INTRODUCTION

The One Step PSA Test is a chromatographic immunoassay in-vitro diagnostic test for the qualitative detection of Prostate Specific Antigen (PSA) tumor markers in human serum specimen. PSA tumor marker tests are based on the principle of sandwich immunossay for determination of PSA in human serum specimen.Two monoclonal antibodies are employed to identify cancer PSA specifically.

The prostate specific antigen (PSA) is the most commonly tested Tumor marker for the prostate gland discase diagnosis. PSA tumor marker is normally present in low levels in the blood of all adult men. In human blood, the normal concentration range of this biomarker is 0.0 to 4.0 ng/ml, which are variable among different human races (refer to the table at the end of this page). But when prostate specific antigen rise beyond the normal range, it can be taken as a signal of prostate gland cancer or other problems. That is why PSA becomes the subject of PSA serum detection devices.

SPECIMEN COLLECTION

For serum, collect blood into a container without anticoagulant.  Allow the blood to clot and separate the serum from the clot.  Use the serum for testing.

If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer.  Bring the specimens to room temperature before testing.  Do not freeze and thaw the specimen repeatedly.

TEST PROCEDURE

1,When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.

2,Draw 0.2ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.

3,Wait 10-15 minutes and read result.  Do not read results after 15 minutes.

INTERPRETATION OF RESULTS

Negative:  Only one colored band appears on the control (C) region.  No apparent band on the test (T) region.

Positive:  In addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region.  Please consult your physician to perform a much more detailed exam.

Invalid:  A total absence of color in both regions is an indication of procedure error and/or the test reagent has been deteriorated.

STORAGE AND STABILITY

The test kit should be stored at room temperature (18 to 30°C) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTION:

1,Must use fresh specimen and avoid repetitive freezing, the result will be invalid

2,Use it before expiry date.

3,The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.

4,Old Serum can not be used. If the serum is thick, it can be used only after being separated.

LIMITATIONS

The test is for in-vitro diagnostic use only.

 

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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