detected at an early stage of infection.
QUALITY QUALITY CONTROL
The procedural control is included in the test. A colored band appearing on the control region of the membrane indicates the proper performance of the test and the device.
PERFORMANCE PERFORMANCE CHARACTERISTICS
The recombinant antigens used in the HIV 1/2 Rapid Test Device (Whole Blood Sample) is encoded by genes for the glycoproteins on the viral envelope. The HIV 1/2 Rapid Test Device Whole Blood Sample) is highly specific for anti-HIV-1 and/or -2 compared to a leading commercial HIV EIA test.
Within-run precision has been determined by using 15 replicates of three specimens: a negative, a low positive and a high positive. The negative, low positive and high positive values were correctly identified 99.5% of the time.
Chlamydia Rapid Test Device at Home
The Chlamydia Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in the female cervical swab, male urethral swab, and female and male urine specimens to aid in the diagnosis of Chlamydia infection.
Chlamydia trachomatis is the most common cause of sexually transmitted venereal infection in the world. It is composed of elementary bodies (the infectious form) and reticulate or inclusion bodies (the replicating form). Chlamydia trachomatis has both a high prevalence and asymptomatic carriage rate, with frequent serious complications in both women and neonates. Complications of Chlamydia infection in women include cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increased incidence of ectopic pregnancy and infertility.
Vertical transmission of the disease during parturition from to neonate can result in inclusion conjunctivitis or pneumonia.
In men, a complication of Chlamydia includes urethritis and epididymitis. At least 40% of the nongonococcal urethritis cases are associated with Chlamydia infection. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are asymptomatic.
Traditionally, Chlamydia infection has been diagnosed by detection of Chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and specific laboratory method, but it is labor intensive, expensive, long (18-72 hours) and not routinely available in most situations.
The Chlamydia Rapid Test Device (Swab/Urine) is a rapid test to qualitatively detect the Chlamydia antigen from the female cervical swab, male urethral swab and female, and male urine specimens.
The Chlamydia Rapid Test Device (Swab/Urine) is a qualitative, lateral flow immunoassay for the detection of Chlamydia antigen from female cervical, male urethral and female and male urine. In the test, an antibody specific to the Chlamydia antigen is coated on the test line region of the test. During testing, the extracted antigen solution reacts with an antibody to Chlamydia that is coated onto particles. The mixture migrates up to react with the antibody to Chlamydia on the membrane and generates a color line in the test region.
The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The test contains Chlamydia antibody-coated particles and Chlamydia antibodies coated on the membrane.
For women attending STD clinics and other high-risk populations, the prevalence of Chlamydia infection has been repeated to between 20% and 30%. In a low-risk population such as those patients attending obstetrics and gynecology clinics, the prevalence is approximately 5% or less. Reports show that for men attending STD clinics, the prevalence of Chlamydia infection is approximately 8% in asymptomatic men and 11% in symptomatic men. Normal carriage rates of Chlamydia in asymptomatic men are less than 5%.
The Chlamydia Rapid Test Device (Swab/Urine) has been evaluated with specimens obtained from patients of STD clinics. PCR is used as the reference method for the Chlamydia Rapid Test Device (Swab/Urine). Specimens were considered positive if PCR indicated a positive result. Specimens were considered negative if PCR indicated a negative result. The results show that Chlamydia Rapid Test Device (Swab/Urine) has a high sensitivity relative to PCR.
The Chlamydia Rapid Test Device (Swab/Urine) uses an antibody that is highly specific for Chlamydia antigen in the female cervical swab, male urethral swab and female, and male urine specimens. The results show that the Chlamydia Rapid Test Device (Swab/Urine) has a high specificity relative to PCR.
