Hormone Neonatal

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This test is intended for the quantitative determination of estradiol level in human serum or plasma. Accurate measurement of estradiol levels is very important for both males and females. Immunoassay measurement in serum or plasma is a first-line approach in assessing estradiol levels, providing important information for diagnostic and monitoring purposes. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Recommended test for patients with any signs and symptoms of suboptimal estradiol levels. In women, these may include painful, increased occurrence of urinary tract infections (UTIs), lower abdominal pain, irregular or absent periods, mood swings, hot flashes, breast tenderness, headaches or accentuation of pre-existing migraines, depression, trouble concentrating, and fatigue among others. In men, symptoms may include fatigue, bone loss, weight gain, gynecomastia, anxiety, depression, and irritability.

 

The four main kit components are:

• A 96-well breakable solid microwells pre-coated with streptavidin
• E2 Calibrators
• E2 Enzyme Reagent comprised of E2 analog-HRP conjugate in a protein stabilizing matrix
• E2 Biotin Reagent comprised of anti-E2 biotinylated purified rabbit IgG conjugate

Features:

• Specificity: No cross-reactivity with androstenedione, cortisone, corticosterone, cortisol, dihydrotestosterone, DHEA sulfate, estriol, estrone
• Intra Assay Precision: CV ≤ 9.9%
• Inter Assay Precision: CV ≤ 4.8%
• E2 Biotin Reagent
• E2 Enzyme Reagent
• Wash Buffer (50X Concentrate)
• TMB Substrate
• Stop Solution
• Product Insert

E2 Calibrators:

• C1 (0 pg/mL)
• C2 (20 pg/mL)
• C3 (100 pg/mL)
• C4 (250 pg/mL)
• C5 (500 pg/mL)
• C6 (1500 pg/mL)
• C7 (3000 pg/mL)

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This test is intended for the quantitative determination of free triiodothyronine (fT3) level in human serum. It is intended to be used by professionals as an aid in the diagnosis of thyroid dysfunction. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Quantitative measurement of the more stable fT4/fT3 levels is believed to be more accurate in most cases. If fT3 levels are abnormal, a diagnosis can be made depending on the combination of TSH, fT4, and fT3 levels. For example, low TSH, normal fT4, and low fT3 levels usually indicates hyperthyroidism. Combining TSH with T4/T3 and fT4/fT3 measurements provides more information for the determination of thyroid status.

The two main kit components are:

• A 96-well breakable microplate pre-coated with anti-fT3 antibody
• A liquid conjugate solution composed of horseradish peroxidase with T3 (HRP-T3 conjugate)

Recommended for use:

• aid in diagnosis of thyroid disease including hyperthyroidism and thyrotoxicosis
• monitor pregnancy as well as patients undergoing treatment for thyroid disorder, pituitary disease, and thyroid cancer

Features:

• Specificity: <0.001 cross reactivity with l-thyroxine at 10 μg/mL, iodotyrosine at 10 μg/mL, diiodotyrosine at 10 μg/mL, and d-thyroxine at 10 μg/mL, respectively
• Intra Assay Precision: CV < 5.1%
• Inter Assay Precision: CV < 7.5%
• Anti-fT3 Ab Coated Microwells
• fT3 Calibrators C1-C6
• HRP-T3 Conjugate
• Wash Buffer (30X Concentrate)
• TMB Substrate
• Stop Solution
• ELISA Working Sheet
• Product Insert

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This test is intended for the quantitative determination of free thyroxine (fT4) level in human serum. It is intended to be used by professionals as an aid in the diagnosis of thyroid dysfunction. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Quantitative measurement of the more stable fT4/fT3 levels is believed to be more accurate in most cases. In a normal thyroid testing algorithm, ft4 tests are usually ordered after TSH levels are measured in the blood. If fT4 levels are abnormal, a diagnosis can be made depending on the combination of TSH and fT4 levels. For example, low TSH and high fT4 levels normally indicate hyperthyroidism, but high TSH and low fT4 levels may indicate hypothyroidism.

