Pregnancy Test Kit

Features:

• Negative: Only one color band appears on the control region.


• Positive: Distinct color bands appear on test and control regions. Both lines indicate positive result


• Invalid: No visible band at all. Repeat the test with new test kit


• Intended use: For qualitative detection of HCG (Human chorionic gonadotropin) in urine as aid in early detection of pregnancy.


• Clinical importance: Early detection of HCG in urine indicates Pregnancy and it help in pregnancy


• management.


• Test principle: Test is based upon immune chromatography principle. Gold conjugate and Test


• line of membrane is coated with anti HCG. Sample containing HCG reacts with


• gold conjugate and makes an immune complex. This complex moves laterally and


• captured by testline proteins. Appearance of pink / purple line at "T" indicates for the presenceHCG.


• Kit Presentation : Individually packed device in a sealed poly laminated pouches along with


• disposable plastic dropper and indicative desiccant.


• Kit components : Test Devices, sample dropper & Product insert


• Specimen of choice: Urine (First morning urine is preferred as it contains high level of HCG as


• comapred to any time urine).


• Positive indication : Appearance of two pink / purple lines, one at 'T' and other at 'C'.


• Negative indication : Appearance of only one pink / purple line at 'C'.


• Inconclusive / Invalid : If No pink / purple line appeared at 'C'.


• Sensitivity : 25 mlU HCG per ml urine (able to detect on 1st day of missed MC)


• Specificity : 100% No cross reaction with other hormones


• Limitations : Refer product insert