Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
CATALOG
INTENDED USE
SUMMARY
SPECIMEN COLLECTION
TEST PROCEDURE
( STRIP / CASSETTE / MIDSTREAM )
INTERPRETATION OF RESULT
( STRIP / CASSETTE / MIDSTREAM )
QUALITY CONTROL
PERFORMANCE CHARACTERISTICS
STORAGE AND STABILITY
CATALOG
Catalog No. Product Name
ABT-FT-A4 FSH Urine Strip
ABT-FT-B4 FSH Urine Cassette
ABT-FT-C4 FSH Urine Midstream
Accu-Tell ® Rapid FSH Test Cassette is an immunochromatographic in vitro assay for qualitative determination of human follicle-stimulating hormone (FSH) in urine.
Follicle-stimulating hormone is a glycoprotein produced by the anterior pituitary gland. It plays a central role in reproductive processes. A FSH molecule contains two non-covalently linked subunits: a common subunit designated α and a hormone specific subunit designated β.
Accu-Tell ® Rapid FSH Test Cassette detects FSH concentrations of 25 mIU/ml and higher. A test device is a test membrane with anti-FSH antibodies and conjugates in a stabilizing matrix containing proteins and sodium azide.
The urine specimen must be collected in a clean and dry container without any preservatives. Urine samples exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain clear supernatant for testing. Urine specimens may be stored at 2-8 ℃ for up to 48 hours prior to assay. Urine containing excessive bacterial contamination should not be used as this may cause spurious results.
TEST PROCEDURE
Read the entire procedure carefully prior to performing any tests. Allow test strips and urine samples to equilibrate to room temperature (18-30℃) prior to testing.
1. Remove the test strip from the pouch.
2. Immerse the strip with arrow downwards into the specimen. Do not immerse the maximum line. Take the strip out after 3 seconds and lay the strip flat on a clean, dry, non-absorbent surface.
3. Wait for colored bands to appear. Depending on the concentration of FSH in the test specimen, strong positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (5 minutes) is required. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS
NEGATIVE Only one colored band appears on the control region or the test band is lighter than the control band. The FSH concentration of the specimen is below the detection sensitivity of 25mIU/ml.
POSITIVE If two colored bands are visible and the test band is equal to or darker than the control band. The FSH is present in the specimen at or above the detection sensitivity of 25 mIU/ml.
INVALID No visible band at all. Repeat test with a new test strip.
TEST PROCEDURE
Read the entire procedure carefully prior to performing any tests. Allow test cassette and urine samples to equilibrate to room temperature (18-30℃) prior to testing.
1. Remove the test cassette from the pouch.
2. Draw about 5 drops urine sample into the pipette, and dispense it into the sample well on the cassette.
3. Wait for colored bands to appear. Depending on the concentration of FSH in the test specimen, strong positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (5 minutes) is required. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS
NEGATIVE Only one colored band appears on the control region(C) or the test band is lighter than the control band. The FSH concentration of the specimen is below the detection sensitivity of 25mIU/ml.
POSITIVE If two colored bands are visible and the test band is equal to or darker than the control band. The FSH is present in the specimen at or above the detection sensitivity of 25 mIU/ml.
INVALID No visible band at all. Repeat test with a new test strip.
TEST PROCEDURE
Read the entire procedure carefully prior to performing any tests. When you are ready to test, remove the test and take off the cap. With the test pointing downwards, hold the absorbent sampler in your urine stream for 4 –5 seconds. Do not stream pass the arrow end and taking care not to splash the window. Hold the test for a few seconds or lay the test flat. When you see the urine pass the show window and purple line appear, the test is complete and has worked correctly. Depending on the concentration of FSH in the test specimen, strong positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (5 minutes) is required. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS
NEGATIVE Only one colored band appears on the control region(C) or the test band is lighter than the control band. The FSH concentration of the specimen is below the detection sensitivity of 25mIU/ml.
POSITIVE If two colored bands are visible and the test band is equal to or darker than the control band. The FSH is present in the specimen at or above the detection sensitivity of 25 mIU/ml.
INVALID No visible band at all. Repeat test with a new test midstream.
A procedural control is included in the test. Correct procedural technique and test midstream performance is confirmed when a red line appears at the control region of the membrane.
PERFORMANCE CHARACTERISTICS
Sensitivity: Rapid FSH Test Midstream detects FSH concentration of 25 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard.
Specificity: The addition of LH (300 mIU/ml), and TSH ( 1000 mIU/ml) to negative (0 mIU/ml FSH) and positive (25 mIU/ml FSH) specimens showed no cross-reactivity.
Store as packaged in the sealed pouch at room temperature ( 18-30 ℃). The kit is stable within the expiration date. The kit should be kept away from direct sunlight, moisture and heat. Do not freeze.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
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