Panbio HIV Self Test, rapid blood home test for detecting HIV-1 and HIV-2 antibodies, 1 piece
HIV Home test Panbio HIV Self Test
The Panbio Hiv Self Test medical device is a single-use, rapid immunological test for the qualitative detection of antibodies against HIV-1 and HIV-2.
The test material is a blood sample taken from a finger. The test is intended for self-administration at home and does not require specialized training.
Facilitates the diagnosis of HIV-1 and HIV-2 infection while maintaining privacy and discretion.
Panbio Hiv Self Test ensures very high accuracy of the obtained results of 99.9-100%.
It is higher than in the case of tests in which the tested material are samples taken from the oral cavity or urine.
The test for detecting HIV-1 and HIV-2 antibodies provides results within 15-20 minutes. It is easy to use and its instructions for use are intuitive and simplified.
How does the Panbio HIV Self Test work?
The HIV virus is transmitted through sexual contact, with infected blood, certain body fluids or tissues, and from mother to child during pregnancy.
It is believed to be the pathogen that causes AIDS (acquired immunodeficiency syndrome ) .
The Panbio test detects the presence of HIV-1 and HIV-2 antibodies in the blood. To perform it, it is necessary to take 2 drops of blood from the fingertip.
One drop is then transferred to a well in the test cassette, where one drop of buffer is added sequentially.
After 15-20 minutes, the test results are visually presented as lines in the control (C) and test (T) areas.
The T line area is covered with HIV-1 antigens (glycoprotein 41) and HIV-2 antigens (glycoprotein 36).
Thanks to this, a red line in the test area becomes visible when the sample contains antibodies to HIV-1 or HIV-2.
Application
A test for detecting antibodies against HIV-1 and HIV-2 in a blood sample taken from a fingerstick.
A discreet, private test to be performed at home.
How to use
Preparation
Prepare a timer and a tissue.
Open the package and place all items on a clean, flat surface.
Wash your hands in warm water and dry them.
Choose your middle or ring finger (preferably your non-dominant hand).
Blood donation
Improve blood circulation by massaging and rubbing your hand and the previously selected finger.
Clean your finger with an alcohol wipe and let it dry (about 10 seconds).
Remove the lancing device cover.
Press the lancing device against your finger until you hear a click.
Massage your finger from the base to the tip and let 2 drops flow into the reservoir.
If you have difficulty, wipe your finger clean and squeeze again.
Wipe your finger with an alcohol wipe.
Apply a plaster to the puncture site.
If necessary, hold down to stop the bleeding.
Performing the test
The test should be performed immediately after blood collection.
Squeeze the top of the sample dropper.
Immerse the dropper in the blood contained in the reservoir.
Slowly release the pressure to draw blood into the dropper.
Place the dropper over the well.
Squeeze the top of the dropper to dispense 1 drop into the well of the test plate.
Hold the buffer bottle in an upright position and apply 1 drop of buffer into the well.
Start the timer for 15 minutes.
Read the result after 15-20 minutes.
Do not read the result later than after 20 minutes.
Reading the result
Non-reactive result (= negative)
Only 1 line visible in area C (control).
There is no visible line in the T (test) area.
The test did not detect the presence of HIV, but recent exposure cannot be ruled out.
It is recommended to repeat the test 6 weeks after the last risk of HIV exposure.
Reactive result (=positive)
There is 1 line visible in area C (control) and 1 line in area T (test).
The intensity of the lines in the T area does not matter.
A positive result indicates the possibility of HIV infection.
The result must be confirmed by a laboratory test.
Consult your healthcare professional and avoid activities that may expose others to HIV.
Test failed (=invalid)
No line is visible in the control area (C).
In the test area (T), the line may or may not be visible.
Retest with a new kit or consult your healthcare professional.
Utilization
Place all used test components in a waste bag.
Close it tightly and throw the bag with its contents into the trash bin.
Blood can transmit infectious diseases. Clean up spills and dispose of according to local regulations.
Product features
for detecting HIV-1 and HIV-2 antibodies,
to do it yourself at home,
discreet and private,
accurate (99.9-100%),
fast (result within 15-20 minutes),
from a blood sample taken from a finger,
easy to use.
Technical Specifications
professional conditions (skilled users):
sensitivity: 100%,
specificity: 99.9%,
non-professional users:
sensitivity: 99.6%,
sensitivity: 95.1%.
Important tips
The Panbio HIV Self Test should be stored at 2-30°C until the expiry date.
Do not freeze the medical device.
Do not use the test after the expiration date printed on the test bag.
Until you are ready to perform the test, do not open the sealed foil test bag.
Use the test plate within 1 hour after opening the pouch.
The buffer is intended for single use. It must be used within 1 hour of removing the cap.
The test for detecting HIV-1 and HIV-2 antibodies is intended for use with a blood sample taken from a fingerstick. No other body fluids may be used.
A negative (non-reactive) result does not completely exclude the possibility of HIV infection.
A positive (reactive) result must be confirmed by a healthcare professional using appropriate confirmatory tests.
The intensity of the test line (T) for a positive (reactive) result does not reflect the amount of anti-HIV antibodies in the collected blood sample.
False results may occur, although this is rare. If you are concerned that your test result may be false, please contact your healthcare professional.
Biotin concentrations up to 1500 ng/ml may reduce the intensity of the control line . They do not affect the operation of internal control.
Reasons for an incorrect (false) non-reactive (negative) result may be:
not following the instructions for use exactly,
use of anti-HIV treatment,
fresh infection,
presence of bubbles during sample application (especially in samples with a low positive value).
Reasons for an incorrect (false) reactive (positive) result may be:
incorrect test result reading,
not following the instructions for use exactly,
taking the HIV vaccine,
cytomegalovirus infection.
Warnings
Do not use the Panbio HIV Self Test if:
antiretroviral treatment (ARV),
coagulation disorders,
fear of needles,
damage to the bag or set elements,
previous use of the kit or its components.
Do not eat or drink while taking the test.
Before performing the test, read the instructions for use.
The Panbio HIV Self Test may give an unexpected positive result. Regardless of whether the result is positive or negative, you should consult your doctor before making a medical decision.
The medical device is intended only for in vitro diagnostics.
Only perform the test using a fresh blood sample. Do not use with a serum or plasma sample.
Use the test plate at room temperature (15-30°C).
The lancing device and sample dropper are for single use only. Don’t reuse them.
If you do not understand the instructions for use, please contact the technical service using the contact details provided.
If the test is working, a line will be visible in the control line area of the test plate. If no line is visible in the control line area, the test has failed and the result is invalid. However, the presence of a line in the control line area does not confirm that a sufficient amount of sample has been applied. Before adding buffer, transfer exactly 1 drop of blood to the well.
Keep the medical device out of the reach of children.
The buffer contains 0.09% sodium azide (as a preservative), which may be toxic if ingested. If your eyes get dirty, rinse them with running water for at least 15 minutes. If irritation persists, seek medical attention.
If the finger is still bleeding, use a tissue or gauze. Protect yourself and others.
Blood from a finger prick should be transferred from the reservoir to the well immediately to avoid blood clotting (within 2 minutes).
The medical device is not intended to detect HIV-1 and HIV-2 antibodies in infants and children under 18 months.
Panbio HIV Self Test is not intended for screening blood donors for HIV.
Contents of the package
What does Panbio HIV Self Test contain?
1 x test board,
1 x sample dropper,
1 x buffer,
1 x lancing device,
1 x patch,
2 x alcohol wipes,
1 x waste bag,
3 x instructions for use.
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