Revision 21_Sep_2015
40
User Guide Version 2.60 I-button WHO 5th
APPENDIX 9: Treating Viscous Samples
PRODUCT INSERT
INTRODUCTION AND INTENDED USE
The QwikCheck
TM
Liquefaction Kit can be used to accelerate the liquefaction of viscous semen
samples that remain viscous thirty minutes after collection. High viscosity can impact the accurate
measurement of motility and concentration. Use QwikCheck
TM
Liquefaction to prepare viscous
semen samples for automated or manual semen analysis. For in-vitro use only.
KIT CONTENTS
20 single dose, 5 mg vials of lyophilized
α
-Chymotrypsin and a product insert.
STABILITY AND STORAGE CONDITIONS
The product has a one year shelf life. Note the expiration date on the box and vials.
Vials can be stored at room temperature.
INSTRUCTIONS FOR USE
1.
Select one vial of
α
-Chymotrypsin.
2.
Tap the vial to move the contents to the bottom of the vial prior to opening.
3.
Add the entire contents of one vial to a viscous semen sample.
4.
Gently mix the sample to dissolve the powder.
5.
Once the sample has liquefied (5-10 minutes), immediately perform automated testing or
neutralize the enzymatic activity (optional) by adding of Human Serum Albumin (HSA) (not
provided in this kit).
CLINICAL PERFORMANCE: Semen Samples Treated with QwikCheck Liquefaction:
Parameter:
Correlation Coefficients:
Semen samples Treated
with Chymotrypsin vs. Non-
treated semen samples
Conclusions:
Test results demonstrated high
correlations for Concentration, Total
Motility, Progressive Motility and
Morphology between the treated
with chymotrypsin (QwikCheck
Liquefaction Kit) and non-treated
semen samples when run on the
SQA-V.
No detrimental effect is seen when
treating semen samples with
QwikCheck™ Liquefaction kit
containing 5 mg chymotrypsin.
Concentration
R = 0.98
Total Motility
R = 0.99
Progressive
Motility
R = 0.99
Morphology
R = 0.95
PRECAUTIONS AND WARNINGS
Each vial contains
α
-Chymotrypsin, a protease. This protease can cause irritation to eyes,
respiratory system or skin. In case of contact with eyes, rinse immediately with water and seek
medical attention. Observe the following preautions when handling the product:
Wear suitable protective clothing: Mask, gloves and laboratory coat.
Avoid dispersing material over the working area.
REFERENCES:
WHO Laboratory Manual for the Examination of Human Semen and Sperm-
Cervical Mucus Interaction, 5
th
Edition, Cambridge University Press, 2012.
