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One Step PSA Test is a rapid direct binding immunoassay in-vitro diagnostic (IVD) test for the qualitative detection of Prostate Specific Antigen (PSA) tumor markers in human whole blood, plasma or serum. PSA tumor marker tests are based on the principle of sandwich immunoassay for determination of PSA in human whole blood, plasma or serum.
TEST PROCEDURE:
1. Do not open foil pouch until ready to begin testing. The test cassettes should be allowed to come to room temperature (2-30°C) before opening the pouch.
2. Place the test cassette on a flat, dry surface.
For Serum or Plasma specimens: Add 1 drop of serum or plasma (about 25μl) to the Sample Well (S), then add 1 drop of buffer and start the timer.
For Whole Blood specimens: Add 2 drops of whole blood (about 50μl) to the Sample Well (S) , then add 1 drop of buffer and start the timer.
3.Read the result within 15-20 minutes. Do not read results after 20 minutes.
INTERPRETATION OF RESULTS：2. Place the test cassette on a flat, dry surface.
For Serum or Plasma specimens: Add 1 drop of serum or plasma (about 25μl) to the Sample Well (S), then add 1 drop of buffer and start the timer.
For Whole Blood specimens: Add 2 drops of whole blood (about 50μl) to the Sample Well (S) , then add 1 drop of buffer and start the timer.
3.Read the result within 15-20 minutes. Do not read results after 20 minutes.
Positive: Two red lines appear, one in the test region (T) and another one in the control region (C). The result is positive no matter the test line (T) is stronger or weaker than the control line (C).
Negative: Only one red line appears in the control region (C ) indicating the test result is negative.
Invalid: If the control line (C) fails to appear, the test result is invalid regardless of the presence or absence of the test line (T).
SPECIFICATION:
| Description | Specimen | Format | Catalog No. | Sensitivity | Package Size | Strip Width | Certificate |
| (PSA) Prostate Specific Ag Test | Serum/Plasma | Strip | E30-11 | 4ng/mL | 50 Tests | 3.0 mm | —— |
| Cassette | E30-20 | 25 Tests | 4.0 mm | ||||
| Whole Blood | E30-21 | 25 Tests | 4.0 mm |