The two main kit components are:

• A 96-well breakable microplate pre-coated with anti-fT4 antibody
• A liquid conjugate solution composed of horseradish peroxidase with T4 (HRP-T4 conjugate)

Recommended for use:

• Aid in diagnosis of hyper- and hypothyroidism
• Distinguish between different thyroid disorders
• Aid in diagnose of pituitary disorder and female infertility
• Monitor patients undergoing treatment for thyroid disorder, pituitary disease, and thyroid cancer

Features:

• Specificity: <0.001 cross reactivity with l-triiodothyronine at 100 μg/dL, iodotyrosine at 100 μg/mL and diiodotyrosine at 100 μg/mL; 0.75 cross reactivity with d-thyroxine at 10 μg/dL, respectively
• Intra Assay Precision: CV < 1%
• Inter Assay Precision: CV < 3%
• Anti-fT4 Ab Coated Microwells
• FT4 Calibrators C1-C6
• HRP-T4 Conjugate
• Wash Buffer (30X Concentrate)
• TMB Substrate
• Stop Solution
• ELISA Working Sheet
• Product Insert

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This test is intended for the quantitative determination of follicle stimulating hormone (FSH) level in human serum. It is intended to be used by professionals only. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. FSH is a glycoprotein polypeptide hormone in the gonadotropin family that plays an important role in the regulation of normal growth, development, and reproductive function. Abnormal FSH levels have been found during aging, pregnancy, precocious puberty, menopause, castration, throughout hormone therapy, and in a variety of other medical conditions. Understanding optimal levels and accurate measurement of FSH and related hormones, therefore, is very important for both females and males. Immunoassay measurement of FSH in human serum is a first-line approach in assessing FSH levels, providing important information for diagnostic and monitoring purposes.

 

The three main kit components are:

• Solid microwells pre-coated with streptavidin
• FSH Calibrators,
• Liquid FSH Enzyme Conjugate Mixture comprised of two individual antibody conjugates: An anti-human FSH antibody labelled with horseradish peroxidase (HRP-Ab) and an anti-human FSH antibody labelled with biotin (Bio-Ab)

Features:

• Intra Assay Precision: CV ≤ 4.9%
• Inter Assay Precision: CV ≤ 8.6%
• FSH IA Control (10 mIU/mL)
• FSH Enzyme Conjugate Mixture
• Wash Buffer (40X Concentrate)
• TMB Substrate
• Stop Solution
• Product Insert
• ELISA Working Sheet
• 2 x Microplate Sealers and 1 x Resealable Plastic Bag

FSH Calibrators:

• C1 (0 mIU/mL)
• C2 (5 mIU/mL)
• C3 (10 mIU/mL)
• C4 (25 mIU/mL)
• C5 (50 mIU/mL)
• C6 (100 mIU/mL)

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This test is intended for the quantitative determination of progesterone level in human serum or plasma. Accurate measurement of levels is very important for both males and females. Immunoassay measurement in serum or plasma is a first-line approach in assessing progesterone levels, providing important information for diagnostic and monitoring purposes. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Recommended test for patients with any signs and symptoms of suboptimal progesterone levels. In women, this may include any change any changes indicative of impending menopause, and in men, symptoms may include decreased drive, prostate inflammation, urination difficulties, hair loss, weight gain, fatigue, and depression.

 

The four main kit components are:

• A 96-well breakable solid microwells pre-coated with streptavidin
• Progesterone Calibrators
• Progesterone Enzyme Reagent comprised of progesterone analog-HRP conjugate in a protein stabilizing matrix
• Progesterone Biotin Reagent comprised of anti-progesterone biotinylated purified rabbit IgG conjugate

Features:

• Specificity: No cross-reactivity with 17-OH progesterone, androstenedione, cortisone, cortisol, danazol, dihydrotestosterone, DHEA sulfate, estriol, estrone, estradiol, prednisone
• Intra Assay Precision: CV ≤ 10.7%
• Inter Assay Precision: CV ≤ 8.9%
• Progesterone Biotin Reagent
• Progesterone Enzyme Reagent
• Wash Buffer (50X Concentrate)
• TMB Substrate
• Stop Solution
• Product Insert

Progesterone Calibrators:

