Raj Biosis Private Limited - Immunoassay Reagents

Screening infections in the gastrointestinal tract

H. pylori SA is an antigen produced by the immune system to cope with the H.Pylori infection. The level of the antigen examined through the stool serves as a more reliable indicator of the infection than by the one via a blood test, which does not tell if the infection is still active.

Enable monitoring and managing of androgen level

Testosterone plays a key role in the development of male reproductive organs and secondary sexual traits. This test would provide clues on the health of related tissues and organs, which may be related to infertility, tumors in testicles, and even irregular periods in females.

• The Finecare2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with FinecareFIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV.The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision.
• STORAGE AND STABILITY
  1. Store at 4-30C in the sealed pouch up to the expiration date printed on the package. Do not freeze.2. The test device should be used within 1 hour after taking out from the foil envelope.3. Keep away from sunlight, moisture and heat.4. Kit contents are stable until the expiration date printed on the outer box.

• INTENDED USE
  The Finecare One Step cTnT Rapid Quantitative Test along with FinecareFIA Meters is a fluorescence immunoassay for quantitative determination of cTnT concentration in human venous whole blood, serum or plasma specimen. It is mainly used as an aid to the diagnosis of myocardial infarction.
• STORAGE AND STABILITY
  1.Store at 430 C up to the expiration date printed on the package.2. Do not remove the Test Cartridges from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

• INTENDED USE
  The FinecareLp-PLA2 Rapid Quantitative Test is a fluorescence immunoassay used along with FinecareFIA System for quantitative determination of Lp-PLA2 in human serum, plasma or whole blood. The test is used as an aid to the assessment of the coronary heart disease (CHD) and ischemic stroke.
• STORAGE AND STABILITY
  1. Store the test kit at 4-30 up to the expiration date printed on package.2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing.3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

• INTENDED USE
  The FinecareAMH Rapid Quantitative Test is a fluorescence immunoassay used along with FinecareFIA Meters for quantitative measurement of AMH in human whole blood, serum or plasma. The test is mainly used in the assessment of the ovarian reserve and as an aid in the diagnosis of polycystic ovary syndrome (PCOS).
• STORAGE AND STABILITY
  1. Store the test kit at 430C up to the expiration date printed on the package.2. If removed from refrigerator, allow the test to return to room temperature for 30 minutes before testing.3.Do not remove the cassette from the pouch until ready to use. The test cassette should be used within 1 hour once opened.

• INTENDED USE
  The FinecarefT3 Rapid Quantitative Test is a fluorescence immunoassay used along with FinecareFIA Meters for quantitative determination of free triiodothyronine (fT3) in human whole blood serum or plasma. The test is used as an aid to the assessment of thyroid function
• STORAGE AND STABILITY
  1. Store the test kit at 430 up to the expiration date printed on package.2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing.3.Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

• INTENDED USE
  The FinecareS100 Rapid Quantitative Test is a fluorescence immunoassay used along with FinecareFIA Meters for quantitative determination of S100 in human serum, plasma or whole blood. The test is used as an aid to the assessment of the level of cerebral injury.
• STORAGE AND STABILITY
  1. Store the test kit at 4 30 up to the expiration date printed on package.2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

• INTENDED USE
  The FinecareFerritin Rapid Quantitative Test is a fluorescence immunoassay used along with FinecareFIA Meters for quantitative determination of Ferritin in human whole blood, serum or plasma. The test is used as an aid to the assessment of iron deficiency anemia.
• STORAGE AND STABILITY
  1. Store the test kit at 4 30 up to the expiration date printed on the package.2. Do not remove the Test Cartridge from the pouch until ready to use. The Test Cartridge should be used within 1 hour once opened.

Thyroid Stimulating Hormone (TSH) Plus
Supporting to diagnose abnormal thyroid functions with high sensitivity

One needs an adequate level of thyroid hormone. The excessive or insufficient level would cause various abnormalities in human physiology. The TSH test can deliver the required answer about the hormone level in 12 minutes with fingertip blood.

Troponin I (Tn-I) Plus can diagnose myocardial infarction and myocardial necrosis at an early stage with high sensitivity by accessing Tn-I level in the blood, thus can help prevent progression to more severe cases.

Troponin I (Tn-I) can diagnose myocardial infarction and myocardial necrosis at an early stage by accessing Tn-I level in the blood, thus can help prevent progression to more severe cases.

The appearance of elevated CK-MB levels in serum is highly specific and sensitive for myocardial cell wall injury. Since it varies from one to another, other biomarkers such as Troponin I should be considered together with the CK-MB test to assess heart health. It provides solution to measure blood CK-MB level on a POC level.

