SARS-CoV-2 Antigen Rapid Diagnostic Test –

Competency Assessment

Intended use

This tool is intended to be used by the trainer to assess the success of the training and the resulting
competency of laboratory or health care workers in conducting SARS-CoV-2 Antigen RDT testing. The
objective of the competency assessment is to determine whether participants have understood the content of
the training, can safely and accurately perform the nasopharyngeal sample collection and SARS-CoV-2
Antigen RDT(s), and can interpret and record the test result(s).

This competency assessment will be carried out after initial training. Once testers have collected two
nasopharyngeal samples and processed a minimum of two SARS-CoV-2 Antigen RDTs during the training,
each tester will be asked to independently perform two complete SARS-CoV-2 Antigen RDT tests in parallel
using blinded samples (if possible). Testers will be able to use job aids. The moderator will observe without
intervening or correcting mistakes.

To obtain a Certificate of Successful Completion, testers will be required to:

1. obtain a passing score of 80% on the practical test (Section A), in which testers will be required to
collect one nasopharyngeal sample while being observed by a trainer;
2. obtain a passing score of 80% on the practical test (Section B), in which testers will be required to
perform two SARS-CoV-2 Antigen RDTs on blinded samples while being observed by a trainer;
3. obtain a passing score of 80% on the written theoretical test (Section C), in which testers will be
required to answer fifteen multiple-choice questions on content presented in the workshop;
4. obtain a passing score of 80% on the practical result reading test (Section D), in which testers will be
required to correctly interpret different SARS-CoV-2 Antigen RDT results from photographs
provided.

Materials needed to conduct competency assessments

See the Checklist of Training Materials. Training materials include:
 new (unopened) sterile swabs for each participant to perform three sample collections
 personal protective equipment (PPE), including gloves, gowns, eye protection or face-shields and medical
masks
 pens for marking or labelling
 household bleach, ethanol and paper towels to clean the workstation and hands
 soap for hand-washing
 sufficient SARS-CoV-2 Antigen RDT kits for each participant to perform three (practice) tests and two
competency (proficiency) tests
 leak-proof biohazard bags for containing or moving biohazard waste and waste bins
 three spray bottles (two for bleach working solutions of 0.1% and 1%, one for ethanol)
 measuring devices for making bleach and alcohol solutions
 timers
 proficiency test materials (positive and negative controls)1
 SARS-CoV-2 Antigen RDT Logbook
 thermometer

1
See Module 10: Assuring quality results for instructions on how to prepare the quality control material. If no
positive and negative controls are available, collect nasopharyngeal swabs for demonstrating the SARS-
CoV-2 Antigen RDT testing and conducting the competency assessments.

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SARS-CoV-2 Antigen Rapid Diagnostic Test –
Competency Assessment

A. Practical Test: Nasopharyngeal sample collection

Instructions:
 Don PPE.
 Prepare the workspace.
 Collect one nasopharyngeal sample2.
 The tester has to perform the tasks outlined in the checklist correctly. If not, the answer should be
“NO” and an explanation should be provided in the last column.
 For each correctly performed item, the tester will obtain 1 point.

Tester’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

Number Question Yes No Comment

1 Did the tester put on the appropriate PPE for
testing?
2 Did the tester collect all the necessary supplies
to perform nasopharyngeal sample collection?
3 Did the tester insert a sterile swab into the
nostril of the patient, reaching the surface of
the posterior nasopharynx?
4 Did the tester swab over the surface of the
posterior nasopharynx?
5 Did the tester withdraw the sterile swab from
the nasal cavity?
SECTION A: Score / Number of correct answers /5= % …………… %

Moderator’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

SARS-CoV-2 Antigen Rapid Diagnostic Test –

2
Nasopharyngeal swabs are the often preferred sample for testing using SARS-CoV-2 Antigen RDTs. As
new tests become available, other sample types are being used, such as nasal swabs. Always refer to the
kit's IFU which will specify the type of samples to use.

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Competency Assessment

B. Practical Test: SARS-CoV-2 Antigen RDT3

Instructions:
 Don PPE.
 Prepare the workspace.
 Process two samples in parallel according to the SARS-CoV-2 Antigen RDT Quick Reference
Guide/Instructions for Use.
 Doff PPE.
 The tester has to perform the tasks outlined in the checklist for BOTH samples correctly. If not, the
answer should be “NO” and an explanation should be provided in the last column.
 For each correctly performed item, the tester will obtain 1 point.

Tester’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

Number Question Yes No Comment

1 Did the tester put on the appropriate PPE for (See Section A:1)
testing?
2 Did the tester carefully read the instructions
for using the SARS-CoV-2 Antigen RDT?
3 Did the tester collect all the necessary supplies
to perform the SARS-CoV-2 Antigen RDT
procedure?
4 Did the tester set up the workstation correctly?
5 Did the tester check the expiry date of the
SARS-CoV-2 Antigen RDT?
6 Did the tester check that the test device and
the desiccant pack in the foil pouch were not
damaged or invalid?
7 Did the tester insert the swab into an
extraction buffer tube and, while squeezing
the buffer tube, stir the swab?
8 Did the tester remove the swab while
squeezing the sides of the tube to extract the
liquid from the swab?
9 Did the tester press the nozzle cap tightly onto
the tube?
10 Did the tester apply the required number of
drops of extracted specimen to the specimen
well of the test device?
11 Did the tester read the SARS-CoV-2 Antigen
RDT result after the required amount of time?
12 Did the tester interpret the SARS-CoV-2
Antigen RDT result correctly?
13 Did the tester record the test result in the
SARS-CoV-2 Antigen RDT Logbook?
14 Did the tester dispose of all waste (e.g., used
test kit, extraction buffer tube, swab and paper
stand) in the biohazard bag?
15 Did the tester remove their gown and gloves
before leaving the workstation?
16 Did the tester practice proper hand hygiene
after completing the SARS-CoV-2 Antigen
RDT procedure?

