DECISION

ISSUING THE NATIONAL GUIDELINES FOR HIV TESTING

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;

Pursuant to the Law on HIV/AIDS prevention and control;

Pursuant to the Government’s Decree No. 75/2016/ND-CP dated July 1, 2016 prescribing conditions for HIV testing;

Upon the request of the Director of the Vietnam Administration for HIV/AIDS Control,

HEREBY DECIDES

Article 1. “National Guidelines for HIV Testing” shall be issued together with this Decision.

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Article 3. This Decision shall replace the Decision No. 1098/QD-BYT dated April 4, 2013 of the Ministry of Health regarding promulgation of the national guidelines for HIV serology testing; the Decision No. 1053/QD-BYT dated April 2, 2010 of the Ministry of Health regarding promulgation of the guidelines for HIV testing for children under 18 years of age; the Decision No. 868/2005/QD-BYT dated March 29, 2005 of the Ministry of Health regarding promulgation of 07 sample reports used in testing laboratories.

Article 4. The Chief of the Ministry’s Office, Heads, Directors or General Directors of Departments, Administrations and General Departments, Heads of affiliates of the Ministry of Health, Directors of Departments of Health of provinces and centrally-affiliated cities, and Heads of relevant entities, shall be responsible for implementing this Decision./.

PP. THE MINISTER
THE DEPUTY MINISTER




Nguyen Thanh Long

NATIONAL GUIDELINES FOR HIV TESTING

(Issued together with the Decision No. 2674/QD-BYT dated April 27, 2018 of the Minister of Health)

Part I

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1. This Decision deals with the following issues

1.1. HIV testing techniques: HIV serological and molecular biological testing techniques

1.2. HIV testing quality assurance.

2. Testing purposes

2.1. Ensure safety for blood transfusion, human tissue or organ transplantation and artificial insemination.

2.2. Surveillance of the HIV/AIDS epidemic: carry out the time and location-specific measurement of the HIV prevalence in certain populations with the intention of monitoring the distribution and developmental trends of the epidemic to provide information for formulation of HIV/AIDS prevention and control plans and assessment of HIV/AIDS prevention and control measures.   

2.3. Diagnosis and detection of HIV infection: determine the status of HIV infection of the test takers.

3. Testing principles

3.1. Ensure the HIV testing is confidential and voluntary.

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3.3. Comply with testing strategies, algorithms and procedures.

3.4. Ensure the testing quality and biosafety.

3.5. Create connections to prevention, treatment and care programs.

4. Classification of HIV testing methods and techniques

Tests for HIV infection are divided into the following main testing methods:

4.1. HIV serological testing method is intended for detecting the presence of HIV antibodies and/or HIV antigens in the blood or in the body fluids to determine the HIV status of adults and children older than 18 months of age. This method includes the following techniques:

- Simple technique;

- Immunoassay technique;

4.2. The molecular biology testing method is intended for detecting the presence of HIV DNA/ARN in the blood or in the body fluids.

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Part II

HIV TESTING INSTRUCTIONS

Chapter I

SEROLOGICAL TESTING

Section 1. Testing strategies, algorithms and test kits

1. Testing strategies

HIV serological tests are conducted according to different strategies depending on testing purposes and HIV prevalence in the tested population.

The diagram showing the implementation of testing strategies shall be subject to regulations laid down in the Appendix 1 to these instructions.

1.1. Strategy I:

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- A specimen is considered reactive to the strategy I if that specimen is reactive to a test in which a test kit is of high sensitivity.  The test kit used in blood screening tests shall be subject to regulations set forth in Section 3, Chapter I of these guidelines.

1.2. Strategy II:

- This is applied to the surveillance of the HIV epidemics.

- A specimen is deemed as positive to the strategy II if that specimen is reactive to both of test kits having different principles or antigen preparations. The test kits used in tests for the surveillance of HIV epidemics shall be subject to regulations set forth in Section 3, Chapter I of these guidelines.

- The results of this test only serve the purposes of epidemic surveillance and are not used for informing the test taker.

- The test results shall be informed to the test takers only in case of the test carried out by using the third test kit in accordance with regulations laid down in the strategy III.

1.3. Strategy III:

- This is applied to the diagnosis of HIV infection.

- A specimen is deemed as positive to the strategy III if that specimen is reactive to three types of test kit having different principles or antigen preparations. The test kits used in tests for the diagnosis of HIV infection shall be subject to regulations set forth in Section 3, Chapter I of these guidelines.

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- Testing algorithm is a combination and order of tests carried out by using specific test kits which have been selected to meet requirements of each testing strategy.

- Order of tests carried out by using test kits selected in a testing algorithm should adhere to the principles stated hereunder: (i) the test kit used for the primary screening must have high sensitivity; (ii) supplementary test kits must have the highest specificity; (iii) selection of the test kits having similar disadvantages such as false negatives or false positives, in the same algorithm.

- A testing algorithm is selected depending on (i) testing purposes, (ii) sampling size, (iii) requirements concerning the test response time, and (iv) specific conditions and actual capacity of the testing facility.

- The test kit used in a test should be selected according to the warning of the national HIV testing algorithm and the number of specimens to be tested at the testing facility.   Where the number of specimens is equal to or greater than 40 specimens/day, the immunoassay screening test algorithm should be used. Otherwise, if the number of specimens is less than 40 specimens/day, the screening test algorithm using the rapid test kit should be used.   

3. HIV testing kits

3.1. Test kits used for testing purposes (abbreviated as SP) must be approved for used by the Ministry of Health.

3.2. HIV testing kits must meet the following standards:

- Test kits used to ensure safety for the blood transfusion must comply with regulations on the blood transfusion safety.     

