BIOSYNEX HIV rapid test

AIDS caused by Human Immunodeficiency Virus (HIV), The virus progressively destroys the immune system so that the body is unable to defend itself against illness. An HIV carrier may not have any symptoms and cannot be identified by any external features. AIDS can take 10 to 15 years to develop after the infection with HIV, most common route of transmission as following,

• Sexual：Heterosexual or homosexual
• Blood-borne：injecting drug use, contaminated blood / organ / needles
• Mother-to-child

HIV can be detected through blood tests, The World Health Organisation recommends HIV self-testing as one option to make testing more accessible. Self-testing can be especially useful for people who do not want to go to a clinic or centre for testing and prefer the convenience and privacy to do it by themselves.

Window Period

Window period is the period between the moment a person get infected with HIV and that when the antibody /antigen test shows a positive result. The window period for HIV testing is 3 months. During this period, the virus replicates rapidly in the infected person who becomes highly infectious and can transmit the virus to other people even though his HIV antibody / antigen test remains negative. A negative result still cannot exclude infection if the user has recent exposure in the previous 3 months. Suggest to purchase 2 boxes to repeat the test to achieve a more reliable test result.

**This product only available for in Hong Kong according to there are various registration requirements by different government, sorry for any inconvenience caused.**

• Sensitivity 100% / Specificity 100%
• WHO endorsed self test tools
• CE Marked (CE0123)
• Recognized by United Nations Joint Programme on AIDS (UNAIDS) as a major innovative technology in the fight against AIDS in 2019
• Introduced by AIDS hotline website (https://www.27802211.com/tc/index.php)
• 1 drop of blood sampling for the test
• Rapid test (results in 10 minutes)

Performance

HIV self test has undergone clinical assessments. A 99.9% correlation between this product and an ELISA laboratory test was observed.
A clinical study* performed in hospitals using capillary blood showed that the EXACTO® TEST HIV has a sensitivity of 100% and a specificity of 100%.
A practicability study conducted with a laymen population showed that 97.8% of participants obtained a correct and interpretable result. A readability study confirmed that 98% of the different types of results were interpreted correctly.

*HIV self test, a Finger-Stick Whole Blood HIV1/2 Exhibit a very high Sensitivity and Specificity in both HIV infected known patients and HIV negative individuals, 2016. CHR Orléans T.PRAZUCK et al.

Kit includes

• Pouch
• Cassette
• Dropper bottle
• Inverted cup
• Alcohol wipe
• Sterile pad
• Sterile lancet
• Plaster

Instructions

1. Have a watch or a timer
2. Wash your hands with soap and hot water and then dry them before proceeding to the next step
3. Take all the elements out of the box, place them on a flat and clean surface and identify each element of the kit
4. Open the pouch and remove the cassette. Use the test within 1 hour
5. Remove the alcohol wipe from its pouch and disinfect the tip of the finger chosen for blood collection
6. Remove the sterile pad from its pouch. Wipe away traces of alcohol
7. Remove the cap of the lancet
8. Apply the lancet on the fingertip. Trigger it by pressing firmly on the other end
9. Squeeze the tip of the finger to form a large drop of blood for the sampling
10. Place the flared part of the inverted cup on the drop of blood to fill the cup entirely
11. Immediately deposit the drop of blood into the square well «BLOOD» of the cassette (the drop of blood must be in direct contact with the bottom of the well).
12. Make sure that the bottom of the square well «BLOOD» is completely red before moving to the next step (this confirms that the drop of blood has been properly added)
13. Unscrew the cap of the dropper bottle. Put two drops in the round well «DILUENT» of the cassette
14. Start the timer or write down the time of deposit. Wait 10 minutes to read the result. Do not read beyond 20 minutes. During this time you can put on the plaster

*Chinese version for reference only, if there is any inconsistency or ambiguity between the original version and the Chinese version, the original version shall prevail.

Results

Positive: If presence of Test band T, and presence of the Control band C, whatever their intensities.

• A POSITIVE result must be confirmed by a laboratory test. To do so, please contact your doctor or go to a screening centre.
• Pending confirmation of your result, use condoms to protect yourself and others.

Negative: If absence of Test band T and presence only of the Control band C, whatever its intensity.

• A NEGATIVE result can appear in a person who was infected over the last three months.
• You cannot conclude to be HIV-negative if you identify a risky exposure in the 3 months preceding this HIV screening self-test.

Invalid: If the Control band C is missing: your test is NOT VALID, even if a Test band T appears. Please do another test.

Precautions

• Do not freeze. Keep in a dry place between 2°C and 30°C.
• Remove the test cassette from the sealed pouch and use it within on hour.
• Run the test in a place where the temperature is between 15°C and 30°C.
• This test should be used only from a blood sample and should be performed immediately after blood sample collection at the fingertip.
• Single use
• The bottom of the square well «BLOOD» must be completely red before adding the diluent in the round well «DILUENT».
• Keep the self-test and all components out of reach of children; ingesting the diluent may be dangerous and the lancet could potentially cause an injury.
• This test is designed for the self-screening of users who are not aware of their serological status and must not be used for the follow-up of antiretroviral  treatments (ART) of HIV-positive persons. People using PrEP may obtained false negative results when using the test. A medical follow up with regular testing is preconized in this case.
• Negative results may be obtained in people infected less than three months before the test or infected with rare HIV variants. If you think you experienced a risky exposure over the last 3 months, you must visit your General Practitioner (GP) to get a prescription for a 4th generation ELISA-test in a laboratory, or use this self-screening test at least 3 months after the last risky exposure. Over this 3-month period, use condoms to protect yourself and others.
• A positive result must absolutely be confirmed by a laboratory test. Consult your doctor.
• The diagnosis of an infection by the HIV virus can only be done by a doctor on the basis of biological tests run in a clinical laboratory.

EXACTO® TEST HIV is merely an extra tool aimed at encouraging the screening of HIV infections.

• EXACTO® TEST HIV cannot detect other infections (sexually transmitted infections or others). Erroneous results can be obtained if:
  • The instructions for use were not properly followed,
  • The aluminum pouch was damaged or the test was not run immediately after the pouch was opened,
  • Storage conditions were not respected or the test was conducted after the expiry date indicated on the aluminum pouch.

Storage

Store in a dry place at a temperature between 2°C and 30°C. Do not freeze.