The antibody used in the Chlamydia Rapid Test Device (Swab/Urine) has been shown to detect all known Chlamydia serovars. Chlamydia psittaci and Chlamydia pneumoniae strains have been tested with the Chlamydia Rapid Test Device (Swab/Urine) and were shown to cross react when tested in suspensions of 109 Colony Forming Units (CFU)/ml. Cross-reactivity with other organisms has been studied using suspensions of 109 CFU/ml. The following organisms were found negative when tested with the Chlamydia Rapid Test Device (Swab/Urine):
|Acinetobacter||Pseudomonas aeruginosa||Proteus mirabilis|
|Acinetobacter spp||Neisseria meningitides||Neisseria gonorrhea|
|Enterococcus faecalis||Salmonella choleraesuis||Group B/C Streptococcus|
|Enterococcus faecium||Candida albicans||Branhamella catarrhalis|
|Staphylococcus aureus||Protects Vulgaris|
|Klebsiella pneumoniae||Gardneralla vaginalis|
1.Sanders J.W. et al. Evaluation of an Enzyme Immunoassay for Detection of Chlamydia trachomatous in Urine of Asymptomatic Men. J.Clinical Microbiology, 32,24-27, (1994).
2.Jaschek, G. et al. Direct Detection of Chlamydia trachomatis in Urine Specimens from Symptomatic and Asymptomatic Men by Using a Rapid Polymerase Chain Reaction Assay. J. Clinical Microbiology, 31,1209-1212, (1993). 3. Schachter, J Sexually transmitted Chlamydia trachomatis infection. Postgraduate Medicine, 72, 60-69, (1982).
Gonorrhea Rapid Test Device at Home
The Gonorrhea Rapid Test Device (Swab/Urine) is a rapid chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae in the female cervical swab and male urethral swab and female, male urine specimens to aid in the diagnosis of Gonorrhea infection.
Gonorrhea is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. Gonorrhea is one of the most common infectious bacterial diseases and is most frequently transmitted during sexual intercourse, including vaginal, oral and anal sex. The causative organism can infect the throat, producing a severe sore throat. It can infect the anus and rectum, producing a condition called proctitis. With females, it can infect the vagina, irritating with drainage (vaginitis). Infection of the urethra may cause urethritis with burning, painful urination, and a discharge.
When women have symptoms, they often note vaginal discharge, increased urinary frequency, and urinary discomfort. The spread of the organism to the fallopian tubes and abdomen may cause severe lower-abdominal pain and fever. The average incubation for Gonorrhea is approximately 2 to 5 days following sexual contact with an infected partner. However, symptoms may appear as late as two weeks. A preliminary diagnosis of Gonorrhea can be made at the time of examination. In women, Gonorrhea is a common cause of pelvic inflammatory disease (PID). PID can lead to internal abscesses and long-lasting, chronic pelvic pain. PID can damage the fallopian tubes enough to cause infertility or increase the risk of ectopic pregnancy.
The Gonorrhea Rapid Test Device (Swab / Urine) is a qualitative, lateral flow immunoassay for the detection of Gonorrhea antigen from the female cervical swab and male urethral swab and female, male urine specimens. In this test, an antibody specific to the Gonorrhea antigen is coated on the test line region of the Device. During testing, the extracted antigen solution reacts with an antibody against Gonorrhea antigen that is coated onto particles. The mixture migrates up the test Device to react with the antibody against Gonorrhea antigen on the membrane and generate a colored line in the test line region. The presence of this colored line in the test line region (T) indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region (C) indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The test Device contains Gonorrhea antibody-coated particles and Gonorrhea antibody coated on the membrane.
1. The Gonorrhea Rapid Test Device (Swab/Urine) is for in vitro diagnostic use only. This test should be used for the detection of Gonorrhea antigen from the female cervical swab and male urethral swab and female, male urine specimens. Neither the quantitative value nor the rate of increase in Gonorrhea antigen concentration can be determined by this qualitative test.
2. This test will only indicate the presence of Gonorrhea antigen in specimens from both viable and non-viable Neisseria gonorrhoeae. The performance with other specimens has not been assessed.
