One Step Hepatitis C Virus Whole Blood Serum Plasma Rapid Test Kits

Product Description
One Step HCV Whole Blood / Serum/Plasma Rapid Test Kits

HCV Rapid Test Kit adopts immunochromatographic sandwich method for the qualitative detection of antibody to Hepatitis C Virus in human whole blood, serum or plasma.



CE MARKING, GOOD WORLDWIDE MARKET


Product Name
HCV Rapid Test Kits

Specimen
Serum/Plasma, Whole blood
Sensitivity
Custom
Format
Cassette
Width
4.0mm
Application
Detection of antibody to Hepatitis C Virus in human whole blood, serum or plasma
Usuage
Professional use or Self testing




Characteristic

Reliable: High sensitivity and specificity
Visual: Clear background, result won't change for a long time
Quick: Get results in 15 minutes
Easy: Suitable for professional use and point–of-care testing
Flexible: Specimen can be whole blood ,serum or plasma
Storage
Store in room temperature
Shelf Life
24 months
Certificate
ISO13485/ ISO9001
Packing
1 test/pouch, 25 tests with one insert per box
Production time
25 days after order /confirm/ied
Delivery
By ship/ Airplane/ Express
Sample
7 days free samples provided
Service
OEM service acceptable
Detailed Images
Performance:
Comparison between our HCV Hepatitis C Rapid Test Kit and HCV-RNA PCR method testing 310 specimens


Method


Total
Positive
Negative
Indeterminate


HCV-RNA PCR Method
Positive
58
1
1
60
Negative
2
238
2
242
Invalid
2
3
3
8
Total
62
242
6
310
Sensitivity of our HCV Test is 58/60*100%=96.7%
Specificity of our HCV Test is 238/242*100%=98.3%
Conformity rate with HCV-RNA PCR Method is 296/310*100%=95.5%
Conformity Rate of our device and the reference ELISA Test

Results showed that there was good conformity between our HCV Rapid Test Kits and the reference ELISA Test

HCV Positive Samples(n=104)
HCV Negative Samples(n=162)
Postive Conformity
Negative Conformity
Total Conformity

+
-
+
-
ELISA Test
104
0
1
161
100%
99.38%
99.69%
Our HCV Test kits
104

0
2
160
100%
98.8%
99.3%
How to use the HCV Rapid Test Kits?
See Below
How to read the results?
Read all the information in the enclosed instruction leaflet before use the test.

Negative: only one pink band appears on test region of the cassette. This indicates that there is no detectable HCV in the whole blood.

Positive: Two pink bands appear on test region of the cassette. This indicates that the specimen contains detectable amount of HCV.
Invalid:If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.


Precaution:
1. The test is for in-vitro diagnostic use only.
2. The test is qualitative filter detection, it can not be used as the final test for blood donor.
3. Must use fresh specimen.
4. Use it before expiry date.
5. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator Limitations.
6. The test kit should be kept away from direct sunlight, moisture and heat.
Packing & Delivery
Packing:
1) Individual packing, 1 test/pouch.
2) Packed in bulk with Polybag.
3) According to customer's requirements.

Delivery:
1) By Ship/ airplane/ Express according to different quantity.
2) According to customer's requirements.

Certifications

US FDA Clearance, CE Marking, Good Worldwide Market


Our Company
Advantage:

1) Custom manufacturing of quality medical products and biochemical reagents.
2) Obtained ISO 9001 certificate,GMP approval,FDA approval and CE Mark already.
3) More than 30% of the employed staff have obtained master and doctor degree from prestigious worldwide institutions.
4) More than 30,000 square feet of laboratory space.
5) Immunogold Labeling Techniques.
6) Superb quality products with very affordable prices.
7) Provide prompt and effective after-sale service, ensure the customer no any risk on our products.

Our Service
Our company also provide range of service as below:
* Professional sourcing.
* Purchase agent to contract with your chinese suppliers to protect your benefit.
* Quality control.
* Shipping line booking.
* Custom clearance assist.
* Factory tour arrangement when customers visit China.
We have a professional team with many years of Export and import experience.



Related Products
FAQ
We want to give you best price and service, please let us know more details as follows:
1. Which specimen do you need?

----Serum/Plasma or Whole blood.


2. Do you need OEM packing?

---- Let us know details about your packing.
3.How many do you want to buy?



4. EXW price or FOB Price or CIF(please give me your destination)?
Thanks for your interested in our products, any question please do feel free to contact us: 86-18917377467 Michi