MINISTRY OF
HEALTH
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|
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 1282/QD-BYT
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Hanoi, March 21,
2020
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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.
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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./.
PP. MINISTER
DEPUTY MINISTER
Nguyen Thanh Long
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.
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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.
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- 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.
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- 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.
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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.
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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.
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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)
No.
Description
Quantity
1
Realtime PCR result magnification and analysis
components of the following systems:
- Applied Biosystems (ABI) 7500 Fast Dx
Real-Time PCR instrument;
- Applied Biosystems ViiA7 instrument;
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- Mx3000P QPCR System (Agilent Technologies) ;
- iCycer IQ5, CFX96n (Bio-Rad Laboratories);
1
2
Centrifuges
1
3
Mixers
1
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10 μL, 20μL, 200μL, 1000μL pipette sets
1
5
Refrigerators for storage of chemicals and test
kits
1
6
Timers
1
7
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1
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)
No.
Description
Quantity
1
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1
2
Centrifuges
1
3
Mixers
1
4
10 μL, 20μL, 200μL, 1000μL pipette sets
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5
Refrigerators for storage of chemicals and test
kits
1
6
Timers
1
This list excludes biosafety equipment.
APPENDIX
3
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No.
Description
Quantity
1
Refrigerators for storage of chemicals and test
kits
1
2
Timers
1
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Sampling kits and other consumables
Varying depending
on the number of tests to be conducted
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;
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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;
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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.