PSA Rapid Test Uncut Sheet

INTENDED USE

The PSA gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of prostate specific antigen (PSA) in human serum/plasma or whole blood.

PRINCIPLE

PSA is a normal secretion that secreted by normal prostatic epithelial cell and malignant cancer of prostate. PSA is normal product, but when its concentration exceed over 4ng/ml, it can be taken as an index to the risk probability of prostate cancer. The prostate cancer is the most frequent malignant tumor in male; PSA is considered as the most valuable tumor maker, so the detection of high level of PSA is a specific and effective way to diagnose the prostate cancer, also an index to examine the cancer relapse and therapy monitoring.

The PSA RST is a chromatographic immunoassay (CIA) for the detection of PSA in human serum/plasma or whole blood. Specific antibody against PSA is pre-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 PSA present, a pink colored band will develop on the membrane in proportion to the amount of PSA 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 PSA.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.

2. One piece of operating instruction.

3. One bottle of whole blood chasing buffer.

SAMPLE COLLECTION AND PREPARATION

Whole Blood

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.

1. Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks.

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

Add 70-100ul or 2-3 drops of serum/plasma into the sample well.

For whole blood tests, add 1~2 drops of whole blood into the sample well and then add 1~2 drops of chasing buffer into the sample well. Observe the result in 10 –20 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 no PSA has been detected.
2. Positive: In addition to a pink colored band in the control region(C), another pink colored band will appear in the test region (T). This indicates that the specimen contains PSA.
3. Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

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 expiration date.

4.  Icteric, lipemic, hemolysed, 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 (24months).

 

Contact  Rebecca Yan 

Skype: span.biotech

Email: rebecca@spanbio.com

Tel:  +86(755)89589611

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Web:

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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