- Test kits used in HIV tests conducted according to the strategy II and III must have the following characteristics:

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Description of the characteristics of the test kit used in a test¹

Minimum requirements

1

Sensitivity

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Test kits for screening purposes (SP1)

≥ 99.5% as for the rapid SPs

100% as for the immunoassay SPs

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Supplementary test kits (SP2, SP3)

≥ 99.5% as for the rapid SPs

100% as for the immunoassay SPs

2

Specificity

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Test kits for screening test purposes (SP1)

≥ 98% as for the rapid SPs and the immunoassay SPs

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Supplementary test kits (SP2, SP3)

≥ 99% as for the rapid SPs and the immunoassay SPs

- The sensitivity and specificity of the test kits used in tests are measured based on the results of the assessment of the quality of the test kit reported by the country or international bodies, such as World Health Organization, the US’s Centers for Disease Control and Prevention, the Australia’s National Laboratory (NRL) – the regional reference laboratory affiliated to WHO or other prestigious organizations.   

3.3. HIV testing kits must help detect HIV-1 and HIV-2 antibody and/or HIV antigen.

3.4. Storage and use of test kits used in tests must conform to the manufacturer’s instructions.

Section 2. HIV testing procedures

The procedures for carrying out HIV screening tests according to these guidelines shall not be applied to those tests conducted for maintenance of the blood transfusion safety.

I. Community-based screening tests

These tests shall be categorized into the followings:

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- Tests conducted by non-laboratory personnel.

- Tests conducted by laboratory personnel.

1. Self-testing

1.1. Definition: HIV self-testing is the process in which the test taker carries out all HIV testing steps on his/her own, including self-sampling, self-testing and self-reading of test results. 

1.2. Test procedures:

1.2.1. Collection of pathology specimens

a. Collecting oral fluid

- Do not eat or drink for at least 15 minutes before starting the test; Do not use mouth cleaning products 30 minutes before starting the test.

- Check the expiration date and the tamper-evident seal of the test stick and the testing solution.

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- Check the moisture absorbing packet inserted into the test stick pouch. If there is no moisture absorbing packet inside the pouch, do not use the test stick and use a new one instead.

- Place the test swab between the lower cheek and the outer gum, and gently swipe the test swab completely around the outer gums, both upper and lower, one time around. Do not swab roof of mouth, inside of cheek or tongue. Both sides of the sample collection swab may be used during this procedure.

b. Collecting the blood from the fingertip

- Preparing the test kit components: Disposable or single-use dedicated needles/lancets, capillary tubes designed with proper volume, gloves, sterile absorbent pads, 70% alcohol or iodine alcohol, bandages and waste containers in compliance with applicable regulations.   

- Preparing for the blood collection

+ Fill in all required information about the test taker (full name, identity code and birth year/age) and sample collection date on the test form and the test vial (where necessary).    

+ Wash hands and put on gloves.

- Collecting the blood

+ The test taker should warm his/her hand by rubbing two hands together or washing them with warm water;

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+ The test taker should incline the arm in a downward position;

+ Disinfect the insertion site with 70% alcohol and wait 30 seconds for the alcohol to dry; 

+ Place and then quickly and firmly press the needle/lancet at a perpendicular angle to the skin surface of the fingertip.   Ensure the blood collection needle is held at the correct angle without sloping;

+ Wipe away the first blood drop (because it may be contaminated with intracellular fluid that possibly skews the test results, or it may contain interstitial cells causing a lack of blood volume for the test); 

+ Wait for formation of large blood droplet, draw a necessary volume of blood in a capillary tube (avoid excessive pressure that may squeeze tissue fluid around the puncture site into the drop of blood that could adversely affect the sample quality); 

+ Put the needle/lancet into the sharp container and the capillary tube used for drawing blood sample into the medical waste disposal container;

+ Disinfect the prick site again with 70% alcohol and apply a bandage to the site; 

+ The collected blood sample must be tested according to the manufacturer’s instructions.

1.2.2. The test must be carried out according to the manufacturer’s instructions.

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Test results only serve primary screening purposes, are not used for diagnosis of HIV infection. In the case of the reactive result, it needs to be confirmed with HIV confirmatory tests in accordance with regulations issued by a healthcare service establishment.

2. Tests conducted by non-laboratory personnel

2.1. Definition: This kind of test is conducted by community service/medical personnel of a village/medical staff who do not major in testing and do not work for a HIV testing facility, but are trained in HIV testing. 

2.2. Test procedures:

Counseling and collection of samples for this HIV test must take place at clean, comfortable, well-lighted and private areas.

2.2.1. Collection of the pathology sample shall be subject to 1.2.1 clause 1.2 Section 1, Part I of this Chapter.

2.2.2. Implementation of HIV testing and test result discussion and interpretation shall comply with the manufacturer’s instructions.

2.2.3. Delivery of the test results

- If the test result is negative, the counseling and notification of the test result are delivered to the client.  

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3. Tests conducted by laboratory personnel

3.1. Definition: This refers to the test conducted by technicians of laboratories who have already completed HIV testing training courses. 

3.2. Test procedures:

Counseling and collection of samples for this HIV test must take place at clean, comfortable, well-lighted and private areas.

3.2.1. Collection of the pathology specimen

a. Collection of the oral fluid specimen or finger prick blood sample shall be subject to 1.2.1 clause 1.2 Section 1, Part I of this Chapter.

b. The venous blood sample or specimen shall be collected according to the following procedures:

- Preparing blood collection kits, including sterilized syringes and needles, vacutainer blood collection set (including vacutainer tube, needle and rack), disposable plastic pipette (bulb type), plastic test tubes with caps, test tubes containing an anticoagulant (whenever the plasma specimen needs to be collected), gloves, face masks, tourniquets, sterilized absorbent pads, 70% alcohol, highlighter pens (waterproof ink type), test tube racks, sharps containers and medical waste containers.    

- Preparing for the blood collection

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+ Wash hands and put on gloves.