• C1 (0 ng/mL)
• C2 (0.3 ng/mL)
• C3 (2.0 ng/mL)
• C4 (5.0 ng/mL)
• C5 (15.0 ng/mL)
• C6 (30.0 ng/mL)
• C7 (60.0 ng/mL)

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The CTK PRL ELISA is intended to be used only by professionals only. Any interpretation or use of this test result must also integrate other clinical findings as well as on the professional judgment of health care providers. Prolactin is a polypeptide hormone in the prolactin/growth hormone receptor family. Prolactin has important biological and homeostatic functions, most notably in the female reproductive system. Its main biological action is in the induction and maintenance of lactation, but is also involved in mammary gland development, normal luteal function, and progesterone synthesis during pregnancy. If prolactin concentration in the blood is high, it is known as hyperprolactinemia and commonly caused by pregnancy, a reduction in dopamine levels, low thyroid activity, or by the presence of prolactinomas. Symptoms in women may include overproduction of milk, irregular menstrual cycles, decreased libido, infertility and decreased bone mass. Symptoms in men may include, decreased libido, infertility, gynecomastia and decreased bone mass. If prolactin concentration in the blood is low, it is known as hyperprolactinemia, which is a very rare condition that can be caused by low pituitary activity and may be associated with lowered immune response. Accurate measurement of prolactin and associated reproductive hormones are important for both males and females. Immunoassay measurement is a first-line approach in assessing prolactin serum levels, providing important information for diagnostic and monitoring purposes.  The CTK PRL ELISA is intended to be used for monitoring purposes as well as in any person with signs and symptoms of abnormal prolactin levels, including abnormalities in lactation, fertility, menstruation, and libido.

 

The three main kit components are:

• Solid microwells pre-coated with streptavidin
• PRL Calibrators
• Liquid PRL Enzyme Conjugate Mixture comprised of two individual antibodies: An anti-human PRL antibody labelled with horseradish peroxidase (HRP-Ab) and an anti-human PRL antibody labelled with biotin (Bio-Ab)

Features:

• Specificity: No cross-reactivity or interference with 1000 mIU/mL TSH, 10,000 mIU/mL FSH, 1,000 mIU/mL LH, 100,000 mIU/mL, 1 mM/mL Bilirubin, 10 µg/mL Hemoglobin, 10 µg/mL Lipids
• Intra Assay Precision: CV ≤ 5.8%
• PRL Assay Control
• PRL Enzyme Conjugate Mixture
• Wash Buffer (40X Concentrate)
• TMB Substrate
• Stop Solution
• Product Insert
• ELISA Working Sheet
• 2 x Microplate Sealers and 1 x Resealable Plastic Bag

PRL Calibrators:

• C1 (0 ng/mL)
• C2 (5 ng/mL)
• C3 (10 ng/mL)
• C4 (25 ng/mL)
• C5 (50 ng/mL)
• C6 (100 ng/mL)

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This test is intended for the quantitative determination of luteinizing hormone (LH) level in human serum. It is intended to be used by professionals only. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. LH is a glycoprotein polypeptide hormone in the gonadotropin family that plays an important role in the regulation of normal growth, development, and reproductive function. Abnormal LH levels have been found during aging, pregnancy, precocious puberty, menopause, castration, throughout hormone therapy, and in a variety of other medical conditions. Understanding optimal levels and accurate measurement of LH and related hormones, therefore, is very important for both females and males. Immunoassay measurement of LH in human serum is a first-line approach in assessing LH levels, providing important information for diagnostic and monitoring purposes.