3. Detection of gonococcus is dependent on the number of organisms present in the specimen. This can be affected by specimen collection methods and patient factors such as age, history of Sexually Transmitted Diseases (STDs), the presence of symptoms, etc. The minimum detection level of this test may vary according to serovar.
4. Therapeutic failure or success cannot be determined as an antigen may persist following appropriate antimicrobial therapy.
5. Excessive blood (>20 µL in case of female swabs and >10 µL in case of male swabs) may cause false positive results.
6. Endocervical samples from female patients should not be collected during the menstrual period.
7. In the case of Urinary tract infection, the possibility of false positive should be considered.
EXPECTED VALUES Gonorrhea is a common adult disease around the world. With 351,852 Gonorrhea cases reported in 2002 (125.0 cases per 100,000 people), Gonorrhea is the second most frequently reported communicable disease in India. Gonorrhea remains a frequently reported sexually transmitted disease, with an estimated more than 300,000 new infections occurring each year in India. .2 A significant proportion of those with infection are asymptomatic (up to 80% among women and 10% among men), and many victims will not go to see the doctor, making the prevalence higher than the report rate in fact.
For example, In 1997, health care workers reported 324,901 cases of Gonorrhea in Australia to the Department of Health in Australia. While the Institute of Medicine, however, estimates that 650,000~800,000 cases of Gonorrhea occur annually in Australia. Worldwide, an estimated 62 million new cases of Gonorrhea occurred in 1997.2,3,4 A significant number of women may be asymptomatic and may be at risk for chronic or disseminated infection.4 In the case of pregnant women, there is a potential risk of passage of Gonorrhea to the newborn.
Clinical Study The Gonorrhea Rapid Test Device (Swab / Urine) has been evaluated with specimens obtained from patients of STD clinics. Culture is used as the reference method for the Gonorrhea Rapid Test Device (Swab / Urine). Specimens were considered positive if Culture indicated a positive result. Specimens were considered negative if Culture indicated a negative result.
For Female Cervical Urine / Swab Specimens:
Relative sensatvity: 91.5% (82,5%-96.8%)*
Relative specificity: 96.1%(88.9%-99.2%)*
*95% Confidence Interval
For Male Urethral Urine / Swab Specimens:
Relative sensatvity: 89.2% (81.1%-94.7%)*
Relative specificity: 95.5%(90.1%-99.3%)*
*95% Confidence Interval
Cross-reactivity with other organisms has been studied using suspensions of 107 org/test. The following organisms were found negative when tested with the Gonorrhea Rapid Test Device (Swab/Urine):
|Acinetobacter||Pseudomonas aeruginosa||Chlamydia trachomatis|
|Acinetobacter spp||Gardnerella vaginalis||Group B/C Streptococcus|
|Enterococcus faecalis||Salmonella choleraesuis||Hemophilus influenza|
|Enterococcus faecium||Candida albicans||Klebsiella pneumoniae|
|Staphylococcus aureus||Protects Vulgaris||Proteus mirabilis|
1. Knapp, J.S. et al. Neisseria gonorrhoeae. Manual of Clinical Microbiology, Sixth Edition, ASM Press, Washington DC., 324-325 (1995).
2. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines 2002. Morbidity and Mortality Weekly Report (2002), 51(RR-6)
3. Forbes B.A., Sahm D.F., Weissfeld A.S. Neisseria and Moraxella catarrhalis. Bailey & Scott’s Diagnostic Microbiology, Tenth Edition, Mosby, St. Louis, 597-605 (1998).
4. Summary of the Notifiable Diseases, United States, 1998, Morbidity and Mortality Weekly Report (1999), 47(53): 1-93.
5. National Institute of Allergy and Infectious Diseases, National Institute of Health, US Department of Health and Human Services, NIAID Fact Sheet on Gonorrhea, October 2004.
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