The level of CK-MB, together with Troponin I and other cardiac-related biomarker levels, plays a vital role in assessing the AMI. It can provide close to the real-time value of CK-MB in the ER and equivalent facilities to help clinicians to produce up a treatment plan.

hsCRP is a test for testing the low level of CRP. Significantly high CRP levels are most likely a sign of a serious underlying medical condition. The most common cause is a severe infection, but there are other specific causes leading to a high CRP level. This test measures the level of CRP in 3 minutes.

hsCRP measures the level of CRP down to a lower level, which reveals the risk for heart disease and stroke in people who shows no apparent signs of the heart disease. This test returns results in just 3 minutes with fingertip blood. The high sensitivity and the rapid turnaround make the test suitable for initial assessment of the cardiac risk.

ST2 signals the presence and severity of adverse cardiac remodeling and tissue fibrosis, which occurs in response to myocardial infarction, acute coronary syndrome, or worsening heart failure. This test provides prognostic information, which is independent of other biomarkers used to probe the cardiac event.

The presence of D-dimer in blood indicates that thrombin has been formed and fibrin generated from fibrinogen in vivo as a result of activation of the coagulation system. This test measures the level in the blood to help assess the thrombotic state.

Assessing to distinguish and diagnose rheumatoid arthritis

This test helps to diagnose rheumatoid arthritis, distinguish it from other types of arthritis and other inflammatory diseases, and ensure proper treatment by rapidly and accurately quantifying RF IgM in blood.

This is a screening test that quantifies microalbumin from the first urine in the morning or random concentrated urine to check the extent of kidney damage and predict the progression to kidney failure. Continuous measurement of microalbumin concentration can help patients receive appropriate treatment and confirm treatment effects.

Assessing and monitoring function of pituitary gland

This test helps evaluate pituitary function by quantifying luteinizing hormone in the blood, to diagnose pituitary gland disease, and to determine congenitally or acquired gonadotropin dysfunction.

Distinguish pregnancy and abnormal pregnancy

The -hCG test can be used to confirm pregnancy, the age of the fetus, abnormal pregnancy (ectopic pregnancy), potential miscarriage, and down syndrome.

Assessing to diagnosis & to monitor thyroid diseases(T3)

This test assesses the level of T3 in the blood to diagnose thyroid dysfunction, help to receive appropriate treatment, and help to confirm the treatment effect through periodic measurement.

Assessing to diagnose rheumatic fever and glomerulonephritis

ASO is an antigen against the toxin produced by the streptococci. The presence of these antibodies indicates an exposure to these bacteria. The ASO test can detect GAS (group A streptococcus) infection with a blood sample.

With Dengue NS1 Ag, one can diagnose Dengue virus infection early and provide means of prognosis monitoring

Dengue fever is an acute febrile disease caused by the dengue virus, mainly transmitted by mosquitoes. Reinfection is not uncommon and can grow into severe dengue fever. Dengue NS1 Ag can help with the diagnosis of dengue infection at an early stage, which should help with treatment planning and prognosis monitoring.

Assessing to diagnose acute allergic diseases

This test assesses IgE in blood to support diagnosing of acute allergic diseases.

Monitoring deficiency/excess of iron & inflammation

Ferritin is a universal intracellular protein that stores iron and releases it in a controlled fashion. Too little ferritin can lead to anemia, while too much to liver disease, rheumatoid arthritis, other inflammatory conditions, or hyperthyroidism. The ferritin test measures the level of ferritin in the blood.

Measuring the activity of the carcinoma in the body

A high level of CEA in adults can be a sign of certain types of cancers in organs like the colon and rectum, prostate, ovary, lung, thyroid, or liver. The CEA test measures the level of CEA in the patient blood including treatment response and recurrence of cancer patients.

Evaluating ovarian function & predicting controlled ovarian hyperstimulation

AMH levels help predict the remaining egg reserve. This can tell a lot about the reproductive issues, including the onset of menopause, amenorrhea, polycystic ovary syndrome. This test also tells the expected response to controlled ovarian hyperstimulation to achieve pregnancy in IVF.

Assessing to diagnosis & to monitor thyroid diseases(T4)

Thyroxine (T4) is a type of thyroid hormone. An abnormal amount of T4 may indicate thyroid disease. The T4 test measures total T4, including T4 bonded to protein and free T4. A T4 test will help determine what type of problem is affecting the thyroid.

Monitoring ovulation abnormalities and predicting miscarriage & ectopic pregnancy

The progesterone test kit measures the level of progesterone in the blood. The progesterone test alone is not enough to diagnose a particular problem. But the result may help provide answers to causes of infertility, risk of miscarriage, ovulation, and ectopic pregnancy.

Assessing to diagnose hypothalamic impairments & pituitary disorders

This test helps select and diagnose mammary gland development, infertility treatment and pituitary diseases by quantifying blood PRL.

Diagnosis of early menopause & ovarian degeneration and infertility

This test can help figure out the cause of infertility, problems with ovarian functions, menstrual abnormalities and congenital or acquired gonadotropin development disorder or infertility.