Medical rapid Pregnancy in vitro diagnostic test Cassette (hCG Urine fertility test /ISO 13485 certified)

Pregnancy Test (hCG fertility test) 1.We are manufacturer 2.High quality but Low price 3.OEM is accepted 4.Supply other test SPECIFICATIONS                                                                                                                                                                                  Name: Good Pregnancy rapid  test strip (hCG Urine medical diagnostic  test /ISO 13485 certified)Principle: sandwich method based rapid immunochromatographic assaySpecimen: UrineTesting Time: 5 minutesStorage Temperature: 2-30 CShelf Life: 2 years.Packing Size: As per requestINTERPRETATIONSNEGATIVE: Only one band appears in the control region (C)POSITIVE: Two bands appear individually in the control region (C) and test region (T).INVALID: Control band fails to appear.CLINICAL DATA

Method		Other hCG Rapid Test		Total Results
BETEST Pregnancy Test Cassette	Results	Positive	Negative
	Positive	168	0	168
	Negative	0	211	211
Total Results		168	211	379

Sensitivity: 100% (95%-100%)*

Specificity: 100% (95%-100%)*

Accuracy: 100% (98%-100%)*

* 95% Confidence Intervals

How to distinguish a good Pregnancy test?Technical data: Accuracy>99% for pregnancy test.  For other use (other test), the requirement and accepted criterion is usually different.Pouch sealing: tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.Flow speed: The shorter the better?? NO!!  The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. 5 to 10 minutes was considered as the optimal result reading period.Background:  Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice.Why BETAI Bio does not suggest to choose the lowest price Pregnancy test? 

The cost of a rapid test usually consisted with the following 5 main aspects. 

NC membrane.  Good quality, $0.010-$0.017/4mm strip.Antibodies.  Different in different suppliers, for different items. 5usd/mg to 1000usd/mg.cassette.  Good/stable quality  $0.02-0.04/cassettelabor cost.   Increasing day by day.Tax.  17% of the selling price.From the above data we can see, no company could fulfil all the above aspects to down the price unrestrained. Considered the cost, the giant company should have advantages to down the price of NC membrane (etc.) with big order quantity. How can a small company decrease the price to be an unbelievable level?  The only answer is the quality decreasing!  BETAI Bio expects long term partners, instead of supplying one-time deal with fake products. Please feel free to contact us via email, telephone or other way. We are ready for your request.

Medical rapid Pregnancy in vitro diagnostic test Cassette (hCG Urine fertility test /ISO 13485 certified)