HIV 1 /2 STAT-PAK® Assay
HIV 1 /2 STAT-PAK® Dipstick Assay
SURE CHECK® HIV 1/ 2 Assay
Product Information

By the end of 2007 there were approximately 33 million people living with HIV/AIDS including 15.5 million women and 2 million children under the age of 15. Nearly 3 million people were newly infected with HIV/AIDS. In the same year, 2 million people died of HIV/AIDS-related causes.
HIV/AIDS is caused by infection with Human Immunodeficiency Virus, HIV 1 or HIV 2. HIV 1 is the most frequently found strain worldwide. Infection with HIV 2 is found primarily in West Africa, although infections have been identified in other areas of the world.

HIV is spread by sexual contact with an infected person, by sharing needles and/or syringes (primarily for drug injection) with someone who is infected, or, less commonly (and now very rarely in countries where blood is screened for HIV antibodies), through transfusions of infected blood or blood clotting factors. Babies born to HIV infected women may become infected before or during birth or through breast-feeding after birth. Patients with HIV/AIDS and HIV/AIDS related diseases usually have a high level of the antibody to the viruses.

The standard screening test for antibodies to HIV is the enzyme immunoassay (EIA) or ELISA which is widely used in the United States and around the world. This test requires two visits to a clinic or medical facility; one to receive pretest counseling and to have blood drawn for HIV testing, and the second to receive test results and additional counseling and if needed referrals. Rapid, point-of-care (POC) tests have been developed which produce results within 20 minutes or less and allows testing, counseling and referrals to be accomplished in one visit. Rapid tests are less costly for testing agencies to perform due to the fewer outreach visits required to deliver results. Patients receive counseling, test results and referrals (if warranted) in one visit. Also, studies have shown that rapid tests are as sensitive and specific as conventional immunoassays.

Chembio Diagnostic Systems, Inc.’s SURE CHECK® HIV 1 / 2, HIV 1/ 2 STAT-PAK® and HIV 1/ 2 STAT-PAK® Dipstick tests are easy-to-perform, single-use diagnostic tests for the rapid, visual detection of antibodies to HIV 1 and HIV 2.

Assay Features

Convenient & Cost Effective

• Ideally suited for field and point-of-care testing
• Minimal sample size required—5 µl (assay dependent) fingerstick orvenous whole blood, serum or plasma
• Room temperature storage
• Long shelf life
• No special laboratory equipment required

Time & Labor Saving

• Ready-to-Use Reagents
• Simple procedure
• Total test time of 10 to 15 minutes (assay dependent)
• No special equipment required
• Results are easy to interpret

Reliable Results

• Built-in IgG procedural control
• Highly sensitive and specific

New! DPP® HIV 1/2 Screen
for Use with Oral Fluid or Blood Samples
Product Information

By the end of 2007 there were approximately 33 million people living with HIV/AIDS including 15.5 million women and 2 million children under the age of 15. Nearly 3 million people were newly infected with HIV/AIDS. In the same year, 2 million people died of HIV/AIDS-related causes.
HIV/AIDS is caused by infection with Human Immunodeficiency Virus, HIV 1 or HIV 2. HIV 1 is the most frequently found strain worldwide. Infection with HIV 2 is found primarily in West Africa, although infections have been identified in other areas of the world.

HIV is spread by sexual contact with an infected person, by sharing needles and/or syringes (primarily for drug injection) with someone who is infected, or, less commonly (and now very rarely in countries where blood is screened for HIV antibodies), through transfusions of infected blood or blood clotting factors. Babies born to HIV infected women may become infected before or during birth or through breast-feeding after birth. Patients with HIV/AIDS and HIV/AIDS related diseases usually have a high level of the antibody to the viruses.

The standard screening test for antibodies to HIV is the enzyme immunoassay (EIA) or ELISA which is widely used in the United States and around the world. This test requires two visits to a clinic or medical facility; one to receive pretest counseling and to have blood drawn for HIV testing, and the second to receive test results and additional counseling and if needed referrals. Rapid, point-of-care (POC) tests have been developed which produce results within 20 minutes or less and allows testing, counseling and referrals to be accomplished in one visit. Rapid tests are less costly for testing agencies to perform due to the fewer outreach visits required to deliver results. Patients receive counseling, test results and referrals (if warranted) in one visit. Also, studies have shown that rapid tests are as sensitive and specific as conventional immunoassays.

Chembio Diagnostic Systems, Inc.’s DPP® HIV 1/2 Screen, SURE CHECK® HIV 1 / 2, HIV 1/ 2 STAT-PAK® and HIV 1/ 2 STAT-PAK® Dipstick tests are easy-to-perform, single-use diagnostic tests for the rapid, visual detection of antibodies to HIV 1 and HIV 2.