 

The three main kit components are:

• Solid microwells pre-coated with streptavidin
• LH Calibrators
• Liquid LH Enzyme Conjugate Mixture comprised of two individual antibody conjugates: An anti-human LH antibody labelled with horseradish peroxidase (HRP-Ab) and an anti-human LH antibody labelled with biotin (Bio-Ab)

Features:

• LH IA Control
• LH Enzyme Conjugate Mixture
• Wash Buffer (40X Concentrate)
• TMB Substrate
• Stop Solution
• Product Insert
• ELISA Working Sheet
• 2 x Microplate Sealers and 1 x Resealable Plastic Bag
• Intra Assay Precision: CV ≤ 6.0%
• Inter Assay Precision: CV ≤ 9.5%

LH Calibrators:

• C1 (0 mIU/mL)
• C2 (5 mIU/mL)
• C3 (10 mIU/mL)
• C4 (25 mIU/mL)
• C5 (50 mIU/mL)
• C6 (100 mIU/mL)

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The RecombiLISA TSH ELISA Kit is a solid phase enzyme linked immunosorbent assay for the quantitative determination of the levels of Thyroid Stimulating Hormone (TSH) in human serum. The RecombiLISA TSH ELISA Kit is intended for professional use as an aid in the diagnosis of thyroid dysfunction. TSH values should not be the only factor in the determination of thyroid status, and all other available clinical and epidemiological information should be considered for an accurate diagnosis. The monoclonal anti-TSH antibody coated on the surface of the microwells specifically recognizes the junction between the α and β subunits. The HRP-conjugated monoclonal anti-TSH antibody detects the β subunit only. Combining the measurement of TSH with the thyroid hormones (T3/T4) can provide more information for the determination of thyroid status.

 

Recommended for use:

• Any person presenting with signs or symptoms of hypo or hyperthyroidism
• Any person presenting with an enlarged thyroid gland (goiter)
• Pregnant women for first trimester screening
• Any person requiring regular monitoring of treatment
• Normally, thyroid function is first assessed by detection of TSH levels in the blood.

Features:

• Sensitivity: Detects TSH levels as low as 0.035 µIU/mL
• Specificity: No cross reactivity detected with related hormones: FSH, LH
• Linearity: 1:128 dilution on 36 μIU/mL sample
• Precision: intra assay precision: CV 7.5%; inter assay precision: CV 8.0 %
• Accuracy: R2= 0.986 against Roche TSH Chemiluminescence Immunoassay
• Hook effect: No hook effect up to 8000 μIU/mL
• Interference: not affected by Hemoglobin 500mg/dL, Diltiazem 15uM, Bilirubin 20 mg/dL, Erythromycin 81.6uM, Triglycerides 3g/dL, Verapamil 4.4uM, HAMA 52.5ng/mL, T3 100ng/mL, RF 215IU/mL, T4 100ug/dL, Acetaminophen 1324uM

Anti-TSH Ab coated microwells:

• TSH standard S1
• TSH standard S2
• TSH standard S3
• TSH standard S4
• TSH standard S5
• TSH standard S6
• TSH standard S7
• HRP-anti-TSH conjugates
• TMB substrate
• Wash buffer (30X concentrate)
• Stop solution
• ELISA working sheet
• Product insert

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The RecombiLISA Total Thyroxine (T4) ELISA is a competitive solid-phase enzyme-linked immunosorbent assay for the quantitative determination of TT4 levels in human serum or plasma (sodium citrate, EDTA).

 

Features:

• Anti-T4 Ab Coated Microwells
• TT4 Calibrators: C1 (0 µg/dL)
• TT4 Calibrators: C2 (3 µg/dL)
• TT4 Calibrators: C3 (6 µg/dL)
• TT4 Calibrators: C4 (9 µg/dL)
• TT4 Calibrators: C5 (14 µg/dL)
• TT4 Calibrators: C6 (22 µg/dL)
• HRP-T4 Conjugate
• Wash Buffer (30X Concentrate)
• TMB Substrate
• Stop Solution
• Product Insert
• ELISA Working Sheet

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The RecombiLISA T3 ELISA Kit is to be used for the quantitative determination of total Triiodothyronine (T3) levels in human serum.

