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Test Instructions HSV2

Posted by Sandra 23/10/2016 0 Comment(s) Test Instructions,

Genital Herpes (HSV2), Whole Blood-Based (Tri-line) Test Cassette Manual

home screening test for Herpes HSV2 virus in whole-blood sample.

 

 

  • One individual sealed pouch containing
  • Test device
  • Alcohol pad
  • Instructions

 

 

Material Required but not provided

  • Time or Watch capable of timing 10 to 30 minutes
  • Clean, Disposable, Absorbent Workspace Cover
  •  Biohazard Wast Container

 

PRECAUTIONS

  • Carefully follow the instructions exactly.
  • Only use the included pipette.
  • This kit is for in vitro use only. Do not swallow.
  • Contaminated blood may cause erroneous results.
  • Discard after first use. The test can only be used once.
  • Do not use test kit beyond the expiration date.
  • Do not use the kit if the pouch is punctured or not well sealed.
  • Keep out of children's reach.

 

STORAGE AND STABILITY

  • Store at 4°C to 30°C in the sealed pouch up to expiration date.
  •  Keep away from sunlight, moisture and heat.
  •  Use the test shortly after opening the pouch.
  •  Do not freeze.

 

TEST PROCEDURE

  • When the test have been stored in a cold room, wait for it to reach room temperature (10°C - 30°C).
  • Wash the hands thoroughly to avoid contamination of the specimen.
  • Open the pouch and place the cassette on a level surface.
  • Clean the area to be lanced with the alcohol pad.
  • Wait for the area to dry completely (do not blow on it).
  •  Use the safety lancet and pipette. The safety lancet can only be used once.
     

 

Twist off the protective cap, and then pull it straight out.

 

 

 

 

 

 

Press the lancet firmly against the puncture site to activate the device.

 

 

 

 

 

 

Gently apply intermittent pressure near the puncture site to obtain the required blood volume

 

 

 

 

 

  • Squeeze the pipette together and collect blood by slowly releasing the pressure.
  • Add 2 - 3 drops of blood, from the pipette, to the round well of the cassette.(Region 1 and 2)

 

 

HOW TO INTERPRET THE RESULT

 

Read the result 15 minutes after adding the blood sample. Do not read the result after 20 minutes.

 

HSV-2 Antibodies Present (positive):

 

Colored lines are visible in the control region IgM and / or IgG test region, this means you have a herpes-2 infection, genital herpes is a sexually transmitted infection. It causes small, painful, fluid-filled blisters. These blisters break open and leave an indented sore or ulcer. The blisters can be found on the genitals, buttocks, or thighs. However, they can also spread to other parts of the body (such as, the mouth, face, or eyes).

 

If you have a positive herpes IgM result with a negative herpes IgG result, mean you were recently infected with herpes, this is because herpes IgM antibodies,and IgM antibodies generally, are thought to peak shortly after an initial  infection and then recede.

 

One colored line is visible in the control region and no colored line in the test region. This means with high accuracy that you are not infected with herpes simples HSV-2 virus.

 

However, even herpes IgM antibodies can take up to ten days to develop after primary infection with the virus. If you believe you have been exposed, but have no symptoms, you should therefore wait at least two weeks before getting tested, you may also want to go for a repeat test after 6 months if you do not undergo regular screening.

 

Negative (No HSV2 infection):
One colored line is visible in the control region and no colored line in the test region. This means that no Herpes HSV2 infection was detected.

 

Invalid:
There are no colored lines or only a colored line in the test region. The most common reason for an invalid test result is that the test procedure was not carried out properly.