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Prostate Specific Antigen PSA Rapid Test Kits Rapid Drug Test Kits

Product Details:

Place of Origin:CHINA
Brand Name:Novatrend
Certification:CE, ISO13485
Model Number:FI-PSA-302

Payment & Shipping Terms:

Minimum Order Quantity:500
Packaging Details:10T/kit
Supply Ability:100 Million a year
Detailed Product Description
Format: Cassette Specimen: Serum /Plasma
Kit Size: 10T/25T Test Range: 2~100 Ng/mL
Storage: 2-30℃ Certificate: CE

 

A rapid test for the qualitative detection of Prostate Specific Antigen (PSA) in whole blood, serum or plasma. CE certified

 

 

Applications: 

 

The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Cassette (Whole Blood /Serum /Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of Prostate Specific Antigen in whole blood, serum or plasma.

 

Description: 

 

Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a single chain glycoprotein with a molecular weight of approximate 34 kDa.1 PSA exists in three major forms circulating in the serum. These forms are free PSA, PSA bound to α1 – Antichymotrypsin (PSA-ACT) and PSA complexed with α2–macroglobulin (PSA-MG).2

PSA has been detected in various tissues of the male urogenital system but only prostate glandular and endothelial cells secrete it. The PSA level in serum of healthy men is between 0.1 ng/mL and 2.6 ng/mL. It can be elevated in malignant conditions such as prostate cancer, and in benign condition such as benign prostatic hyperplasia and prostatitis. A PSA level of 3 to 10ng/ml is considered to be in the “gray-zone” and levels above 10ng/ml are highly indicative of cancer.3 Patients with PSA values between 3-10ng/ml should undergo further analysis of the prostate by biopsy.

The prostate specific antigen test is the most valuable tool available for the diagnosis of early prostate cancer. Many studies have confirmed that the presence of PSA is the most useful and meaningful tumor marker known for prostate cancer and prostate infection of Benign Prostatic Hyperplasia (BPH).4

The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Device (Whole blood /Serum /Plasma) utilizes a combination of colloidal gold conjugate and anti-PSA antibodies to selectively detect total PSA in whole blood, serum or plasma. The test has a cut-off value of 3ng/ml and a reference value of 10ng/ml.

 

How to use? 

 

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.

2.  Place the cassette on a clean and level surface.

For Serum,Plasma or Venipuncture Whole Blood specimens:

·   Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40mL) or 2 drops of venipuncture whole blood (approximately 80ml) to the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40mL) and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

·   To use a capillary tube: Fill the capillary tube and transfer approximately 80mL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.

·   To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 80 mL) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.

3.  Wait for the colored line(s) to appear*. Read results at 5 minutes.  Do not interpret the result after 10 minutes.

*Note: if migration is not observed in the result window after 30 seconds, add one or two extra drops of buffer.

Prostate Specific Antigen PSA Rapid Test Kits Rapid Drug Test Kits

 

 

 
   

INTERPRETATION OF RESULTS

 

(Please refer to the illustration above)

POSITIVE:* Three distinct colored line appear.

·   A test line (T) intensity weaker than the reference line (R) indicates a PSA level between 3-10 ng/ml..

·   A test line (T) intensity equal or close to the reference line (R) indicates a PSA level of approximately 10ng/ml

 

NEGATIVE: Color lines appear in both the control (C) and reference (R) regions. No apparent colored line appears in the test line region (T). This indicates a PSA level below 3ng/ml.

 

INVALID: Control line (C) or reference line (R) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

 

QUALITY CONTROL

  • A procedural control is included in the test. The appearance of colored lines in the control line region (C) and reference line region (R) is considered a procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

    Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

Contact Details
Hangzhou AllTest Biotech CO.,LTD

Tel:86-571-56267891

Fax:86-571-56267856

Contact Person: Mrs. Selina

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