 

Features:

• Microwells coated with T3 analog
• T3 standards: S1 (0 ng/mL)
• S2 (0.5 ng/mL)
• S3 (1.0 ng/mL)
• S4 (2.5 ng/mL)
• S5 (5.0 ng/mL)
• S6 (10 ng/mL)
• HRP-anti-T3 antibody conjugates (20X Concentrate)
• Enzyme conjugate diluent
• Wash buffer (40X Concentrate)
• Substrate
• Stop solution
• Product insert

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This test is intended for the quantitative determination of level in human serum or plasma. Accurate measurement of levels is very important for both males and females. Immunoassay measurement in serum or plasma is a first-line approach in assessing levels, providing important information for diagnostic and monitoring purposes. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Recommended test for patients with any signs and symptoms of suboptimal levels. In females (high levels), symptoms may include excess facial hair, balding, acne, enlarged, decreased breast size, deepening of the voice, increased muscle mass, irregular menstrual cycles, low drive, mood fluctuation, obesity, and in severe cases, infertility. In men (low levels), symptoms may include loss of body hair, dysfunction, hot flashes, gynecomastia, depression, and fatigue.

 

The four main kit components are:

• A 96-well breakable solid microwells pre-coated with streptavidin
• Enzyme Reagent comprised of analog-HRP conjugate in a protein stabilizing matrix,
• Biotin Reagent comprised of anti biotinylated purified rabbit IgG conjugate

Features:

• Specificity: No cross-reactivity with androstenedione, cortisone, corticosterone, cortisol, dihydro, DHEA sulfate, estriol, estrone, estradiol, hemolysis, lipemia, rubella, spironolactone, progesterone, 17α-OH progesterone
• Intra Assay Precision: CV ≤ 9.8%
• Inter Assay Precision: CV ≤ 9.7%
• Steroid Conjugate Buffer
• Wash Buffer (50X Concentrate)
• TMB Substrate A
• TMB Substrate B
• Stop Solution
• Product Insert

Calibrators:

• C1 (0 ng/mL)
• C2 (0.1 ng/mL)
• C3 (0.5 ng/mL)
• C4 (1.0 ng/mL)
• C5 (2.5 ng/mL)
• C6 (5.0 ng/mL)
• C7 (12.0 ng/mL)

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The CTK ELISA is intended to be used only by professionals only. Any interpretation or use of this test result must also integrate other clinical findings as well as on the professional judgment of health care providers. Is a glycoprotein hormone that plays an important role in the female reproductive system. Is involved in maintenance of the corpus luteum and progesterone production, as well as various other functions, such as development of the umbilical cord, development of fetal organs, angiogenesis, suppression of uterine contractions, immunosuppression and protection from invading cells. Is detectable in the blood and urine. Abnormally low levels of during pregnancy may indicate issues such as a failing pregnancy, placental insufficiency, ectopic pregnancy, fetal death, preeclampsia, and pre-term delivery. High levels of during pregnancy may indicate multiple pregnancies, molar pregnancy, or gestational miscalculation.  Accurate quantification of levels is very important for diagnosis and monitoring of pregnancy. Immunoassays utilizing specific antibodies to detect and quantify are a first-line approach that provide accurate and reliable results. The CTK ELISA can be used for diagnosis and monitoring of pregnancy.

 

The three main kit components are:

• Solid microwells pre-coated with streptavidin,
• Liquid Enzyme Conjugate Mixture comprised of two individual antibody conjugates: An anti-human antibody labelled with horseradish peroxidase (HRP-Ab) and an anti-human antibody labelled with biotin

Features:

• Specificity: No cross-reactivity or interference with 1000 mIU/mL TSH, 10,000 mIU/mL FSH, 1,000 mIU/mL LH, 5,000 ng/mL PRL, 1 mM/mL Bilirubin, 10 µg/mL Hemoglobin, 10 µg/mL Lipids
• Accuracy: correlation coefficient 0.979 at normal range or 0.960 during early pregnancy with a reference method
• Intra Assay Precision: CV ≤ 6.5%
• Assay Control
• Enzyme Conjugate Mixture
• Wash Buffer (40X Concentrate)
• TMB Substrate
• Stop Solution
• Product Insert
• ELISA Working Sheet
• 2 x Microplate Sealers and 1 x Resealable Plastic Bag

Calibrators:

• C1 (0 mIU/mL)
• C2 (5 mIU/mL)
• C3 (10 mIU/mL)
• C4 (25 mIU/mL)
• C5 (50 mIU/mL)
• C6 (100 mIU/mL)