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Labtech
The latest in Thyroid Diagnosis
Tests for diagnosis of thyroid disorders are carried out
in India for the last 25 years.
Dr A Velumani |
Tests for diagnosis of thyroid disorders are carried out in
India for the last 25 years. It all started with the development of the Nobel
prize winning technology, Radioimmunoassay (RIA) and its introduction in India
by BARC. Dr A M Samuel, former Director Biomedical Group and Head Radiation
Medicine Centre, BARC, late Dr R D Ganatra, former Head RMC, Dr KB Desai, RMC
and Dr R S, former Head Isotope Division, BARC, spent more than a decade in
perfecting the technology so that it reaches the common man through research
institutes in the country and by developing ready to use kits.
But the pace at which they were taking it ahead made private laboratories impatient
and more than two dozen private laboratories in the country were well equipped
in 1990 to deliver it to the common man. New technology, low volume, more demand
and less supply made thyroid testing expensive till 1995. They were as costly
as Rs 800 to Rs 1,200 and laboratories for convenience shifted to a still costlier
technology Chemiluminescence (CLIA) and that added more to the costs of thyroid
testing.
Only in the late 90's, the supply became surplus than the demand, true competition
of technologies came in, true capabilities of service providers came in and
that made good news for the end user. In fact, the cost of testing has been
consistently coming down for the last five years and what was costing as high
as Rs 10,00 for a patient is now only Rs 250.
 Incidentally
and even interestingly, thyroid testing, capability and volume, has become an
indicator of a laboratory status and its dignity which made all laboratories
to chase for its volumes. Competition in technologies have driven ELISA (enzyme
based assays) out of thyroid testing, while RIA is gasping for its survival.
Decisive moves by the CLIA manufacturers are knocking out the competition with
a tomorrow in mind. Of the CLIA technology too, there are only two (Bayer and
Abbott) who are aggressive and have vision and volumes too. So the change has
brought some orderliness though it has brought in some type of monopoly (volume
driven) for laboratories (in 1996 there were 3,000 laboratories but now it is
only 300 laboratories), distributors (more than 50 were there and now there
are hardly 10) and even manufacturers from more than 100 globally have finally
come down to only a dozen. This means, consolidation of the industry.
Tests employed in Thyroid diagnosis
There are totally seven tests used in Thyroid diagnosis and the most widely
used in routine diagnosis are Thyroxine (T4), Triiodothyronine (T3) and Thyroid
Stimulating Hormone (TSH). Other tests employed in diagnosis of thyroid diagnosis
in pregnancy are free thyroxine and free Triiodo Thyronine. Thyroid autoimmune
disorders are well known and they are diagnosed using two antibodies which are
known as Anti Thyrogulobulin Antibodies and Anit Microsomal Antibodies and the
test which is used in monitoring patients with differentiated thyroid carcinoma
(cancer) is Thyroglobulin or Tg. The tests other than T3T4TSH are relatively
costly which is a main reason why the requests for other tests are not adequate
in a laboratory.
It is almost like what happened in the telecom industry.
If a man spent Rs 80 for a three minute call from Mumbai to Delhi in 1996,
in 2006 he spends Rs 3 to 10 only. What brought this unexpected change?
Is it a single company or a single technology or single philosophy? It is
a change due to nature and the following have contributed for the changes.
- Emerging air cargo and courier industry which made possible for specimen
to move from one part of the country to other within a couple of hours.
- Evolving web server technologies which made access to results from
all parts of the country (even world) without losing any time.
- Increasing competition among technologies which turned CLIA from
a costlier technology (compared to RIA) to a cheaper alternative.
- Inherent pressures among the distributors to invest on the hardware
required for the technology in the laboratory on behalf of the laboratory.
- Interesting race among the laboratories to gather volumes at the
cost of profits to establish comforts of volumes of economy in the long
run.
- Volume-driven advantages in cost of reagents and their role in quality
enhancements.
- Affordable automations for a laboratory professional to choose from.
- Barcodes and bi-directional interfacing which reduces the manpower
costs in the laboratory operation.
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Technology in Thyroid Diagnosis
There are three laboratory technologies employed in Thyroid diagnosis and they
are Radioimmunoassays (RIA), Chemiluminescence Immunoassays (CLIA) and Enzyme
immunoassays (EIA). Though RIA is the mother of all the three technologies,
due to usage of Radioisotope (nuclear restrictions) the technology has lost
its place in the long run. Big laboratories use as on day, CLIA since this technology
provides a better quality due to its automation compared to RIA. Medium sized
laboratories use RIA in spite of the limitations of isotopes because they are
technically superior than the EIA methods. Unfortunately, even in EIA thyroid
testing is done and small laboratories find it a solution to give a local and
quick solution by using EIA. Statistics obtained from reagents supplier suggest
the ratio of technologies is 4:1:2 for CLIA: RIA: EIA in the industry.
Other Technologies involved in Thyroid diagnosis
Ultrasound is used widely to find out the echogenecity of the nodules in patients
with solitary or multinodular or diffuse goitres. The fear of malignancy forces
a screening for all goitres either by an ultrasound or by a radioscan. Radioscan
is done either using Iodine—131 or using Technicium—99m. But this
facility is available in limited institutes only. Fine Needle Aspiration Cytology
(FNAC) (this test is done by a pathologist) requires aspiration of cells from
the nodule under question and is processed in a laboratory and studied using
a microscope. This helps in confirming malignancy or ruling out, when it is
suspected. Last but not the least is a whole body scan which also done only
in specialised nuclear medicine centres for patients who are monitored for cancer
(secondaries) and this test confirms that the patient is free of thyroid tissue
in treated thyroid cancer patients.
E-mail: ceo@thyrocare.com
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