Clearview HIV 1/2 STAT-PAK is a rapid qualitative screening test for the detection of antibodies to HIV-1 and HIV-2 in human whole blood, serum and plasma.

CLIA Waived, simple two-step procedure for whole blood.

Clearly different

Clearview's innovative technology provides highly accurate detection of HIV-1 and HIV-2.

• Fast: two easy steps with a reactive result in as little as 15 minutes
• Easy: CLIA-waived, easy-to-use test requires no training
• Reliable: built-in control ensures accuracy
• Flexible: use with multiple specimen types - whole blood (fingerstick or venipuncture), serum or plasma

Clearly better

Clearview HIV 1/2 STAT-PAK provides answers for immediate and necessary treatment.

• Supports early screening and diagnosis of human immunodeficiency virus
• Detection and proper treatment may prevent transmission to an unborn child, as well as to sexual partners
• Early diagnosis and treatment can lead to a prolonged survival rate
• 24 month shelf life provides flexibility to the laboratory
• Reliable results - 99.7% sensitive, 99.9% specific

About HIV

Human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) remain leading causes of illness and death in the United States. However, at the end of 2003, of the approximately 1.0--1.2 million persons estimated to be living with HIV in the United States, an estimated one quarter (252,000--312,000 persons) were unaware of their infection and therefore unable to benefit from clinical care to reduce morbidity and mortality. A number of these persons are likely to have transmitted HIV unknowingly. ¹

Treatment has improved survival rates dramatically, especially since the introduction of highly active antiretroviral therapy (HAART) in 1995. However, progress in effecting earlier diagnosis has been insufficient. The good news is that the new CDC guidelines have removed much of the barriers to screening and now encourages testing all persons 13-64 years of age in the United States.

New HIV Screening Guidelines

In September 2006, the CDC announced revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. The new guidelines highlight:

• Screening for all patients aged 13-64 years regardless of risk
• Patients are notified that testing will be performed unless they decline (opt-out screening)
• Testing process is streamlined to lower the barriers of pre-test counseling and documented written consent
• High risk populations such as IV drug users and their sex partners and men who have sex with men should be tested annually

This represents a substantial change from earlier recommendations:

• Offer HIV testing routinely to all patients only in health-care settings with high HIV prevalence
• Conduct targeted screening on the basis of risk behaviors for patients in low-prevalence settings
• Require informed, written consent prior to testing
• Pre-test counseling

Product Overview

The Clearview HIV 1/2 STAT-PAK is a rapid in vitro qualitative immunoassay for the detection of antibodies to HIV1 and HIV 2 in human whole blood, serum and plasma.

With its simple, two-step procedure, Clearview HIV 1/2 STAT-PAK is quick and easy to use, delivering clear, dependable results in just 15 minutes. Plus, Clearview HIV 1/2 STAT-PAK is waived for whole blood and requires a very small sample amount, making it easier to run and manage in a busy laboratory environment.

Clearview HIV-1/2 STAT-PAK will help healthcare workers diagnose individual infection, prevent mother-to-child transmission, and monitor HIV prevalence.

FAQ’s

1. How sensitive is Clearview HIV 1/2 STAT-PAK?
99.7% sensitive and 99.9% specific for all sample types

2. How should Clearview HIV 1/2 STAT-PAK be stored?
Store at 8° to 30°C (46° to 86°F)

3. What type of patient sample do I have to use?
Human serum, plasma and whole blood from venipuncture or fingerstick. For Serum or Plasma, collect specimen in a tube not containing any anticoagulant (serum), and in a tube containing citrate, heparin, or EDTA (plasma). For whole blood either through venipuncture or fingerstick (fill the sample loop provided in the kit).

4. How critical is the timing?
The timing is critical and you cannot obtain the correct results if you do not follow the instructions exactly.

5. How long are the results stable?
The result can be read from 15 to 20 minutes.

6. The Test Line was fainter than the Control Line, what does this mean?
The test result is reactive even if the Test Line appears lighter or darker than the Control Line.

7. No line has appeared in the Control Window, what does this mean?
The test is invalid. You will have to use a new device and run the test again.

8. What is the shelf-life of Clearview HIV 1/2 STAT-PAK?
Up to a maximum of 24 months from the date of manufacture

9. If I add whole blood and forget to add running buffer will the test still run?
You cannot obtain the correct result. It should be tested again.

10. Would a negative result conclude that a patient does not have HIV?
A non-reactive result with Clearview HIV 1/2 STAT-PAK does not exclude the possibility of infection with HIV. A false negative result can occur in the following circumstances;

• low levels of antibody (e.g., early seroconversion specimens) are below the detection limit of the test
• infection with a variant of the virus that is less detectable by the Clearview assay configuration
• HIV antibodies in the patient that do not react with specific antigens utilized in the assay configuration - in exceptional cases this may lead to observation of false negative results
• specimens handling conditions which result in loss of HIV antibody multivalency.

11. What are the storage conditions for Serum and Plasma samples?
Serum and plasma samples can be run immediately or refrigerate them at 2 to 8°C (36 to 46°F) following collection. These specimens should be tested within 3 days of collection. If specimens are not tested within 3 days of collection, serum or plasma specimens should be frozen at -20°C (-4°F) or colder.

12. What are the storage conditions for whole blood samples?
Venous whole blood can be run immediately or refrigerated at 2 to 8°C (36 to 46°F) following collection. Venous whole blood may be stored for up to 3 days between 2 and 8°C (36 to 46°F) before testing. DO NOT FREEZE WHOLE BLOOD! Whole blood collected by fingerstick should be tested immediately.

13. What volume does the sample loop deliver?
5ul

Reference

1. www.cdc.gov

Legal

Manufactured by Chembio Diagnostic Systems, Inc., Medford, NY for Inverness Medical Professional Diagnostics under issued patents U.S. 6,352,862; 6,534,320; 5,622,871; 5,656,503;
6,187,598; 4,956,302; 6,627,459; 5,602,040; 6,228,660; 6,818,455; 5,120,643; 5,714,389; 5,989,921; 6,485982; and additional patents pending that are owned or licensed by a member of the Inverness Medical family of companies. Corresponding rights granted or pending elsewhere.