Microsoft word - 33-2567 _fsh s_ b.doc

INSTANT-VIEW® FSH Dip-Strip Test
SIMPLE ASSAY
MATERIALS REQUIRED BUT NOT PROVIDED
RAPID VISUAL RESULTS
FOR QUALITATIVE IN VITRO DIAGNOSTIC USE
INTENDED USE
STORAGE AND STABILITY
The FSH Dip-Strip Test is a qualitative immunoassay designed to detect Store the product at room temperature 15-30°C (59-86°F). Each follicle stimulating hormone (FSH) in human urine at concentrations equal to or greater than 40 mIU/mL. This product is for health care professional device may be used until the expiration date printed on the label if Do not freeze and/or expose this kit to temperatures over 30°C. SUMMARY AND EXPLANATION OF THE TEST 1,2,3,4
FSH is secreted by the β-cells of the anterior pituitary under the control of SPECIMEN COLLECTION
the gonadotropin releasing hormone produced in the hypothalamus. it Each urine specimen must be collected in a clean container. consists of two subunits designated alpha (α) and beta (β). The α sub-units Specimens may be kept at room temperature for 8 hours, at of FSH are biochemically identical with that of LH, TSH and FSH, whereas 2-8°C for up to 3 days and at -20°C or lower for prolonged the β sub-unit of FSH is biochemically unique and confers biological and immunological specificity. The β sub-unit determines the bioactivity of FSH. PRECAUTIONS
FSH and LH exist in both males and females for normal sexual function. The instructions must be followed to obtain accurate The secretory patterns are very different for males and females. In sexually mature adults, FSH and LH are secreted not in constant Do not open the sealed pouch unless ready to operate the amounts, but in pulses that result in rapid fluctuations over the entire reference range. Concentration of FSH and LH may increase or decrease by 50 to 100%. Therefore samples obtained within the same day from the same individual may vary, but be within the reference range. Dispose of all specimens and used assay materials in a In mature females FSH initiates the growth and development of ovarian follicles. During ovulation, when is ruptured, the follicle (corpus luteum) PROCEDURE
secretes estradiol and progesterone, which control the circulating levels of FSH by a negative feedback effect on the hypothalamus. In materials, including tests, must be equilibrated to room
menopause, there is a decrease in estradiol secretion due to the diminished ovarian function. As a result of the lack of a negative temperature before testing.
feedback effect, with diminished estradiol, the circulation FSH levels Open the foil pouch at the notch and remove Dip the test in the specimen for at least 10 In the mature male, FSH is associated with the stimulation and maintenance seconds and start the timer. Keep the specimen surface at the level of spermatogenesis. Testosterone and estradiol have the role of providing the negative feedback signal to the hypothalamus for controlling the release of Remove the test from the specimen, and place FSH. Infertility in males may be due to hypogonadism as a result of primary testicular failure. Testicular failure may be functional failure to mature or a Strong positive results may be observed in 2-3 result of germ cell damage. In those conditions, FSH levels are raising minutes. Weak positive results may take up to 5 minutes to dramatically due to the lack of a negative feedback effect. Low FSH values may relate to insufficient Gonadotropin production and IMPORTANT: Do not interpret the results after 10 minutes.
pituitary or hypothalamic dysfunctions. Pituitary dysfunction is often a causative agent of secondary gonad failure, which results in decreased INTERPRETATION OF RESULTS
secretion of both FSH and LH. The net effect in both males and females is infertility. This is also occurred with central nervous system disorders and following administration of certain depressant drugs such as the Although there are significant exceptions, ovarian failure is indicated when FSH concentrations exceed 40 mIU/mL. PRINCIPLE OF THE PROCEDURE
This assay is a one-step lateral flow chromatographic immunoassay. The test strip includes (1) a conjugate pad containing mouse monoclonal anti-FSH antibody conjugated to colloidal gold, and (2) nitrocel ulose membrane containing a test line (T line) and a control line (C line). When the proper amount of specimen is applied to the sample pad of the device, FSH in the specimen binds to the anti-FSH antibody-gold conjugate in the conjugate pad to form a complex and migrates along the membrane strip. If the specimen contains FSH at a level equal to or greater than 40 mIU/mL, the complex will bind to the capture antibody coated on the T line to develop a colored band. If the specimen does not contain FSH or the FSH level is below the detectable level, the T line will not develop. PRELIMINARY
POSITIVE
NEGATIVE
The C line is coated with goat anti-mouse antibody, which will bind to the gold-antibody conjugate and form a colored line regardless of the Positive:
If both the C line and T line appear, the FSH concentration of the specimen is equal to or higher than 40 mIU/mL. REAGENTS AND MATERIALS SUPPLIED

