Wholesale Urine Pregnancy (HCG) Test Kits

• Type: IVD Reagent
• Assay Time: 5-10 Minutes
• Accutacy: 99%
• Shelf Life: 24 Months
• Storage Temperature: 2-30 Degree
• Certificate: CE
• Model NO.: HHCG001
• OEM/ODM: Support
• Transport Package: Carton
• Specification: 20Tests/Kit
• Trademark: IMINUO
• Origin: Hangzhou
• HS Code: 3822120000
• Production Capacity: 5000000PCS/Year

Product Description

Wholesale Urine Pregnancy (hCG) Test Kits

Detection time	5 to 10 minutes
Specime	human urine specimens
Storage	2 to 30 degree centigrade
Shelf life	24 months
Package	Individually packed test devices Package insert Disposable pipettes
Advantages	1) Good sensitivity and specificity 2) Strong R&D and technical support 3) Stable performance.  4) Friendly to end users

INTENDED USE

The Pregnancy(hCG) Rapid Test is a rapid chromato graphic immunoassay for the qualitative detection of human chorionic gonadotropin inhuman urine specimen.This kit is intended for use as an aid in the early detection of pregnancy.
Assay Time:  5-10 minutes

Relative Sensitivity: >99.99% (95%CI: 97.18%~100.00%)  

Relative Specificity: >99.99% (95%CI:97.86%~100.00%) 

Accuracy: >99.99% (95%CI:98.77%~100.00%)

PRINCIPLE

The Pregnancy (hCG) Rapid Test detects human chorionic gonadotropin through visual interpretation of color development in the internal strip. Anti-hCG antibodies are immobilized on the test region of the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti-hCG antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient hCG in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

COMPONENTS

TEST PROCEDURE

 

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

1.Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2.Add 3 drops of specimen (approximately 120 µL) directly into the specimen well (S) and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the result area in the center of the device.
3.Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

NOTE: Low hCG concentrations may produce very weak T lines after a prolonged period of time. Therefore, do not interpret the result after 10 minutes.
 

 

INTERPRETATION OF RESULTS

COMPANY INTRODUCTION

Hangzhou Immuno Biotech Co.,Ltd is the original organization in Immuno Group. The team of Hangzhou Immuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage. Gradually, IMMUNO was well known as a good R&D partner and good supplier of veterinary rapid test products. With great patience and continuous investment in design and development of IVD relative reagents and test kits, we got several encouraging achievements in the past year, especially in veterinary diagnostic field.

Immunobio is providing all the products strictly following with quality management system. We are running the ISO9001 and ISO13485 quality control system to ensure the good quality of our products, and also the Intellectual Property Management system to protect the intellectual properties of both our clients and ourselves. Immunobio is supplying its recombinant proteins, such as recombinant N protein, S protein, to our esteemed rapid test partners. Immunobio is also supplying uncut sheet format semi-product to our global partners. Immunobio is also providing rapid tests and OEM/private label services to our customers from every corner of the world.