- Carrying out the blood collection

+ Identify the puncture site (vein site) and disinfect the site with 70% alcohol and wait 30 seconds for the alcohol to dry. 

+ Insert the needle into the vein to draw 3 – 4 ml of blood in the blood sample collection tube.  The 5ml needle syringe (21G - 23G sized needle) may be used to collect blood or the blood collection vacutainer set may be used instead.    If the syringe is used for collecting blood, the needle should be removed and place the syringe to form an appropriate angle with the test tube and gradually flow blood down along the inner wall of the tube to avoid red blood cell destruction and damage. 

+ Dispose the needle into the sharps container, and the syringe or the blood collection tube holding rack which has been used and dirtied into the medical waste disposal container;

+ Disinfect the puncture site again with 70% alcohol and apply a bandage to the site. 

- Blood serum/plasma separation:

+ After collection, allow the blood sample to clot between 30 minutes and no longer than 2 hours at room temperature, and then carry out the blood serum/plasma separation.    If it is impossible to separate blood serum/plasma within 2 hours, wait another 30 minutes for the blood sample to clot, then store it at temperature ranging 4^oC - 8^oC, and in this case, the blood serum/plasma needs to be separated within 24 hours.    

+ In case of use of a centrifuge, all test tubes must be kept balanced before commencement of the centrifugation.  Carry out the centrifugation at the speed of 2,000 – 2,500 rpm in 10 minutes.  Use a plastic pipette to separate blood serum/plasma into a plastic tube before the cap is tightly snapped.

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+ The minimum volume of blood serum/plasma to be collected is 1.5ml.

3.2.2. Implementation of HIV testing and test result discussion and interpretation shall comply with the manufacturer’s instructions.

3.2.3. Delivery of test results

- If the test result is negative, counseling and notification of the test result are delivered to the client. 

- If the test result is reactive, collect the client’s blood, recommend a medical facility in order for the client to take the HIV confirmatory test, or give counseling and set an appointment with the client to deliver the test result.

3.3. HIV testing quality assurance

- Follow the manufacturer’s instructions for collection of the blood sample, implementation of the test and reading of the test result.

- The HIV testing location needs to be clean, well-lighted, built on level ground and easily disinfected.

- 3.4. Storage and use of test kits must conform to the manufacturer’s instructions. In case of storage of test kits at room temperature, a thermometer needs to be installed to monitor temperature inside the storage room to prevent the temperature exceeding the permissible range.

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- Read the test result only when it is produced after the prescribed amount of time, and there is one line appearing in the control region.   

3.4. Biosafety:

- Provide biosafety instructions for all testing personnel.

- The testing personnel should be provided with appropriate protective equipment when collecting samples and performing tests.

- Wash or disinfect hands right after taking off gloves and ending the test procedures.

- Carry out decontamination of the test area using appropriate decontaminants.

- Sort and collect wastes discharged from sample collection and test implementation activities into proper waste containers and transport them to medical facilities for disposal in accordance with regulations in force.

- Make and comply with regulations on response to any emergency or incident occurring during the process of sample collection and test implementation, such as insertion of sharp objects into hands and spillover of pathology specimens. 

II. HIV screening tests performed at healthcare facilities

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1. Collecting, transporting, storing and eliminating test specimens.

1.1. Collection of samples or specimens shall be subject to 3.2.1 clause 3.2 Section 3 Part I of this Chapter.

1.2. Transport of samples or specimens

1.2.1. Packing samples or specimens:

- Use three layers of packaging to contain samples or specimens

+ Primary layer of packaging (sample containing tubes): Wear gloves to tightly cap sample tubes and arrange all test tubes in the vertical direction in the rack. Use adhesive tape to fix sample tubes on the rack (where necessary).

+ Secondary layer of packaging (including bags, boxes and packets made from materials which are durable, waterproof, anti-leak and resistant to temperature ranging from 40-55^oC): Insert an adequate amount of absorbent materials (such as absorbing swab or blotting paper) between the primary layer and the secondary layer in order to absorb all samples in case of spillover or falling.  

+ Outermost layer of packaging (stiff, anti-collision and anti-leak boxes or containers).  Insert cold packets between the secondary layer and the outermost layer to store samples at the temperature ranging from 4^oC to -8^oC during transportation. In case of transport of the samples at the deep-freeze temperature, it should be necessary to use dry ice during transportation. In case of using dry ice, the outermost layer of packaging needs to have holes for discharge of CO2. 

- Close the sample container with caps and lock it. In case there is no lock, the adhesive tape may be applied around the container.

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- Note: Do not place the manifest of samples inside the sample transporting container.

1.2.2. Transport of samples or specimens

- Transporting specimens or samples must conform to national and local regulations regarding carriage of pathogens.

- Inform the receiving laboratory in advance of the arrival of the specimen so that the laboratory assigns its staff to receive it.

- The specimen is transported along with the test request form on which all required information have been completely filled in.

- The specimen must be stored at cold temperature during transportation.

- During the process of transportation of the specimen, tightly fasten the specimen containing box to the transport rack, ensure tidiness and avoid spillover and falling risks.

1.2.3. Receipt of the sample

- Check the temperature inside the transport box, check the conditions of the sample and compare the sample with the information given on the blood containing tube and the test form. If there is any variation between the information provided on the test form and those described on the test tube, the sample sender needs to confirm which information is correct, or decide that the test results will be informed and delivered based on the information displayed on the test tube.

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- Require the sample sender to provide additional information if the information about address, date of collection of the sample required on the test form are not complete.  

- Sign the note of delivery of the sample and enter the information about the sample size, recipient and receipt time in the sample receipt registry.

1.3. Storage of the sample

- The blood serum/plasma sample, if being tested within 3-7 days, must be stored at the temperature ranging from 4^oC - 8^oC (depending on the manufacturer’s instructions).  For longer storage, the sample must be stored at the temperature of - 20^oC or colder temperature.  However, thawing of the blood sample shall be restricted to no more than 3 times.

