Quyết định 1282/QD-BYT

DECISION

PROVIDING “PROVISIONAL INSTRUCTIONS FOR COVID-19 TESTING”

MINISTER OF HEALTH

Pursuant to the Government's Decree No. 75/2017/ND-CP dated June 20, 2017 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Upon the request of the Director of the General Department of Preventive Medicine, affiliated to the Ministry of Health,

HEREBY DECIDES

Article 1. “Provisional Instructions for COVID-19 testing” shall be annexed to this Decision.

Article 2. “Provisional Instructions for COVID-19 testing” is an instruction manual available for use at establishments running laboratories nationwide.

Article 3. This Decision shall enter into force from the signature date.

Article 4. Mr./Mrs. Chief of the Ministry’s Office; the Ministry’s Chief Inspector; Directors or General Directors of Departments/Administrations/Authorities affiliated to the Ministry of Health; Directors of Institutes of Hygiene and Epidemiology, Pasteur Institutions, Directors of hospitals affiliated to the Ministry of Health; Directors of Departments of Health in provinces and centrally-controlled cities; Heads of Health Divisions of Ministries and sectoral administrations; and Heads of other entities concerned, shall be responsible for implementing this Decision./.

PROVISIONAL INSTRUCTIONS FOR COVID-19 TESTING

 (Annexed to the Decision No. 1282/QD-BYT dated March 21, 2020 of the Minister of Health)

COVID-19 is a Class-A acute communicable disease caused by a virus called SARS-CoV-2 (sometimes simply called coronavirus). This is a contagious disease that spreads from person to person. Its incubation lasts for about 14 days. Patients infected with this disease will develop typical symptoms, such as fever, cough, difficulty breathing, which may lead to severe acute respiratory infection, acute respiratory failure and eventually death. Older adults and people with pre-existing and chronic medical conditions might be at higher risk for severe illness from COVID-19. As several patients infected with SARS-CoV-2 might have mild and atypical symptoms, early detection of the disease seems to be a real challenge. Till now, drugs and vaccines for treatment and prevention of the disease have not yet been available for use.

As reported till date, COVID-19 cases have been found in more than 180 countries and territories. On seeing its spread at that time, WHO declared COVID-19 a global pandemic on March 11, 2020.

In Vietnam, 90 cases have been reported throughout Northern, Central Coast and Southern regions, including cases entering from various countries and other secondary infection cases.

These provisional instructions shall be applied on a nationwide scale.

I. GENERAL PROVISIONS

1. Testing purposes

- Diagnosis of infection with SARS-CoV-2

- Epidemiological surveillance of COVID-19

2. Testing principles

- Laboratories must comply with clinical test procedures and approaches according to instructions given by diagnostic test kits and warnings of WHO/USCDC.

- Testing quality and biosafety must be assured.

3. Testing techniques

- Molecular biotest (Realtime RT-PCR) which is used for detecting coronavirus ARN from respiratory samples.

- Quick tests on clinical respiratory and blood samples.

- Immunological tests (ELISA, etc.) on clinical respiratory and blood samples.

4. Laboratory requirements

4.1. Laboratories conducting confirmatory tests:

- They must be furnished with facilities, equipment and means properly designed for Realtime RT-PCR tests. (See the chart of equipment given in Appendix 1 hereto)

- Their staff must be trained in testing techniques and biosafety.

- All laboratory units must conform to biosafety Level-2 requirements or must have built-in negative pressure rooms designed for biological sample separation.

- They must obtain certification of competency in conducting confirmatory tests granted by Institutes of Hygiene and Epidemiology or Pasteur Institutes in charge.

4.2. Laboratories conducting screening tests:

- They must be fully furnished with facilities, equipment and means properly designed for tests.

- Their staff must be trained in testing techniques and biosafety.

- They must provide technicians with adequate protective equipment, and must take action to protect their safety.

 (See the chart of equipment given in Appendix 2 and 3 hereto).

4.3. Test room units of laboratory facilities may be immovable or movable to meet various testing demands. Movable test rooms must be provided with equipment specified in Appendix 1, 2 or 3 hereto, depending on testing demands and capabilities.

II. REGULATIONS ON PERFORMING TESTS

1. Confirmatory testing

- It is recommended by WHO that molecular biotest technique must be used as a confirmatory test for Covid-19 infection cases.   

- Testing procedures must conform to guidance of World Health Organization (WHO) or the U.S. Center for Disease Control and Prevention (CDC).

- If a test result is positive, the testing facility must inform it to the local Steering Committee and report it to the national Steering Committee.

- If a test result is negative, the testing facility must inform it to the sample provider.

