ONE STEP PSA TEST
· Result is available in 15minutes
· Store at room temperature
· High performance with sensitivity of 97.1％ and specificity of 99.2％
· Reliable with CE certificate
INTENDED USE
Wondfo One Step Prostate Specific Antigen (PSA) Serum/Plasma Test Cassette is a rapid immunoassay designed for the qualitative determination of human prostate specific antigen in serum/plasma. The test is intended as an aid in monitoring patients for prostate disease progression or the response to therapy or for the detection of recurrent or residual disease.
For in vitro diagnostic use only. For healthcare professional use only.
STORAGE AND STABILITY
1. Store at 4 ºC ~ 30 ºC in the sealed pouch up to the expiration date.
2. Keep away from sunlight, moisture and heat.
3. DO NOT FREEZE.
SPECIMEN PREPARATION
1. Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used.
2. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2°C ~ 8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C.
3. Bring specimens to room temperature before testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
SPECIFICATION
| Description | |||||
| Cat. No. | Test Item | Format | Specimen | Sensitivity | Qualification |
| W31-S | PSA | Strip | Whole Blood/Serum/Plasma | 4 ng/mL | CE |
| W31-C | PSA | Cassette | Whole Blood/Serum/Plasma | 4 ng/mL | CE |