Test Format: Strip/CassetteSpecimen: Serum/PlasmaExpiry date: 24 MonthsFunction: Rapid testStorage: 2-30 centigrade
CE certificate IVD Tumor Marker PSA rapid test strip Prostate Specific Ag Rapid diagnostic kit specimen serum/plasma
Intended Use of PSA Rapid Test Device
The PSA Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of prostate specific antigens in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of prostate cancer.
Principle of PSA Rapid Test Device
The PSA Rapid Test Device (Whole Blood/Serum/Plasma) detects prostate specific antigens through visual interpretation of color development on the internal strip. PSA antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with PSA antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient PSA in the specimen, a colored band will form at the test region of the membrane. A test band (T) singal weaker than the reference band (R) indicates that the PSA level in the specimen is between 4-10 ng/mL. A test band (T) signal equal or close to the reference band (R) indicates that the PSA level in the specimen is approximately 10 ng/mL. A test band (T) signal stronger than the reference band (R) indicates that the PSA level in the specimen is above 10 ng/mL. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Tumor Markers Catalog
Product
Name
Production
Information
Catalog No.
Specimen Used
Test Format
Kit Size
Sensitivity
AFP Alpha
Fetoprotein Test Strip
H171-11P
S/P
Strip
50 pcs per box
20ng/mL
AFP Alpha
Fetoprotein Test Cassette
H171-23P
S/P
Cassette
25 pcs per box
20ng/mL
CEA Carcinoma
Embryonic Ag Test Strip
H172-11P
S/P
Strip
50 pcs per box
5ng/mL
CEA Carcinoma
Embryonic Ag Test Cassette
H172-23P
S/P
Cassette
25 pcs per box
5ng/mL
FOB Fecal
Occult Blood Test Strip
H173-11F
Feces
Strip
50 pcs per box
50ng/mL
FOB Fecal
Occult Blood Test Cassette
H173-23F
Feces
Cassette
25 pcs per box
50ng/mL
PSA Prostate
Specific Ag Test Strip
H174-11P
S/P
Strip
50 pcs per box
4ng/mL
PSA Prostate
Specific Ag Test Cassette
H174-23P
S/P
Cassette
25 pcs per box
4ng/mL
AFP/CEA/PSA
test panel
H175-43P
S/P
Panel
20 pcs per box
-
Main Components
Alcohol pad, lancet, buffer, cassette, plastic straw, desiccant, instruction for use.
Test Procedure
Test Procedure
Strip: Immerse the test strip in the specimen with printed sample end pointing toward specimen for 3-5 seconds. Interface of urine do not exceed the marked line.
Cassette: Take off outer packing, using a pipette vertically drop 2 drops (about 100ul) specimen into the specimen well.
Interpretation of Result
Positive: Two red lines appear in the test area (T) and the control area (C).
Negative: Only a red line appears in the control line (C). There is no red band in the test area (T).
Invalid: Quality control area (C) does not appear a red line, indicating faulty operation or reagent failur
e.
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