1.4. Destruction of the blood sample

Destruction of the blood sample shall comply with regulations laid down in the Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Ministry of Health and the Ministry of Natural Resources and Environment on medical waste management.

2. Performing the test

2.1. Diagram of HIV testing procedures

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- Each test kit needs to have corresponding procedures written in Vietnamese language. 

- Test kits and specimens must be stored at the temperature as recommended in the manufacturer’s instructions.

- As for test kits without including sample collection instruments, a pipetman must be used for drawing the sample.

- Design the testing diagram/the lab activity form for each test activity.  The test diagram describes the information about test kits, batch number, expiry date, test performing date, management of the control sample and sample testing results.

- Use personal protective equipment when working inside the laboratory.

- Perform the test according to the manufacturer’s instructions.

- Perform the test at the test desk which is easily cleaned by using disinfectants, is well-lighted and airtight. Floor, walls and test desks must be built on level ground, waterproof, resistant to high temperature and corrosive chemicals, and easily cleaned.

- Use the countdown alarm timer specially designed for tests to read the test result

- Read and discuss the test results only when the control sample meets the manufacturer’s requirements. In case where the internal control sample is used, in addition to obtaining the accreditation from its manufacturer, it must satisfy the predetermined requirements before the discussion and interpretation of the results produced after testing of that sample.  

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- The tested sample sent to the confirmatory test laboratory must be stored in the refrigerator at the temperature ranging from 4^oC - 8^oC if it is transported within a period of 3-7 days. Unless it is transported within that period, the sample needs to be stored at the temperature of -20^oC.

- Show the test result in the test diagram/the lab activity form.

- Enter the test result into the test record book and make delivery of the test result. 

2.3. Performing the immunoassay/chemiluminescent immunoassay/ electrochemiluminescence immunoassay technique.

- Establish the procedures for use of each test kit, written in the Vietnamese language. 

- Test kits and specimens must be stored in refrigerators at the required temperature.

- Design the testing diagram before each test activity.  The test diagram describes the information about test kits, batch numbers, expiry date, test performing date and performer.

- Use personal protective equipment when working inside the laboratory.

- Carry out the pre-test inspection of the sample. In case there is a sign of fibrin or interlacing thread in the blood sample, the blood sample tube must be centrifuged before test. The centrifuge equipment must be suitable for test tubes and have the centrifugation speed of 3,000 – 3,500 rpm in 10 minutes.

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- Perform the test at the test desk which is easily cleaned by using disinfectants, is well-lighted and airtight. Floor, walls and test desks must be built on level ground, waterproof, resistant to high temperature and corrosive chemicals, and easily cleaned.

- Strictly follow the manufacturer’s accreditation requirements.

- When performing tests, testing instruments need to be cleaned in the deep clean basin having the depth of at least 30cm, made of waterproof materials and resistant to corrosive chemicals;

- Immunoassay/chemiluminescent immunoassay/electrochemiluminescence immunoassay systems must be stored under dry conditions by using air-conditioners or dehumidifiers.

- Use the countdown alarm timer designed for testing activities to read the test result.

- Read and discuss the test results only when the control sample meets the manufacturer’s requirements. In case where the internal control sample is used, in addition to obtaining the accreditation from its manufacturer, it must satisfy the predetermined requirements before the discussion and interpretation of the results produced after testing of that sample. 

- Infectious wastes that are released during implementation of the test must undergo processing before being moved into the concentrated waste disposal site in accordance with regulations in force.

3. Test result discussion, interpretation and test result notification and delivery

- If the test result is negative, the counseling is provided and notification of the negative test result is delivered to the client. 

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4. Completing forms and administering data

- The test laboratory performs the HIV screening test based on the test result indicated in the test diagram/the lab activity form, and enter the screening test result into the test record book. 

- The information available in the test record book must include but not limited to the followings: administrative information (full name, age, sex, address and state management classification of the test taker), sample collection date, test date, quality control results of test kits used, conclusions about sample conditions, confirmatory test results given by the confirmatory test laboratory.   When necessary, see the sample forms or books given in the appendix IV-A.

- Test results should be filed in accordance with regulations in force, and shall be prevented from any erasure.

- The officer in charge of the test laboratory shall be responsible for checking all test information and test documents before signing the test results.

- Test documents must be stored for a period of 5 years. After such period, if these documents need to be eliminated, the elimination report should be prepared.

5. Carrying out the test quality control and assurance

5.1. Pre-test phase

- The test laboratory needs to establish the standardized procedures for collection, packaging, storage and transport of the specimen and other regulations regarding standards for acceptance and refusal of the specimen as well as basic requirements concerning sample volume, sample quality, anticoagulant type, temperature, storage duration and information available on test tubes and test request form.   Only samples that meet prescribed requirements shall be accepted. Test procedures need to be concise and appropriate for the laboratory’s operations and conform to regulations of the Ministry of Health, and must be displayed in conspicuous places.

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- Instructions for use of test kits must be written in the form of standardized procedures.

5.2. During-test phase

5.2.1. Test kits and consumables.

- Only use test kits before their “use by” date, the expiry date specified on their packaging or the best-before date after opening or mixing with reagents.  

- In each test, only use test kits contained in the same pack or having the same batch number.  Always check test kits, chemicals and supplies upon receipt, pay attention to integrity, storage temperature and expiry date of test kits, chemicals and supplies.

- Before each use, careful observation is needed. If there is any unusual sign, such use is suspended, reasons must be determined and informed to the supplier.

- The logbook for management of test kits and supplies should be in use to prevent use of those which have expired.

5.2.2. Test equipment

- Test equipment should be administered by the monitoring documents, including post-installation documents, delivery and receipt reports, equipment datasheets and equipment usage logsheets (with regard to cold equipment, the equipment logsheet is a sheet used for recording daily temperature). There must be the procedures for use of equipment, written in the Vietnamese language, and the noticeboard of instructional manuals for use of equipment placed in easily accessible places.

