Screen Test PSA – Rapid PSA Test

Semi-quantitative rapid test for Prostate Specific Antigen PSA

Sample: whole blood, serum or plasma

Professional in vitro diagnostic use

Product description

Screen Test PSA is a rapid immunochromatographic test for the semi-quantitative detection of Prostate Specific Antigen PSA in whole blood, serum or plasma samples.

The test is intended exclusively for professional in vitro diagnostic use and is indicated as an aid in identifying PSA levels, a parameter commonly used in the clinical assessment of prostate health.

The device enables rapid result reading, with reference values useful for distinguishing PSA levels below 3 ng/mL, between 3 and 10 ng/mL, or above 10 ng/mL.

Main features

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  Semi-quantitative PSA rapid test
  


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  Usable with whole blood, serum or plasma
  


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  Result reading in 5 minutes
  


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  Do not interpret the result after 10 minutes
  


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  Cut-off value: 3 ng/mL
  


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  Reference value: 10 ng/mL
  


• 
  For professional in vitro diagnostic use only
  


• 
  Storage at room temperature or refrigerated: 2-30°C
  


• 
  Single-use test
  

Intended use

The PSA Rapid Test is a rapid chromatographic immunoassay for the semi-quantitative detection of Prostate Specific Antigen in whole blood, serum or plasma.

Test principle

The test uses a combination of anti-PSA antibodies and colloidal gold conjugate to selectively detect total PSA in the sample.

The appearance and intensity of the colored lines allow a semi-quantitative assessment of the PSA level.

Result interpretation

Negative

The lines appear in the control zone C and in the reference zone R, but the test line T does not appear.

Indicates a PSA level below 3 ng/mL.

Positive between 3 and 10 ng/mL

The test line T appears with lower intensity than the reference line R.

Positive around 10 ng/mL or higher

The test line T has the same or similar intensity as the reference line R.

Invalid result

If the control line C or the reference line R does not appear, the test is invalid and must be repeated with a new device.

Usable samples

The test can be performed with:

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  Whole blood from venipuncture
  


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  Whole blood from finger prick
  


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  Serum
  


• 
  Plasma
  

Brief instructions for use

Bring the test, sample and buffer to room temperature, between 15°C and 30°C, before use.

For serum or plasma:

add 1 drop of sample, about 40 µL, into the test well and then 1 drop of buffer.

For whole blood from venipuncture:

add 2 drops of whole blood, about 80 µL, and then 1 drop of buffer.

For whole blood from finger prick:

apply about 80 µL of blood using a capillary tube or 2 drops of blood and add 1 drop of buffer.

Read the result after 5 minutes.

Supplied materials

• 
  Test devices
  


• 
  Droppers
  


• 
  Buffer
  


• 
  Instructions leaflet
  

Materials required but not supplied

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  Sample collection containers
  


• 
  Timer
  


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  Centrifuge, if needed for serum/plasma
  


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  Lancets for finger-prick blood
  


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  Heparinized capillary tubes and dispensing bulb, if needed
  

Declared performance

The PSA Rapid Test was compared with a market-leading PSA ELISA test on clinical samples.

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  Relative sensitivity: 99.0%
  


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  Relative specificity: 99.2%
  


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  Overall accuracy: 99.1%
  

Storage

Store the kit at room temperature or refrigerated, between 2°C and 30°C.

Do not freeze.

Do not use after the expiry date indicated on the package.

Warnings

• 
  For professional in vitro diagnostic use only
  


• 
  Do not use if the package is damaged
  


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  Handle all samples as potentially infectious
  


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  Wear personal protective equipment during the test
  


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  The test must not be used as the sole criterion for diagnosing prostate cancer
  


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  Results must be interpreted by the physician together with other clinical and diagnostic data