AFP Rapid Test Uncut Sheet

INTENDED USE

The AFP Gold Rapid Screen Test (RST) is a chromatographic immunoassay for the detection of alpha fetoprotein (AFP) in human serum / plasma or whole blood.

PRINCIPLE

The AFP RST is a chromatographic immunoassay (CIA) for the detection of AFP in human serum or plasma. Specific antibody against AFP re-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with other specific antibodies. If AFP present, a pink colored band will develop on the membrane in proportion to the amount of AFP presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of AFP.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.
2. Blood diluent in a dropper bottle, stored at 2-8°C.
3. One piece of operating instruction.

WARNING AND PRECAUTIONS

1.  For in vitro diagnostic use only.

2.  Do not use after expiration date.

3.  Test device should remain sealed until use.

4.  The device stored at 4℃ should be balanced to room temperature prior to use.

5.  Desiccant in the sealed pouch, don’t eat it.

STORAGE

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

SAMPLE COLLECTION AND PREPARATION

Fingerstick Specimens (Whole Blood)

1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce it with a sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Use micropipet to obtain about 100 ul fresh blood .

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 veinpuncture.
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. 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 veinpuncture.
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 70-100 ul or 2-3 drops of serum or plasma into sample well. Observe the result in 10-20 minutes.

Whole Blood Sample

Add 1 drop of whole blood into sample well, after all blood completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 10-20 minutes.

 

Contact  Rebecca Yan 

Skype: span.biotech

Email: rebecca@spanbio.com

Tel:  +86(755)89589611

Fax: +86(755)89580096

Web:

www.spanbiotech.com

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits:
Rapid Tests for Human Use :
1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH
2) Infectious diseases: Hepatitis B, HCV, HIV
3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC
4) Tumor markers: CEA, PSA, AFP, FOB
5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia
6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc.
Rapid Tests for Veterinary :
1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test
2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus
3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
Rapid Tests for Food Safety :
1)For Antibiotics Residue : Nitrofurans (AOZ,AMOZ, AHD, SEM), Streptomycin , Sulfonamides , Chloramphenicol , Quinolone , Beta-Lactam&Tetracycline Combo (2 in 1), β-Lactams & Streptomycin & Chloramphenicol & Tetracyclines Combo (4 in 1), Beta-Lactam, Tetracycline test
2) For Beta-Agonist Residue : Ractopamine, Clenbuterol ,Salbutamol