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5.2.3. Facilities

- Test areas must be tidy, clean and spacious enough for tests to be performed.

- There must be biological hazard signs displayed at the entrance/exit door.

- First aid toolkits and emergency eye washing instruments, and clean water, must be available when necessary for immediate use.

- Equipment and machinery installed inside the laboratory need to be connected to the earthing devices.

- Fire fighting and prevention equipment must be subject to regular inspections.

- Wastes need to be dumped into medical waste disposal containers and undergo the prescribed disposal procedures.

5.2.4. Personnel

- Test personnel should be offered annual opportunities for test training, knowledge improvement education and competency assessment.

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5.2.5. Implementation of test activities 

- There must be all required test procedures available for use at each laboratory. It shall be necessary that a signboard displaying concise instructions for tests should be placed in easily visible places.  These procedures should be promptly updated upon receipt of the manufacturer’s notification and shall be subject to annual reviews.

- Comply with approved procedures.

- While the test takes place, compare the information displayed on the sample testing stick with the information displayed in the diagram sheet. 

- Comply with testing strategies and algorithms.

5.3. Post-test phase

- Test results need to be recorded in the test record book and subject to the review conducted by the authorized person.

- Test documents and test results of the client need to be scientifically managed to ensure confidentiality and easy traceability wherever necessary.

5.4. Supervision and quality assurance

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- Strictly follow the manufacturer’s control sample requirements and encourage internal control sample testing procedures. The frequency at which the internal control sample testing procedures are implemented depends on the sample size of each laboratory.

- Obtain the certificate of participation in the external control program:

+ Fully participate in the program in compliance with regulations in force.

+ Carry out the external quality control sample testing procedures like the conventional sample ones and deliver the test results to the supplier of the sample within the requested duration.

+ Upon receipt of the reactive test result, it shall be necessary to take a look at the external control result.  In case the latter is not proper, causes and corrective measures should be considered.

- Carry out technical assistance supervision:

+ HIV/AIDS control centers/bodies assigned HIV/AIDS control roles and duties in provinces shall conduct technical assistance periodical or ad-hoc inspection and supervision of screening test laboratories within their jurisdiction at least once a year.

+ Test facilities carry out cross inspections or internal inspections on a yearly basis.

6. Laboratory biosafety

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- Staff members directly in charge of tests and persons assuming responsibility for biosafety must be trained in biosafety.

- Other staff members working within testing sites must be provided with biosafety instructions suitable for their work position. 

- Have testing site entrance/exit regulations.

- Have plans for assessment of potential biosafety risks at test facilities and develop biosafety contingency and emergency response plans.

- Do not use mouth pipettes and syringes instead of pipettes; used needles and syringes must be discarded into appropriate sharps containers or needle destructors; avoid bending, fracturing or recapping needles.  

- Wash hands before leaving the laboratory room or promptly after contact with chemicals.

- Wear protective suit, toe cap shoes and boots when working inside the laboratory; do not wear protective suits in the public areas.

- Use gloves in case of direct contact or risks of direct contact with infectious substances. After use, take off gloves properly and wash hands.

- Do not mingle protective suits with normal clothes.

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- Do not use laboratory equipment to store or process foods.

- Do not eat, smoke, shave or use cosmetics inside the laboratory room.

- Disinfect the surfaces of work desks right after completion of each test, at end of working day or whenever the spillover or leakage of the specimen containing pathogens occurs.

- Sort, transport and dispose of wastes in accordance with regulations in force.

III. Tests for diagnosis of HIV infection

Personnel, physical materials, equipment and competency requirements should conform to the Government's Decree No. 75/ND-CP dated July 1, 2018 prescribing HIV testing conditions.

1. Collecting, transporting and storing specimens: Collection of samples shall be subject to regulations laid down in Section 1 Part II of this Chapter.

2. Performing the test

2.1. Diagram of testing procedures

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2.2. The test for diagnosis of HIV infection shall be carried out by employing the simple testing technique subject to 2.2. Section 2 Part II of this Chapter.

2.3. The test for diagnosis of HIV infection by employing the immunoassay/chemiluminescence immunoassay/electrochemiluminescence immunoassay shall be subject to 2.3. Section 2 Part II of this Chapter.

2.4. Sample retention and storage

- Samples testing HIV positive or indeterminate should be retained and stored for at least 2 years from the date of the confirmatory test at the temperature of -20^oC or colder. Upon expiration of the storage duration, if the test facility wishes to destroy the sample, the sample destruction report shall be made and deposited in accordance with regulations in force.

- Test tubes used for containing samples at the freezer temperature must be those designed with screw-caps.   Test tubes are neatly stowed in appropriate containers. Legibly write the information about the sample on the test tube by using unerasable ink, or using freeze resistant labels.

- For storage, samples must have codes and be recorded in the sample storage logbook in accordance with regulations in force. 

3. Test result discussion, interpretation, test result notification and delivery

- Analysis and interpretation of the test results shall refer to the diagram of the strategy III in the appendix I.

- Delivery of the test results to the sample senders or patients shall comply with regulations in force.

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- The healthcare service provider must inform the test result to patients within the maximum duration of 72 hours after the official HIV confirmatory test result is produced.

4. Completing forms and administering data

- The test facility must perform the HIV confirmatory test after the test results are available on the test diagram/the lab activity form and the reading sheet, and these test results must be entered into the test record book under regulations laid down in the appendix IV-A in these guidelines.   

- Test results should be filed in accordance with regulations in force, and use of the correction pen for correcting any error shall be prohibited. In case of any error that may arise, cross out the error, rewrite the correct words and give the competent person's signature adjacent thereto.

- The officer in charge of the test laboratory shall be responsible for checking all test information and test documents before signing the test results informed to the client.

