Fertility Assessment Kits
Product: Fertility assessment kits and their assays-.
a Indulsa kit for estimation of estrone glucuronide in urine (EG) by ELISA.
b. Corpulisa - a kit for estimation of pregnandiol glucuronide (PdG) in urine.
c. Luteolisa - a kit for estimation of leutinizing hormone (LH) in urine by ELISA.
d. Follilisa - a kit for estimation of follicle stimulating hormone (FSH) in urine by ELISA.
a. Indulsa - E 1 G assay is used in conjunction with either ovarian ultra sonography and / or cervical mucus score in:
1. Monitoring induction of ovulation therapy.
2. For timing the retrieval of preovulatory oocyte in vitro fertilization and Assisted Reproductive Technology (ART) programmes.
b. Corpulisa - PdG assays is used for:
1. Detection for occurrence of ovulation.
2. Assessment for corpus luteum function.
c. Luteolisa - LH assay is used in conjunction with FSH and / or sex steroids hormone in-
1. Investigation in delayed and precocious puberty.
2. In determining the cause of subfertility such as gonadial failure, polycystic ovarian disease and evaluation of hypothalamic pituitary gonadial axis.
d. Follilisa - FSH assay is used for estimation of FSH in urine. It is used in conjunction with LH assay for the above disorders.
Salient Technical Features:
a. Indulsa - The ovarian follicular development can be properly assessed by serial ultrasonographic scanning of ovarian follicle and serum 17 â oestradial measurements. Assessment by oestradial assay requires collection of a series of blood samples at an appropriate time during the menstrual cycle. Collection of a series of blood sample is stressful and causes discomfort to patients. It has been reported that the pattern of excretion of E 1 G, principal metabolite of oestradial in urine, closely resembles that of its parent oestradial 17 â in circulation. Therefore, estimation of E 1 G in urine is more advantageous as sampling is non invasive.
b. Corpulisa - The plasma progesterone concentration rises rapidly following ovulation and raised level of progesterone during luteal phase as an indicator of occurrence of ovulation. After achieving ovulation, a properly functional corpus luteum is used for implantation of ovum. Pregnandiol glucuronide is the principal metabolite of progesterone in urine and level of which in urine reflects those of progesterone in circulation.
c. Follilisa - FSH and LH are intimately involved in the control of the growth and reproduction activities of the gonadial tissue which synthesize and secrete male and female sex hormones. The level of FSH and LH are controlled by the sex hormones negative feedback relationship. FS promotes the proliferation of follicular cells, development of the graafian follicle and maturation of the ovary and appears to act with LH to stimulate testosterone production.
d. Luteolisa - Leutinising hormone (LH) is produced in both men and women from the anterior pituitary gland in response to gonadotropin releasing hormone (GnRH) which is released by the hypothalamus. LH is responsible for cyclical ovarian changes during the female menstrual cycle, including maturation of graafian follicle, ovulation and steroid production. LH in conjugation with FSH is required for maturation of spermatozoa in the seminiferous tubules and has the primary function of stimulating the interstitial cells to produce testosterone.
Scale of Development:
(a) The technology has been developed as follows -
(i) Bulk quantities of well-characterized and high titre antisera (about 60-70
ml for each analyte) have been raised.
(ii)Methods for preparation for enzyme analyte conjugation have been standardized.
(iii) Presentation of antisera coated plates, enzyme labeled analytes, standard analytes, QC polls, and substrate color indicator solution to suit kit format have been identified and their stability at defined conditions for defined period of time achieved.
(iv) Presentation of individual reagents in the kit format is achieved.
Therefore, products can be up-graded to any scale.
(b) Technique used for mass production of antigen/antibody and outline of the process involved.Outline of the processes involved are:
(i) Raising of polyclonal antisera to analyte by immunizing rabbits.
(ii) Purification and characterization of antisera.
(iii) Preparation of enzyme labeled analyte: Mix-anhydride reaction in case of E 1 G and PdG conjugations. One-step glutaraldehyde method for protein hormones.
(iv) Selection of appropriate dilutions of labels and antisera.
(v) Stability studies of reagents and other components of the kits.
(vi) Selection of appropriate containers and packaging materials.
(c) Annual production of the kit: Approximate 1000 kits can be produced per annum.
Status of Commercialization: The technology has been transferred to M/s. Zydus Cadila Healthcare, Ahmedabad, through Biotech Consortium India Ltd. (BCIL), New Delhi , for development, promotion, licensing and commercial exploitation of technology know-how. Presently, all serum hormone assays are being imported. A certificate mentioning satisfactory absorption of technology has been received from M/s. Zydus Cadila.
Biochemical Marker for Osteoporosis
Product: Osteocalcin is a biochemical marker for diagnosis of osteoporosis and assessment of bone pathophysiology.
Application/Uses: Weakening of bone is an age related phenomenon and more so in geriatric population. Early diagnosis by using osteocalcine can reduce the incidence of future risk of fracture.
Salient Technical Features: Osteocalcine is a low molecular weight peptide and is secreted by osteoblasts. The synthesis of osteocalcine increases with enhancement in demineralization of bone. Elevated level of osteocalcine in serum and its appearance in the circulation is an early and acceptable indicator of bone pathology. Since it is cost effective, more sensitive and stable at refrigerator temperature, it is regularly required for screening general population and renal dialysis patient and therefore, has commercial potential.
Scale of Development: Pilot experiments are completed recently, in which osteocalcine isolated was checked for purity through SDS-PAGE. Immunoreactivity of this preparation was also studied through a standard ELISA using DSL kits.
Status of Commercialization: Technology commercialization is being explored.