Congenital hypothyroidism affects 1 in 3000 babies worldwide. It is the most common cause of treatable mental retardation. A baby with congenital hypothyroidism loses up to ½ I.Q. point a day during the first month of life. This lose in I.Q. is permanent. Diagnosing and starting treatment for congenital hypothyroidism as soon as possible minimizes permanent brain damage.

Congenital hypothyroidism is an endocrine emergency. It is a disease that is very easy to diagnose. The treatment, thyroxine—a medication taken by mouth daily-- is widely available, inexpensive, safe, and effective. Because brain damage due to congenital hypothyroidism starts before clinical signs of brain damage are apparent, every baby must be screened for congenital hypothyroidism. The best time to screen a baby for congenital hypothyroidism is after the baby is 48 hours old. Screening uses a few drops of blood from a heel puncture and seamlessly fits in with blood sample collection for additional newborn screening tests.

Screening programs for congenital hypothyroidism were introduced in the 1970’s. The newborn thyroid screening procedures in use today use dried blood spots sent to state public health laboratories. These are the same procedures that were developed over 40 years ago and have not been updated. They are obsolete, inaccurate, and time-consuming. Current newborn screening programs are able to screen only 30% of the world’s newborns. In 50% of newborns screened, the diagnosis is delay and the treatment inadequate. In 10% of hypothyroid newborns, the diagnosis is missed.

i-calQ has developed the next generation point-of- care newborn thyroid screening test. I-calQ’s technology measures TSH, the same hormone that the current day newborn screening programs measure, but uses a disposable, more accurate test, similar to a home pregnancy test, which is read by a smartphone. Instead of taking days to weeks report test results, i-calQ can test babies anywhere and anytime and provide results in minutes. The diagnosis can be confirmed and treatment started immediately. With i-calQ’s technology, brain damage from a lack of thyroid hormone can be avoided and babies can achieve their maximum intellectual potential.

i-calQ’s newborn screening technology consists of a disposable TSH test, a smartphone attachment for using a smartphone camera to read the test, and a smartphone app to interpret the test results and send the results to an electronic medical record. i-calQ’s technology is faster, better, and less expensive than traditional dried blood spot newborn thyroid screening. The technology has been used on tens of thousands of babies and is approved for use by the U.S. F.D.A., the European Union, and the Thailand F.D.A. The i-calQ- newborn-screening website (www.i-calQ- newborn-screening.com) provides detailed instructions on how to download the app, perform a test, and answers many frequently asked questions. The website has a link to contact i-calQ directly for additional information.

Welcome to next generation newborn screening and smarter babies.

1. Can I use any model smartphone to read an i-calQ newborn thyroid test?
The i-calQ smartphone attachment is designed for use with a Samsung Galaxy Core Prime smartphone and will not work with other smartphones.

2. What version of Android is required?
The i-calQ app is designed to run on Android 5.0 or higher.

3. How many times can I use the i-calQ app?
The initial download allows you to use the app 300 times on a single handset. The app alerts you when 50 uses are remaining. Contact your authorized i-calQ distributor to obtain additional app uses.

4. How many times can I use the i-calQ reader?
The reader is reusable. When not in use, store the reader in a clean place out of direct heat and light.

5. Can the reader be cleaned?
Yes. Clean the reader with a dry clean cloth.

6. Why is the app calibrated before each use?
The app is extremely accurate. This accuracy is achieved by monitoring the lighting conditions when a test is read. Calibration enables the app to precisely adjust to any changes in lighting or illumination.

7. Why does the test use serum and not blood?
The test measures the concentration of TSH (thyroid stimulating hormone). TSH circulates in the serum component of blood. The amount of serum present in blood can vary from 30% to 70% in babies. This variability affects the accuracy of the results. Measuring TSH in blood, especially in dried blood spots, is not accurate.

8. Can plasma be used for testing?
Plasma is not recommended to use for testing. Plasma contains anticoagulants that can interfere with the test.