AwarerHOME HIV Oral Self Test

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AwarerHOME™ HIV Oral Self Test is a single use, rapid chromatographic immunoassay for the qualitative detection of antibody to Human Immunodeficiency Virus (HIV) type-1 and/or type-2 in human oral mucosal exudate. It is intended for use in medical institutions and self-testing by lay users as an aid for the diagnosis and management of patients related to infection with HIV.

 

ISO 13485:2016 QMS certification

MDA approved IVDD2844024-163845

Made in Malaysia

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EQUAL PERFORMANCE, GREATER CONVENIENCE

Reliable Results

The AwarerHOME™ HIV Oral Self Test has an impressive diagnostic sensitivity of 99.23%, and specificity of 100.00%, with overall accuracy of 99.61%, making it a highly reliable method for HIV screening.1

Non-Invasive, Painless

The AwarerHOME™ HIV Oral Self Test is non-invasive, requiring only a simple swab of the inside of the mouth. This makes it more comfortable for patients and reduces the fear associated with needles.

Confidential, Anonymous Testing

The AwarerHOME™ HIV Oral Self Test can be used in a private setting, which encourages individuals to get tested without the fear of judgment or disclosure concerns.

No Mess or Contamination

The AwarerHOME™ HIV Oral Self Test eliminates the risk of mess or contamination associated with blood-based tests making it safer for both the person being tested and healthcare professionals.

Portable, Easy to Use

The AwarerHOME™ HIV Oral Self Test is easy to administer and doesn't require specialised medical training or equipment allowing for widespread testing in various healthcare settings.

Fast Results

The AwarerHOME™ HIV Oral Self Test provides quick results, within 15 minutes. This speed allows users to know their results and act upon it promptly, reducing fear and anxiety associated with delays in other HIV testing results.

 EXCELLENT PERFORMANCE FOR HIV ORAL TESTING

 
 

 

AwarerHOME™ HIV Oral Self Test is a 2nd generation antibody test with estimated median window period of 31 days (interquartile range 26 to 37 days), and there is about 50% chance a false negative result may occur between 26 and 37 days after exposure. By 90 days, it is able to detect more than 99% of the antibodies with 0-1% chance of false negative result.3

 

 

SIMPLICITY IN EVERY STEP

Video Instructions.

  

SPECIFICATIONS

 


CONTENTS

3 pouches meticulously labeled 1,2 & 3 for ease of use
An informative booklet with clear testing instructions and FAQs
A discreet, plain bag for hygenic disposal



References

1.    Universal Therapeutics Diagnostics Sdn Bhd. (2023). Instructions for Use: AwarerHOME™ HIV Oral Self Test.

2.    World Health Organization. HIV assays: laboratory performance and other operational characteristics: rapid diagnostic tests (combined detection of HIV-1/2 antibodies and discriminatory detection of HIV-1 and HIV-2 antibodies): report 18. 2015.

3.    Pebody, R. (2022, March). How accurate are rapid, point-of-care tests for HIV? AidsMap. https://www.aidsmap.com/about-hiv/how-accurate-are-rapid- point-care-tests-hiv


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