BLOOD SCIENCES
DEPARTMENT OF CLINICAL BIOCHEMISTRY
Title of Document: BioSign® Instructions for Use
Q Pulse Reference No: BS/CB/POCT/SOPS/19
Authoriser: Francesca Mills
Version NO: 2.0
BioSign® hCG - New One Step Pregnancy Test Kit
Instructions for Use
Test Procedure
1. Label the device with the patient name.
2. Fill the dropper with the sample (without air
bubbles).
3. Holding the dropper in a vertical position, add 3
drops of sample into the sample well.
4. Read the result at 3-5 minutes. Do not interpret
the result after 5 minutes.
Interpretation of results
POSITIVE = TWO pinkish-purple lines,
one each at the Test (T) and Control (C)
position.
NEGATIVE = ONE pinkish-purple line at
the Control (C) position.
INVALID = No lines visible or a test line
only. Repeat with a new cassette.
 Any urine sample is appropriate but the first morning urine specimen is optimal for the detection of
early pregnancy. The urine should not be too dilute.
 BioSign® hCG - New One Step Pregnancy Tests have a sensitivity of 25 mIU/ml enabling detection
of hCG concentration before the day of expected menstruation.
For product queries and to order further kits
POCT Team Ext: 38380 or email POCT@nbt.nhs.uk
For more detailed instructions please refer to:
 POCT BioSign® New One Step Pregnancy Test SOP (Q Pulse Reference No: BS/CB/POCT/SOPS/21)
 Pack insert included in every box of BioSign® hCG – One Step Pregnancy Test kit.
Active date: 06/08/2014
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