- The test documents must be retained and stored for a period of 5 years. After such period, if these documents need to be eliminated, the elimination report should be prepared.

5. Test quality assurance

The test quality assurance shall be subject to Section 5 Part II of this Chapter, and the following regulations:

5.1. Personnel:

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- HIV testing laboratory room officers should have knowledge about HIV testing techniques, test quality management and other related legal knowledge. 

5.2. Quality assurance supervision:

- The National Institute of Hygiene and Epidemiology, Pasteur Institute of Ho Chi Minh city, Pasteur Institute of Nha Trang city and the Institute of Hygiene and Epidemiology of Central Highlands shall carry out regular or ad-hoc technical assistance inspection and supervision of operations of test facilities which have already obtained the certificate of conformance to regulations on confirmatory tests for HIV positive test results within their jurisdiction once a year.

6. Laboratory biosafety

The laboratory biosafety shall be subject to regulations laid down in Section 6 Part II of this Chapter.

Chapter II

MOLECULAR BIOLOGY TEST

I. Early diagnosis of HIV infection in infants and children aged under 18 months

1. Persons eligible for the diagnosis of HIV infection

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- Infants and children aged under 18 months who have clinical signs or symptoms of HIV infection, and receive positive anti-HIV antibody screening test results.

2. Competence in performing the test for the early diagnosis of HIV infection in infants and children aged under 18 months

The test laboratory must be assessed by the Ministry of Health or a competent authority and obtain the certificate of conformance to regulations on eligibility for HIV testing by using the molecular biology technique in infants and children under 18 months of age.  

3. Implementation procedures

The early diagnosis of HIV must be made promptly when children pay the primary visits to medical establishments. In this case, consultancy, diagnosis, care, prophylactic and therapy procedures shall be subject to the national guidelines for HIV/AIDS diagnosis and treatment.  

3.1. Pre-test counseling, prescription for the test and filling in necessary information.

3.1.1. Counseling: Carry out pre-test counseling under current HIV/AIDS diagnosis and treatment guidelines.  The counseling for the test should pay attention to the followings:

- Benefits of the early diagnosis of HIV infection and the sampling method;

- The number of tests to be performed and the duration of test result notification and delivery;

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3.1.2. Prescription for the test shall conform to the current national guidelines for HIV/AIDS diagnosis and treatment.

3.1.3. Filling in necessary information:

Fill out all required information in the “Test form for the early diagnosis of HIV infection in infants and children under 18 months of age" and "Form of delivery of the sample for the test for the early diagnosis of HIV infection in infants and children under 18 months of age" as provided by law (Form No. 1 and Form No. 2 in the Appendix IV-C). 

3.2. Sample collection, transport and storage

3.2.1. Sample collection and transport:

- The sample used in the molecular biology test may be either the dried blood spot (DBS) on blotting paper or the full blood prevented from clotting by the anti-coagulant EDTA (Acid Ethylene Diamine Tetra Acetic).

- Collect the blood sample by using the DBS collection toolkit or the toolkit intended for collection of the full blood with EDTA under prescribed safety conditions.  

- Fill out all required information into the sample delivery form and the test form according to the Appendix IV-C, Form No.1 and No. 2.

The procedures for blood sample collection, packing, transport and receipt of DBS and/or the full blood shall be prescribed in detail in the Appendix II and III.

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Upon receipt of the sample, the test provider should:

- Check the physical conditions of the sample and examine the consistency between information on DBS/blood tubes and test form. If there is any discrepancy between the information provided on the test form and those available on DBS/blood tube, the sample sender needs to confirm which information is correct, or decide that the test results will be informed and delivered based on the information displayed on DBS/sample tube.

- Inform the sample sender of taking the sample back if that sample does not satisfy the prescribed requirements:

+ The full blood or plasma sample is hemolyzed, is short of the prescribed volume, is prevented from clotting by using Heparin, is collected and transported to the laboratory room longer than 8 hours, is stored and transported at the temperature in violation of the regulations laid down in the Appendix III.

+ DBS sample is too small to be used in the test, is not dry, is contained on damp blotting paper, is infected with fungi, or is collected without complying with the scabbing technique (refer to the appendix II).

- Require the sample sender to provide additional information if the information about address, date of collection of the sample required on the test form are not complete. 

3.2.3. Sample storage:

- If the full blood sample is not immediately dropped onto DBS blotting paper, it must be stored in the refrigerator at the temperature ranging from 2^oC to 8^oC, and finish dropping onto DBS paper or must be tested within 8 hours after the sampling time.

- The blood plasma sample needs to be stored inside the deep freezer at the maximum temperature of -70^oC until the test is performed.  

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3.3. Implementation of the test: 

- Perform the test for the early diagnosis of HIV infection by employing the PCR technique conforming to the manufacturer's instructions and equipment meeting the requirements of the test kit used.

- The test kit used in the test for the early diagnosis must have the valid circulation number or must be approved for use by the Ministry of Health, and must remain unexpired.  The test kit used must be stored in conformity with the manufacturer’s instructions.

- Sample preparation and processing activities must take place inside the level-II biosafety cabinet.

- Each test area must have separate instruments and equipment to avoid cross contamination occurring during the test, including refrigerators, deep freezers, pipette sets, cold centrifuges fitting with test tubes used in each test stage, mixers, shakers and steam sterilizers.   

- Use the countdown alarm timer designed for testing steps that require the time count.

- Use appropriate personal protective suits when working inside the laboratory room.

- Store the specimen inside the deep freezer at the maximum temperature of -20^oC as per regulations in force for the minimum duration of 2 years in case of the HIV-positive specimen, and the minimum duration of 06 months in case of the HIV-negative specimen after the test is completed.

- Labels attached to specimens must be waterproof and freeze-resistant to avoid being spoiled at the freeze temperature.

