One Step HCG Pregnancy Test Kit Home Blood Rapid Test Cassette for Urine/Serum

• Type:Medical Incubator
• Name:One Step HCG Pregnancy Test Kit Home Blood Rapid Test Cassette
• Specimen:Urine/Serum/Plasma
• Format:Cassette
• Size:3.0mm, 4.0mm
• Accuracy:over 99.9%
• Read results:in 5-10 minutes
• Methodology:Colloidal gold
• Shelf time:2 years
• Power Source:Manual
• Warranty:1 Year
• After-sale Service:Onsite Training
• Material:Plastic
• Shelf Life:2 years
• Quality Certification:ce
• Instrument classification:Class II
• Safety standard:EN 149 -2001+A1-2009
• Place of Origin:CN;FUJ
• Model Number:HCG
• Brand Name:Wiz or Baysen, OEM

One Step HCG Pregnancy Test Kit Home Blood Rapid Test Cassette for Urine/Serum

HCG Pregnancy Test Cassette (Urine/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine or serum specimen to aid in the early detection of pregnancy by both professional and home users.

Features:

• Read time in 5-10 minutes
• High accuracy over 99.9%
• Sensitivity over 99.9%
• Specificity over 99.9%

PRINCIPLE

This product is composed of the glass fiber strips of the monoclonal antibody against human chorionic gonadotropin (hCG), anti-mouse IgG solid cellulose nitrate membrane and the bonders of absorptive colloidal gold - a monoclonal antibody against hCG. It adopts the principles of double antibody sandwich method and immunochromatography to test the hCG in the urine and serum.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.
2. One piece of operating instruction. 

WARNING AND PRECAUTIONS

1. For in vitro diagnostic uses only.
2. All patient samples should be treated as if capable of transmitting diseases.
3. Do not interchange reagents from different lots or use test kit beyond the expiration date.
4. Icteric, lipemic, hemolysis, heat treated and contaminated sera may cause erroneous results.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).

SAMPLE COLLECTION AND PREPARATION

Plasma

1. Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by venipuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. The plasma may be frozen at -20°C for up to one year. 

Serum

1. Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by venipuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.

ASSAY PROCEDURE

Serum or Plasma Sample

Add 70-100ul or 2-3 drops of serum or plasma into the sample well. Observe the result in 5-10 minutes.

INTERPRETATION OF RESULTS

1. Negative: No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that you are not pregnant.
2. Positive: In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that you are pregnant.
3. Invalid: If no band appears in the control region (C), regardless of the presence or absence of a line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.