ORAQUICK IN-HOME HIV TEST (US FDA Version)

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Product Details:

Accuracy Sensitivity ~92%, Specificity ~99.98%
Storage Instructions Store at 36F80F (2C27C), avoid direct sunlight
Shelf Life 18-24 months (from date of manufacture)
Usage Type Single Use
Measurement Range Qualitative (Positive/Negative) detection of HIV-1/2 antibodies
Display Type Visual line readout (no digital screen)
Function Screening for HIV infection
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ORAQUICK IN-HOME HIV TEST (US FDA Version) Price And Quantity

Packaging Type Sealed box with tamper-evident components
Package Contents Test device, Developer solution vial, Test stand, Instruction booklet, Disposal bag
Time to Results 20 to 40 minutes
Intended User Adults and adolescents (age 17+) for at-home self-testing
Sample Type Oral fluid (mouth swab)
Result Interpretation One line = Negative, Two lines = Positive (requires confirmatory test)
Model Name/Number Oral HIV Self-Test (OraQuick, US FDA Version)

ORAQUICK IN-HOME HIV TEST (US FDA Version) Product Specifications

Equipment Type In-Home HIV Test Kit
Use Detection of HIV-1 and HIV-2 Antibodies from oral fluid
Storage Instructions Store at 36F80F (2C27C), avoid direct sunlight
Condition New
Accuracy Sensitivity ~92%, Specificity ~99.98%
Technology Antibody Lateral Flow Assay
Features Simple, non-invasive, private, fast results, FDA approved
Instruments Type Rapid Oral Fluid Diagnostic Test
Display Type Visual line readout (no digital screen)
Wall Mounted No
Operating Type Manual, Self-Test
Function Screening for HIV infection
Shelf Life 18-24 months (from date of manufacture)
Portable Yes
Dimension (L*W*H) Kit dimensions approximately 20 x 12 x 3 cm
Weight Approx. 120 grams per kit
Usage Type Single Use
Real-Time Operation Yes (Results in 20-40 minutes)
Noise Level Silent
Material Plastic, Absorbent Pad, Reagent Housing
Frequency Single use only
Color White (test device)
Measurement Range Qualitative (Positive/Negative) detection of HIV-1/2 antibodies

Packaging Type Sealed box with tamper-evident components
Package Contents Test device, Developer solution vial, Test stand, Instruction booklet, Disposal bag
Time to Results 20 to 40 minutes
Intended User Adults and adolescents (age 17+) for at-home self-testing
Sample Type Oral fluid (mouth swab)
Result Interpretation One line = Negative, Two lines = Positive (requires confirmatory test)
Model Name/Number Oral HIV Self-Test (OraQuick, US FDA Version)

ORAQUICK IN-HOME HIV TEST (US FDA Version) Trade Information

Supply Ability 100 Unit Per Day
Delivery Time 1-7 Days

Product Description

Brand	OraSure Technologies
Sample Type	Oral Fluid
Pack Size	1N
CAT No	1001-0600
Model	US Version.

The OraQuick In-Home HIV Test is the first and only oral fluid rapid over the counter (OTC) HIV test approved in the U.S. It can detect antibodies to both HIV 1 and HIV 2 with an oral swab, providing a confidential in home testing option with results in as little as 20 minutes. The test kit comes with extensive resources and support, including access to a "live" toll free customer support center and comprehensive consumer website.

How OraQuick Works

OraQuick uses antibody lateral flow assay technology to detect HIV-1 and HIV-2 antibodies from an oral fluid sample. The test involves gently swabbing your gums and placing the sample in the developer solution. Results are displayed visually in 20 to 40 minutes with clear line indicators for positive or negative findings.

Benefits of At-Home HIV Testing

With OraQuick, testing for HIV is both convenient and discreet. The kit allows for private testing at home, eliminating the need for blood samples, and provides rapid results within half an hour. Its high specificity ensures trustworthy results, and FDA approval guarantees product quality and reliability.

Simple and Secure Testing Process

Designed for single use, the OraQuick kit contains all necessary components, including a test stand and disposal bag, in tamper-evident packaging. The clear instruction booklet guides users through each step, ensuring safety and accuracy throughout the process.

FAQ's of ORAQUICK IN-HOME HIV TEST (US FDA Version):

Q: How do I use the OraQuick In-Home HIV Test correctly?

A: Start by opening the sealed box and reading the instruction booklet thoroughly. Collect an oral fluid sample by swabbing your upper and lower gums, then place the swab into the developer solution. Set the device on the stand and wait 20-40 minutes for your result to appear.

Q: What does a positive or negative OraQuick result mean?

A: One line on the test device means your result is negative. Two lines indicate a positive result, which requires a confirmatory test from a healthcare professional to verify HIV infection. This is a screening tool and not a definitive diagnostic test.

Q: When should I use the OraQuick test?

A: The test is appropriate when you want a private, rapid screen for HIV at home-whether you believe you may have been exposed to HIV, want to test for peace of mind, or in routine self-checking. Remember, the kit detects antibodies, which may take weeks to develop after exposure.

Q: Where should OraQuick kits be stored before use?

A: Store the kit in a cool, dry place between 36F-80F (2C-27C) and avoid placing it in direct sunlight. Always check the expiry date and packaging integrity before use to ensure accuracy.

Q: What are the benefits of using OraQuick compared to blood-based tests?

A: OraQuick requires no blood sample and is completely non-invasive, providing results in the privacy of your own home. The oral swab method makes the process simple, painless, and less intimidating for users preferring an alternative to traditional blood tests.

Q: Is it possible to reuse the OraQuick test?

A: No, the OraQuick In-Home HIV Test is designed for single use only. For accurate results, a new kit must be used for each test. Reusing the device will compromise test integrity and validity.

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