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4.1. Time of test result notification and delivery

- The PCR test result needs to be informed and delivered to the test prescribing facility within a period of 02 weeks from the date on which the test laboratory receives the sample.

- In case of failure to do so, the test laboratory should inform the test prescribing facility of the reasons and the deadline for notification and delivery of the test result.

4.3. Supervision and actions to be taken after receipt of the test result

After obtaining the test result, the PCR test prescribing facility should take actions conforming to the current national guidelines for HIV/AIDS diagnosis and treatment of the Ministry of Health.

5. Completing forms and administering data

- The facility shall perform the test for the early diagnosis of HIV infection in infants and children under 18 months of age after obtaining the test result available on the test diagram/the lab activity form and the reading sheet, and these test results must be entered into the test record book under regulations laid down in the appendix IV-C in these guidelines.  

- Test results should be filed in accordance with regulations in force, and use of the correction pen for correcting any error shall be prohibited. In case of any error that may arise, cross out the error, rewrite the correct words and give the competent person's signature adjacent thereto.

- The officer in charge of the test laboratory shall be responsible for checking all test information and test documents before signing the test results informed to the client.

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6. Test quality assurance

The test quality assurance shall be subject to Section 5 Part II Chapter I, and the following regulations:

6.1. Test kits and consumables specially designed for the molecular biology tests shall be allowed, including unpowdered gloves, filter vials and tubes without the destructive yeast nucleic acids.

6.2. Equipment must conform to technical requirements of each test facility and the test facility must ensure each test area has particular tools and equipment to avoid cross contamination.

6.3. Facilities

- If the test facility uses fully automatic and closed systems, they must be installed at locations required by manufacturers and such installation must help reduce the risks of cross contamination between different activities. 

- If the test facility uses unclosed systems, it shall be necessary to organize at least 3 completely separate zones accommodating the following activities: chemical preparation, sample preparation, PCR sample magnification and analysis.

6.4. Personnel

- They must be trained and must accumulate experience in performing the molecular biology test and HIV testing. 

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7. Laboratory biosafety

- The laboratory biosafety shall be subject to Section 6 Part II Chapter I, and other level-II biosafety regulations.

II. Early diagnosis of HIV infection in children older than 18 months and adults.

1. Persons advised to take the test:

a. Those who have already taken the HIV serological test with the indeterminate test results. 

b. Blood screening by employing the NAT technique must comply with the existing regulations on safe blood transfusion and screening of safe units of blood.      

2. Competence in performing the test

This shall be subject to Part I, Section 2, Part II  of these guidelines.

3. Test procedures

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- Fill out all required information in the “Test form for the qualitative PCR test for the diagnosis of HIV infection in children older than 18 months and adults" as provided in regulations laid down in the Form No. 4, Appendix IV-C hereto attached. 

- The sample used in the molecular biology test may be DBS, full blood sample or blood plasma sample.

- The procedures for blood sample collection, packing, transport and receipt of DBS shall be prescribed in the Appendix II hereto attached.

- The procedures for blood sample collection, packing, transportation and receipt of the full blood and plasma sample shall be subject to regulations laid down in the Appendix II hereto attached.

3.2. Implementation of the test and several concerns

- The test kit used in the test must have the valid circulation number or must be approved for use by the Ministry of Health, and must remain unexpired.

- The HIV PCR test must be performed according to the manufacturer’s instructions.

- Store the specimen inside the deep freezer at the maximum temperature of -70^oC as per regulations in force for the minimum duration of 2 years in case of the specimen testing positive.

- Labels attached to the specimen must be waterproof and freeze-resistant to avoid being spoiled at the freeze temperature.

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- With respect to the destruction of the specimens testing positive and those suspected of HIV infection, these specimens shall be destroyed upon expiration of the sample storage duration in accordance with regulations in force, and the report on destruction of specimens must be made and include the list of destroyed specimens.  This report must be deposited for a period of 5 years from the specimen destruction date.

3.3. Test result notification and delivery

3.3.1. Time of test result notification and delivery

- The PCR test result needs to be informed and delivered to the test prescribing facility within a period of 02 weeks from the date on which the test laboratory receives the sample.

- In case of failure to do so, the test laboratory should inform the test prescribing facility of the reasons and the deadline for notification and delivery of the test result.

3.3.2. Test result recording

- If the PCR test result is negative, write “Negative” in the section “Test result notification and delivery”. 

- If the PCR test result is positive, write “Positive” in the section “Test result notification and delivery”. 

3.3.3. Test result notification and delivery

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3.3.4. Supervision and actions to be taken after receipt of the test result

After obtaining the test result, the PCR test prescribing facility should provide the client with counseling under the current instructions for HIV test counseling at healthcare service providers of the Ministry of Health.

a. If the test result is positive

The medical staff member of the sample collection facility shall perform the following tasks after receipt of the positive PCR test result:

- Contact the test performing facility to request it to consider the second collection of the blood sample (where necessary).

- Inform the test result and provide counseling in accordance with laws. 

- Carry out the ongoing surveillance at the HIV/AIDS health facilities.

b. If the test result is negative

The medical staff member of the sample collection facility should perform the following tasks after receipt of the negative PCR test result:

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- Explain the test result:

+ Those who have been exposed to HIV for more than 02 weeks are not likely to be infected with HIV, need the ongoing surveillance and should take another test to find anti-HIV antibodies 3 months and 6 months after exposure.     

+ Those who have been exposed to HIV for less than 02 weeks remain likely to be infected with HIV, need to take the molecular biology test 02 weeks or take another test to find anti-HIV antibodies 3 months and 6 months after exposure.    

5. Completing forms and administering data

These activities shall be subject to regulations laid down in Section 5 Part I of this Chapter.

6. Test quality management and assurance

These activities shall be subject to regulations laid down in Section 6 Part I of this Chapter.

