New born screening

Newborn screening is a remarkable public health success story. By screening
babies at birth, clinicians are alerted to potentially life-threatening and debilitating conditions. Since the 1960's, countless babies throughout the world have benefited from newborn screening.
A successful screening program is not just about laboratory testing; it is about improving lives
Our product line includes:

  • Screening Assays

  • DNA Confirmation Reagents

  • HPLC Instrumentation

  • EIA Instrumentation

  • Dried Blood Spot Punching

  • Data Management Software


Galactosemia is an inherited disorder of galactose metabolism. It is typically caused by a deficiency in one of three enzymes, the most important being galactose-1-phosphate uridyl transferase. Long-term consequences of galactosemia include mental retardation, developmental abnormalities and even death.
                        C:\Documents and Settings\Administrator\Desktop\nb.bmp
Microplate Neonatal GALT Assay Kit

Types of Assays:

Bio-Rad offers two assays for galactosemia screening, which are as follows:

  • Bio-Rad Microplate Neonatal Total Galactose Assay.

This is an enzymatic colorimetric end-point method for the determination of total D (+)galactose [D(+)galactose + galactose-1-phosphate] in dried blood spot specimens. It is reconginized as worldwide market is easy automated and can be performed with any microplate reader.

  • Bio-Rad Microplate Neonatal GALT Assay:

It measures galactose-1-phosphate uridyl transferase activity in neonatal dried blood spot samples as a screen for galactosemia. It is free of background interferences associated with fluorometric assay methods. It is the replacement for the subjective Beutler assay.


PKU is an inherited metabolic disorder that can lead to mental retardation when untreated. Most PKU cases are the result of a deficiency in the enzyme phenylalanine hydroxylase. Early detection and treatment of PKU is necessary for the prevention of mental retardation.
The Bio-Rad Microplate Neonatal PKU Screen quantitatively determines phenylalanine levels in neonatal dried blood spot samples as a screen for phenylketonuria.

Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency:

Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency is one of the most common hereditary enzyme disorders. The G6PD enzyme is found in most body cells. G6PD deficiency impairs the stability of red cell membranes and makes red cells susceptible to destruction by strong oxidizing agents. Affected persons can develop hemolytic anemia when exposed to certain drugs and foods, such as fava beans.

The Bio-Rad Microplate Neonatal G6PD Assay is a rapid, colorimetric assay for the qualitative determination of glucose-6-phosphate dehydrogenase deficiency in dried blood spot specimens. It is not affected by temperature and free of red blood cell lysis steps.

Cogential Adrenal Hyperplasia:

CAH is an inborn error of metabolism that results from an inherited recessive defect in any of the five enzymatic steps required to synthesize cortisol from cholesterol. The complete or partial deficiency of 21-hydroxylase can leads to elevated levels of 17a-OH progesterone (17-OHP) in 90% to 95% of all CAH cases.
C:\Documents and Settings\Administrator\Desktop\dd.bmp


CAH exists in several forms: Classical [Salt Wasting (SW), Simple Virilizing (SV)], and Non-Classical (NC). If left untreated, the SW form can result in life-threatening adrenal crises within the first weeks of life and precocious growth in both sexes. Non-classical CAH may result in persistent slight elevations of 17-OHP from birth with clinical mani-festations occurring later in life.The Bio-Rad Microplate Neonatal 17-OHP Assay is a quantitative assay for the determination of 17a-hydroxyprogesterone in neonatal dried blood spot specimens.


Cogential Hypothyroidism:

Congenital Hypothyroidism (CH) is a condition caused by improper thyroid function. Normally, TSH levels surge after birth, triggering a rise in thyroid hormone. In primary CH, the thyroid gland does not respond to TSH stimulation, resulting in diminished thyroid hormone levels and elevated TSH levels. CH can result in growth failure, deafness, neurological abnormalities and mental retardation. Early treatment is critical to prevent permanent mental retardation and cretinism.
C:\Documents and Settings\Administrator\Desktop\22.bmp
The Bio-Rad Microplate Neonatal TSH Assay is a quantitative assay for the determination of Thyroid Stimulating Hormone (TSH) in dried blood spot specimens.

VARIANT™ a-Thalassemia Short Program:

This program provides accurate determination of percent hemoglobin Bart's in whole blood, using the precision of HPLC. The assay improves on traditional methods, such as electrophoresis and open column tests, which are time-consuming and can yield subjective results.

Objective and precise results: Full automation reduces technique-dependent errors and streamlines workloads. The percent Hb Bart's result is calibrated for accuracy and precision.

Additional laboratory utility: This assay adds to your laboratory's capabilities without the need for an additional capital expenditure. It extends the utility of the existing VARIANT™ system for more cost-effective operation

The VARIANT™ Sickle Cell Short Program:

 This program provides detection and presumptive identification of hemoglobins S, F, A, C, D and E in newborn dried blood spot specimens. Rapid analysis and unattended operation maximize productivity and efficiency.
                      C:\Documents and Settings\Administrator\Desktop\pp.bmp

VARIANT Sickle Cell Short Program 

  • Increased productivity: The 3-minute specimen analysis delivers high throughput for your laboratory. Operation is performed unattended.
  • Objectivity: Hemoglobins S, F, A, C, D and E are detected based on quantitative thresholds. Patient data can be easily stored off-line on the laboratory's information management system.
  • Relative ratios: Relative ratios between different hemoglobins can help distinguish sickle cell disease (FS) from sickle cell trait (FAS) and sickle/b-thalassemia (FSA).

VARIANTnbs Newborn Hemoglobin Screening System and Sickle Cell Program:

VARIANT™nbs, the next generation system for newborn hemoglobin screening, brings the power of automation to the hemoglobin screening laboratory. As many as 864 samples can be loaded and analyzed in a single run, allowing for maximum unattended system operation.

VARIANTnbs Program Benefits:

  • Identifies the most common hemoglobin variants
  • High capacity screening
  • Electronic chromatogram storage and retrieval
  • Objective sample analysis
  • Fully automated operation
  • Smart reports and flexible worklist import

              C:\Documents and Settings\Administrator\Desktop\re.bmp

Example patient report showing the presence of an abnormal hemoglobin peak in the Hemoglobins-S window


For more detail:


Bio-Plex® 2200 System
Bio-Rad Diabetes Testing
BioLogic DuoFlow System
CFX 96
Gamma Counters
New born screening
Real Time PCR Detection System
Vertical Electrophoresis