- Laboratory units (specified in the list given in the Appendix 4 hereto) shall be authorized to conduct confirmatory tests on COVID-19 infection cases.

2. Screening testing:

- Molecular biotest, quick test or other testing technique shall be used for performing screening tests.

- If the test result is positive, the clinical sample will need to be sent to a confirmatory testing laboratory to perform the confirmatory test.

- If the test result is negative, provisional instructions for surveillance, further actions must be taken in accordance with provisional Instructions for surveillance, prevention and control of COVID-19 annexed to the Decision No. 963/QD-BYT dated March 18, 2020 of the Ministry of Health must be observed.

III. IMPLEMENTATION PROVISIONS

1. COVID-19 testing facilities

- Undertaking collection, handling and preservation of clinical samples according to the Circular No. 40/2018/TT-BYT dated December 7, 2018 of the Ministry of Health, regulating management of clinical samples of communicable disease and the Decision No. 963/QD-BYT dated March 18, 2020 of the Ministry of Health.

- Performing all tests according to manuals provided by manufacturers and in conformance to quality standards and safety requirements.

- Carrying out data reporting under the provisions of the Circular No. 54/2015/TT-BYT dated December 28, 2015 of the Ministry of Health regarding instructions on implementation of regulations on reporting and declaration of illnesses and communicable diseases.

- Giving counsels to departments of Health under their control and other regulatory authorities to support provision of training courses, and oversee technical support within their remit.

2. Departments of Health of provinces and centrally-affiliated cities

- Directing, inspecting and coordinating implementation of COVID-19 testing within their ambit in order to ensure timeliness and effectiveness.

- Giving directions to testing facilities within their management so that their testing capacity is improved, providing training and re-training on COVID-19 testing techniques for their staff members.

- Collaborating with related regulatory departments or divisions in supporting and overseeing COVID-19 tests.

3. Institutes of Hygiene and Epidemiology and Pasteur Institutes

- Assessing and providing the Ministry of Health with counsels on implementation of testing methods according to specific surveillance strategies.

- Supporting testing facilities in strengthening and improving COVID-19 testing competencies.

- Providing training and technical support for in-charge staff members of COVID-19 testing facilities.

- Inspecting and overseeing COVID-19 testing facilities under their delegated authority.

APPENDIX 1

LIST OF ESSENTIAL EQUIPMENT DESIGNED FOR REALTIME RT-PCR TESTING
 (Annexed to the Decision No. 1282/QD-BYT dated March 21, 2020 of the Minister of Health)

This list excludes biosafety equipment. 

APPENDIX 2

LIST OF ESSENTIAL EQUIPMENT DESIGNED FOR IMMUNOLOGICAL TESTING
 (Annexed to the Decision No. 1282/QD-BYT dated March 21, 2020 of the Minister of Health)

This list excludes biosafety equipment. 

APPENDIX 3

LIST OF ESSENTIAL EQUIPMENT DESIGNED FOR RAPID TESTING
 (Annexed to the Decision No. 1282/QD-BYT dated March 21, 2020 of the Minister of Health)

APPENDIX 4

LIST OF LABORATORIES/TESTING FACILITIES OBTAINGING MINISTRY OF HEALTH'S LICENSE TO CONDUCT COVID-19 COFIRMATORY TESTS*
 (Annexed to the Decision No. 1282/QD-BYT dated March 21, 2020 of the Minister of Health)

1. National Institute of Hygiene and Epidemiology;

2. Ho Chi Minh city’s Pasteur Institute;

3. Nha Trang Pasteur Institute;

4. Central Highland Institute of Hygiene and Epidemiology;

5. Hanoi Center for Disease Control and Prevention;

6. Da Nang Center for Disease Control and Prevention;

7. Can Tho Center for Disease Control and Prevention;

8. Yen Bai Center for Disease Control and Prevention;

9. Lao Cai Center for Disease Control and Prevention;

10. Quang Ninh Center for Disease Control and Prevention;

11. National Hospital for Tropical Diseases;

12. Ho Chi Minh city Hospital for Tropical Diseases;

13. Cho Ray Hospital;

14. Thai Nguyen National General Hospital;

15. Hue National General Hospital;

16. National Hospital of Pediatrics;

17. Phu Tho General Hospital;

18. Bach Mai Hospital;

19. Hospital of Pediatrics No.1;

20. Military Institute of Preventive Medicine;

21. Joint Russian – Vietnamese Tropical Center;

22. 108 Military Central Hospital;

* This list will be updated with new laboratories/testing facilities posted on the Ministry of Health’s website.