7. Biosafety activities

These activities shall be subject to regulations laid down in Section 7 Part I of this Chapter.

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HIV RETESTING

I. Periodical HIV testing in case of continued high-risk behaviors:

1. Persons with high risks of HIV infection who have already tested positive for HIV infection shall need to take the periodical HIV tests every 6 months, including:

- The population with high-risk behaviors

- Those whose partners are already infected with HIV

- Patients infected with sexually transmitted diseases

- People treated with post-exposure prophylaxis (PEP) and pre-exposure prophylaxis.

2. The HIV retest shall be performed in accordance with regulations laid down in Chapter II hereof.

* Note: Cases suspected of being in the window period should take a retest in the next 3 months.

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1. General principles:

- Do not recommend the HIV retest for patients who undergo the past and present ARV therapy.

2. Determining HIV infection status where necessary:

2.1. With respect to cases that have already taken the HIV viral load measurement test during the process of monitoring of the ARV therapy.

- If the test result is above the detectable level, the HIV infection status is confirmed.

- If the test result is below the detectable level, the HIV serological retest must be performed by using all 3 test kits according to the national testing algorithm at the test facility accredited to confirm the HIV positive result, including the specific regulations mentioned hereunder:

+ If the test result is positive according to the strategy III, the test result shall be informed and delivered in accordance with regulations in force.

+ If the test result is negative or indeterminate, re-sampling shall be required for another molecular biology test according to the test procedures referred to in 2.3 of this Section.

2.2. In case where the result of the HIV viral load measurement test has not been produced during the process of monitoring of the ARV therapy, the test procedures referred to in 2.3 must be followed.

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HIV RETEST PROCEDURES

Note:

(*) Cease the therapy only when the DNA test result is obtained

(**) Only take the HIV serological test once in the next 3 months following cessation of the therapy:

- If the test result is positive, HIV infection is confirmed and the therapy is recommenced.

- If the test result is negative or indeterminate, the HIV viral load measurement test is required:

+ If the test result is above the detectable level, HIV infection is confirmed and the therapy is recommenced.

+ If no genetic material is detected, the HIV-negative conclusion is drawn. 

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1. The HIV retest should be taken 3-6 months after the therapy.

2. This HIV retest shall be performed in accordance with regulations laid down in Chapter II hereof.

Part III

IMPLEMENTATION ORGANIZATION

1. Responsibilities of HIV screening test providers or laboratories

1.1. Collect or receive specimens used in HIV infection test techniques, except the confirmation of HIV positive cases.

1.2. Participate in the program for external control or assessment of HIV tests, approved or designated by the Ministry of Health.

1.3. Provide counseling for HIV test and inform HIV test results in accordance with the Law on HIV/AIDS prevention and control.

1.4. Make the data statistical report under the provisions of the Circular No. 09/2013/TT-BYT, and create and deposit all required test forms and books in accordance with regulations laid down herein.

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Notwithstanding provisions set forth in Section 1 of this Part, they shall assume the following responsibilities:

1.1. Perform HIV diagnostic tests for directly collected specimens. 

1.2. Receive suspected HIV positive specimens from HIV screening test providers or laboratories within their locality or adjacent areas in order to perform the HIV serological confirmatory test for HIV-positive cases. Store known or suspected HIV positive samples for a period of 02 years from the date of the confirmatory test performed at these test providers or laboratories.

1.3. Counsel or assist the affiliated Department of Health in technical assistance training and surveillance, and participate in the periodical inspection of testing activities carried out HIV screening test providers or laboratories within the locality under their control once a year.

3. Responsibilities of the national HIV reference laboratory

3.1. Perform HIV serology and molecular biology tests. 

3.2. Receive suspected HIV positive samples and those with results difficult to interpret from test providers or laboratories obtaining the certificate of compliance with regulations on HIV confirmatory tests for HIV positive cases within its ambit. 

3.3. Receive samples and perform reference tests in the event that there is any discrepancy between HIV test results produced by test providers or laboratories.  

3.4. Carry out and administer the test quality control for HIV test providers and laboratories.

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4. Responsibilities of the Departments of Health of provinces:

4.1. Direct and inspect HIV testing activities carried out within their ambit.

4.2. Assign HIV/AIDS control centers/bodies assigned HIV/AIDS control roles and duties that own HIV confirmatory test facilities, or collaborate with bodies having HIV confirmatory test facilities, to develop training plans and organize training for grant of certificates to HIV testing officers of HIV screening test providers and laboratories within cities/provinces.

4.3. Recommend any amendment or supplementation in order to deal with unsolved issues relating to HIV test quality control and assurance.

4.4. Collaborate with related regulatory departments or divisions, and organize the surveillance of implementation of HIV tests.

4.5. Prepare an annual report to the Ministry of Health on the list of test providers and laboratories performing HIV confirmatory tests and HIV screening tests within their ambit.

5. Responsibilities of the National Institute of Hygiene and Epidemiology, Pasteur Institute of Ho Chi Minh city, Pasteur Institute of Nha Trang city and the Institute of Hygiene and Epidemiology of Central Highlands

5.1. Train and provide technical assistance for officers of HIV confirmatory providers and laboratories, and HIV screening test providers and laboratories at provinces where there is none of HIV confirmatory test providers and laboratories within localities under their jurisdiction.

5.2. Carry out the inspection and supervision of HIV confirmatory test providers and laboratories within localities under their jurisdiction once a year and send a review report on results of such inspection and supervision to the Ministry of Health (Vietnam Administration for HIV/AIDS Control).

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6.1. Direct, inspect, supervise and assess test services and aggregate data of HIV testing activities nationwide.

6.2. Direct facilities with national reference laboratories to design HIV testing materials and organize HIV testing training for affiliates and local bodies.

6.3. On an annual basis, preside over and cooperate in organization of seminars intended for assessment and implementation of HIV test quality control and assurance.