Negative:
50 Dip strips, each sealed in a foil pouch with a desiccant If only the C line appears, the FSH concentration of the specimen is not INSTANT-VIEW® FSH Dip-Strip Test
QUALITY CONTROL
Invalid:
Built-in Control Features
If no C line develops within 5 minutes, the result is invalid. In this case, This test contains built-in control feature, the C line. The do not report test results. Repeat the assay with a new test. If the presence of the C line indicates that an adequate sample result is still invalid, stop using the test and contact the manufacturer. volume was used and that the reagents migrated properly. If a C line does not form, the result is invalid. Review the procedure and repeat with a new test. External Quality Control
Good Laboratory Practice recommends using external controls,
positive and negative, to ensure the proper performance of the
assay.

LIMITATIONS
•
This kit is not intended for any use other than an aid in the diagnosis and treatment of pituitary and gonadal disorders. In certain cases of infertility, treatment with human gonadotropin poses a potential problem for the accurate measurement of FSH. The FSH administered can cause the individual to produce antibodies to FSH, which will interfere with the assay results. Positive results must be evaluated with other data by a physician before diagnosis. EXPECTED VALUES
This test is designed to detect FSH at the level as low as 40 mIU/mL
(WHO 2nd IRP 78/549) in urine.
PERFORMANCE CHARACTERISTICS
1.
Sensitivity
This test is capable of detecting FSH at the level as low as
40 mIU/mL in urine, standardized to the WHO 2nd IRP 78/549.
Specificity
The α subunit of hTSH, hLH, and hCG is similar to that of FSH,
which may cause cross reactivity between those hormones (4).
High
1,000 µIU/mL), hLH (up to 300 mIU/mL), and hCG (up to 300 mIU/mL) spiked in FSH positive (spiked to 40 mIU/mL) and negative specimens were tested, separately, in the FSH Dip-Strip Test, and did not affect the expected results in that study. Interfering Substances
The following analytes spiked in urine pools containing 0, or
40 mIU/mL FSH (WHO 2nd IRP 78/549) were tested,
separately, in the FSH Dip-Strip Test, and did not affect the
expected results in that study.
Chemical Analytes
Compound
Concentration
INSTANT-VIEW® FSH Dip-Strip Test
Biological Analytes
Compound
Concentration
Positive and negative urine pools were tested at various pH levels. pH ranges from pH 5 to pH 9 did not affect the expected results in the study. Bacteria
Bacteria
Concentration

REFERENCES
1.
Pierce JG, Parsons TF. Glycoprotein hormones: structure and function. Annu Rev Biochem. 1981;50:465-95. Daughaday WH. Adenohypophysis. In: Williams RH, editor. Williams Textbook of Endocrinology. 2nd ed. Philadelphia: W.B. Saunders Co.; 1981. Shome B, Parlow AF. Human follicle stimulating hormone (hFSH): first proposal for the amino acid sequence of the alpha-subunit (hFSHa) and first demonstration of its identity with the alpha-subunit of human luteinizing hormone (hLHa). J Clin Endocrinol Metab. 1974 Jul;39(1):199-202. Reame N, Sauder SE, Kelch RP, Marshall JC. Pulsatile gonadotropin secretion during the human menstrual cycle: evidence for altered frequency of gonadotropin-releasing hormone secretion. J Clin Endocrinol Metab. 1984 Aug;59(2):328-37. Distributed by Labstix Diagnostics Pty Ltd P O Box 904520 0043 Tel : (013) 947 8049 Fax : 086 669 7760 [email protected] www.labstix.co.za

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