New DPP® HIV 1/2 Screen
for Use with Oral Fluid, Blood, Serum and Plasma Samples
Patented DPP® System

Assay Features:

• Enables direct binding of sample to antigen
• Sharp & Distinctive Visual Results
• Simple, Flexible & Safe
• Use with Non-Invasive Oral Fluid Sample and all Blood Matrices
• Diluted Sample is Contained in Closed Vial, Available for re-test
• All of Chembio’s HIV Tests Convenient & Cost Effective
• Ideally suited for field and point-of-care testing Minimal sample size required—5 µl (assay dependent) fingerstick orvenous whole blood, serum or plasma
• Room temperature storage Long shelf life
• No special laboratory equipment required Time & Labor Saving
• Ready-to-Use Reagents Simple procedure
• Total test time of 10 to 20 minutes (assay dependent) No special equipment required
• Results are easy to interpret Reliable Results
• Built-in IgG procedural control Highly sensitive and specific
  
  
  

DPP® Syphilis Screen & Confirm
Product Information

Syphilis, caused by the bacterial spirochete Treponema pallidum, is a significant source of human morbidity and mortality worldwide. In fact, it is estimated that there are over 12 million cases of syphilis occurring worldwide every year. In the United States syphilis has a storied history. With an incidence great enough to instigate its own (and one of the earliest) specialized medical journals (American Journal of Syphilis, Gonorrhea and Venereal Disease), syphilis reached its peak incidence in the early 1940’s (approx. 450/100,000 population) and gradually tapered off over the subsequent 60 years, with a small spike in incidence during the late 1980’s. Recently the United States Centers for Disease Control (CDC) estimated an all time low in syphilis incidence in 2000, but more importantly the CDC has seen a steady increase in reported cases since then. Discussion with regards to causative factors of this rise in incidence can be found below.

Given the historical context of syphilis in humans as well the sequelae of pathological features if left untreated (including congenital syphilis of the new born), widespread guidelines have been implemented that take into account both disease progression and epidemiology.

Infection with syphilis leads to one of four clinical scenarios.

Primary Syphilis – Typical presentation is a painless genital lesion that heals spontaneously with 1 to 6 weeks.
Secondary syphilis – Typical presentation is a generalized skin manifestation, such as rash or other lesions that may persist for months.
Latent syphilis – Typically no clinical manifestations.
Tertiary syphilis – Typically occurring in untreated cases that has the potential for a wide range of systemic manifestations effecting a wide range of organ systems such as cardiac, neurologic, skeletal, and skin.

In women, infection with syphilis at any stage can be transmitted to the developing fetus with devastating consequences. For this reason current recommendations state all pregnant women to be screened for antibodies directed against T. pallidum during their first prenatal visit.

Recent data from 2007 epidemiologic studies suggest an overall syphilis incidence of 3.7/100,000 in the U.S. This number represents an overall increase of 12% from recent years and is believed to be concentrated, for the most part, in a subset group representing men who have sex with men (MSM). Extrapolation of this data suggests approximately 70,000 new cases of syphilis occurring in the U.S. annually, with a male:female ratio of 3.5:1.

Syphilis remains a significant global public health problem with the World Health Organization (WHO) estimating 12 million new cases of the disease worldwide each year including 100,000 per year in the United States and 140,000 per year in Western Europe. 

DPP® Screen & Confirm provides the most conclusive evidence, at the point-of-care (POC), of active, untreated disease as compared with current methods, thereby enabling diagnosis and treatment in a single visit to a clinic.

Standard diagnosis of syphilis is currently done using two different laboratory-based serologic tests, namely a non-treponemal screening test, usually either the Rapid Plasma Reagin (RPR) or Venereal Disese Research Laboratory (VDRL), followed by a more specific treponemal confirmatory (EIA) assay.  Chembio has developed the first dual non-treponemal & treponemal POC syphilis test. 

Utilizing Chembio’s patented Dual Path Platform technology, DPP® Screen & Confirm permits the simultaneous yet separate detection of both markers at the point of care. The test, which will be eligible for a CLIA waiver (Clinical Laboratory Improvement Act waiver allows use in point of care settings of simple to use tests), therefore represents a considerable advance in diagnosis as well as in  time to result and ease of use.

Assay Features:

• Convenient  & Cost Effective
• Ideally suited for field and point-of-care testing
• Minimal sample size required—10 µl whole blood, 5 µl serum or plasma
• Room temperature storage
• Long shelf life
• Time & Labor Saving
• Simple, two-step procedure
• Total test time of 15 minutes
• No special equipment required
• Reliable Results
• Built-in IgG procedural control Highly sensitive and specific

• Ideally suited for field and point-of-care testing
• Minimal sample size required—10 µl whole blood, 5 µl serum or plasma
• Room temperature storage
• Long shelf life

• Simple, two-step procedure
• Total test time of 15 minutes
• No special equipment required

• Built-in IgG procedural control
• Highly sensitive and specific