Page 181 - GSTL_21st May 2020_Vol 36_Part 3
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2020 ]               IN RE : DKMS BMST FOUNDATION INDIA              427
                                 KIR genes can be expected for approximately 85% of the sam-
                                 ples.
                            •    CMV (Cytomegalovirus) IgG antibody testing (blood  and
                                 swab based)
                                 The Cytomegalovirus is widely spread in Europe. In most cas-
                                 es the infection does not break out due to generation of anti-
                                 bodies against the virus. During immunosuppression a CMV
                                 infection can be dangerous to patients who never had contact
                                 to the virus.
                                 To detect anti-CMV-IgG, a sign of a previous or current CMV-
                                 infection, we perform an ELISA based on CMV surface protein
                                 coated micro titer-plates and anti-IgG conjugate. This assay
                                 delivers a positive or negative testing result for the sample. An
                                 ambiguous result which is not clearly positive or negative will
                                 be transmitted as “g” for grey-zone.
                                 Swab samples with insufficient sampling material (IM) will be
                                 cancelled. These samples will not be charged, if the total quan-
                                 titative share of such samples stays below 2.5%.
                                 Testing results for CMV from swabs can be obtained for >75%
                                 of samples. About 2% of samples are here detected as false
                                 negatives. Testing results for CMV from blood can be obtained
                                 for approximately 98% of samples.
                       5.3  HLA Testing qualifies to be a ‘service’ under GST Law :
                       5.3.1  The applicant states that outset, he wishes to state that as per the
               Section 2(52) of the CGST Act, 2017, goods means every kind of movable proper-
               ty other than certain exceptions. As per Section  2(102) of the CGST Act, 2017,
               “services” means anything other than goods, money and securities. It is pertinent
               to note than HLA testing is a test performed in laboratories on the physical sam-
               ples of swabs/Human DNA to maintain a list of potential donors and execute
               the process of donation in case the samples of donor and done matches. Thus, it
               is a  service  performed by laboratories on the samples and hence HLA testing
               would fall within the definition of “service” as per the CGST Act, 2017.
                       5.4  HLA Testing - an integral part in the treatment of blood cancer and
               other blood disorder.
                       5.4.1  Basis the background and above mentioned details, the applicant
               states that it is absolutely clear that the primary step of the donation process re-
               quired for treatment of blood cancer and other blood disorders is identifying a
               donor. Now, to identify a donor, samples of potential donors would be required
               to be tested to classify those into specific categories as prescribed in medical ter-
               minology.
                       5.4.2  In the current scenario, the procedure of testing the samples of po-
               tential donors for further classification is entirely executed by LSL DE, Germany.
               The applicant states that it is pertinent to note that basis of such classification of
               HLA of potential donors into categories, the doctors, hospitals, transplant centres
               including the patients are able to conduct a search and find a suitable match. In
               case the said classification would not have been done, the patient would not have
               been able to find a suitable match in the limited life time available to them.
                       5.4.3  Further, the applicant reiterates that many patients suffering from
               blood cancer and other blood disorders need a blood stem cell transplant to sur-
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