Private hospitals mandatory to obtain approval for TrueNat

Registered private labs and hospitals allowed to charge INR 1500 per test

Dimapur, Aug. 1 (EMN): The directorate of Health and Family Welfare has informed that private labs and hospitals have been permitted to install TrueNat and CNBAAT for Covid-19 testing, subject to mandatory criterion for obtaining National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation and approval or registration under ICMR.

It informed that this is primarily to ensure high quality testing and ensure correct interpretation of test results and also to improve the overall quality of private labs and hospitals.

Registered private labs and hospitals within the state have been allowed to charge an amount of INR 1500 per test from the patient(s) for Covid-19 testing through TrueNat, which is subject to revision from time to time.

Further, as recommended by the ICMR, private labs and hospitals are free to test any individual in accordance with the ICMR guideline.

Necessary guideline can be downloaded from ICMR website.

Private hospitals permitted to use rapid antibody test

Private hospitals registered under NHCE Act 1997 are permitted to use rapid antibody test as point of care (PoC) for Covid-19 testing subject to fulfilment of the advisory.

The permission was granted through a notice dated July 30, issued by the government/ ICMR from time to time, a DIPR report stated.

According to the department of Health and Family Welfare, interested hospital/ labs initiating testing through the rapid antigen PoC test are to mandatorily register with ICMR for data entry into the ICMR portal on a real time basis. Such hospitals/ labs are to send their details to the state nodal officer for Covid-19 testing addressing to Dr. Robin Lotha, joint director, by email to stonu@rntcp.oru and to contact mobile phone No: 81190 00484 for any queries.

Registered private hospitals within the state are allowed to charge an amount of 15% above MRP plus GST per test from the patient for Covid-19 testing through rapid antigen test, the report stated.

It further stated that only ICMR validated rapid antigen test should be used. The details of validated test kits list of companies/ vendors of rapid antigen test kits for Covid-19 could be downloaded from ICMR website.

Advisory on rapid antigen test

ICMR has approved use of rapid antigen test for quick detection of Covid-19 patients and accordingly the following guidelines are to be strictly adhered to by all users:

1. Only ICMR validated rapid antigen test shall be used. The details of validated test kits list of companies/ vendors of rapid antigen test kits for Covid-19 can be downloaded from ICMR website.
2. As recommended by ICMR, the deployment of the rapid antigen point of care (PoC) test for Covid-19 testing is permissible in the following setting:

• All containment zones identified by the state governments.
• All central and state government medical colleges and government hospital.
• All private hospitals approved by national accreditation board for hospitals and healthcare (NABH).
• All private labs accredited by National Accreditation Board for Laboratories (NABL) and approved by ICMR as Covid-19 testing labs.

1. A positive test should be considered as a “true positive” whereas all symptomatic cases testing negative through rapid antigen test should be confirmed with a real-time PCR test. The detail advisory can be downloaded from ICMR website.
2. Rapid antigen PoC test is recommended for use subject to the following conditions:
   (a) All hospitals, labs, State governments intending to perform the PoC antigen test need to register with ICMR to obtain the login credentials for data entry. Interested Institutions may send their request on the following email ids:
   • For government hospitals: ag-govthosp@;icmr.gov.in
   • For private hospitals: ag-pvthosp-nabh@.icmr. gov. in
   All data of testing needs to be entered into the ICMR portal on a real time basis.
   All labs/hospitals initiating testing through the rapid antigen PoC test need to ensure that all symptomatic negative patients should be essentially referred to a real-time RT-PCR test for Covid-19. This is particularly essential as the rapid antigen PoC test has a moderate sensitivity.
   All the entities using antigen PoC test are expected to tie up with the nearest RT-PCR Covid-19 testing lab to ensure that all symptomatic who are negative by the rapid antigen test get tested at the nearest facility.
   The data of individuals tested by RT-PCR will need to be entered through the lab performing the RT-PCR test.
3. All hospital/ labs initiating testing through the rapid antigen PoC test are to mandatorily register with ICMR for data entry into the ICMR portal on a real time basis and are to send their details to the State Nodal Officer for COVID-19 Testing, Dr. Robin Lotha, Joint Director by email to stong@jntcp.org and to contact mobile phone No. 8119000484 for any queries. Detailed video is available on ICMR website.
4. Registered private hospitals within the state would be allowed to charge user’s fee for Covid-19 testing through rapid antigen test at the rate fixed by the government.
   The statement, however, stated that the advisory would be subjected to revision from time to time.