3
This procedure must be adapted to the specificities of the SARS-CoV-2 Antigen RDT being performed.

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 Number Question Yes No Comment
SECTION B: Score / Number of correct answers / 16 = % …………… %

Moderator’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

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SARS-CoV-2 Antigen Rapid Diagnostic Test –
Competency Assessment
C. Theoretical Test

Instructions:
 The moderator will provide the tester with this sheet.
 The tester will be required to answer fifteen multiple-choice questions on the content presented in
the workshop.
 The tester will obtain 1 point when the whole question is answered correctly.

Tester’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

SARS-CoV-2 Antigen RDT Questions Answered If NO, add comment

correctly
YES NO
1. What does an antigen RDT detect?
 Viral antigens
 Viral RNA
 Viral DNA
 None of the above

2. One disadvantage of testing for SARS-CoV-2

infections with antigen RDTs is that
❑ Tests can be performed outside a laboratory (e.g., clinical
facility)
❑ Results are rapidly available
❑ Antigen RDTs are less sensitive than NAAT (Nucleic Acid
Amplification Test)
❑ Antigen RDTs are simple to perform

YES NO
3.In which of the following scenarios does WHO
currently recommend using SARS-CoV-2 antigen
RDTs?
❑ When testing individuals without symptoms (unless the
person is a contact of a confirmed case)
❑ When testing individuals with symptoms in areas where
SARS-CoV-2 transmission is very high
❑ Where appropriate biosafety and infection prevention and
control measures are lacking
❑ For airport or border screening at points of entry

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 YES NO
4. Select one practice from the list below that could lead
to testing errors.
❑ Testing according to the manufacturer’s Instructions for Use
(IFU)
❑ Testing several days after specimen collection
❑ Using test kits that have not expired
❑ Systematically cross-checking the labels of the sample
request form and the sample container

YES NO
5. Which one of the following practices might increase
the risk of disease transmission when performing
SARS-CoV-2 testing with antigen RDTs?
❑ Ensuring good ventilation
❑ Using Personal Protective Equipment (PPE)
❑ Having inappropriate waste management
❑ Following procedures and good practices

YES NO
6. Which PPE should personnel be wearing when
performing SARS-COV-2 antigen RDTs? (select all
that apply)
❑ Gloves
❑ Long-sleeved gown
❑ Coveralls
❑ Eye and respiratory protection

YES NO
7. Which of the following should be performed when
managing supplies? (select all that apply)
❑ Performing regular stock counts (e.g., weekly)
❑ Identifying personnel in charge of stock counts and record
management
❑ Checking the integrity of supplies when they are delivered
to the facility
❑ Allowing kits to expire before ordering more

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 YES NO
8. Select one correct statement from the list below
❑ A SARS-CoV-2 antigen RDT that is negative can be re-
used for another test/patient
❑ If the pouch or seal of the test is damaged, that test should
not be used
❑ It is fine to use the extraction buffer tube from another kit if
a tube is missing
❑ Test results can be read several hours after the specified
period of time

YES NO
9.Which of the following are components of quality
assurance?
Quality control testing
Supervisory visits
Proficiency testing
All of the above

YES NO
10. Among the following statements, which one is
incorrect?
❑ Record keeping allows the testing site to monitor the quality
of testing using quality indicators (QIs)
❑ Records such as test requisition forms, results logbooks
and temperature logs should be kept onsite
❑ All records can be accessed by anyone as they do not
contain confidential information
❑ When QIs fall outside of an acceptable range, the cause
should be identified, and corrective actions taken

11. How would you interpret this SARS-CoV-2 antigen

RDT result, based on the photograph?

❑ Positive
❑ Negative
❑ Invalid

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 12. How would you interpret this SARS-CoV-2 antigen
RDT result, based on the photograph?

❑ Positive
❑ Negative
❑ Invalid

13. How would you interpret this SARS-CoV-2 antigen

RDT result, based on the photograph?

❑ Positive
❑ Negative
❑ Invalid

14. How would you interpret this SARS-CoV-2 antigen

RDT result, based on the photograph?

❑ Positive
❑ Negative
❑ Invalid

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 15. You run a SARS-CoV-2 antigen RDT on a sample from
a patient with respiratory symptoms. According to the
instructions for use of the test kit, the maximum
reading time is 15 min. You were distracted by your
boss who came to ask you a question and you only
read the result at 20 min. What would be your action if
when reading the RDT result you see a faint line in
front of ‘T’ (test line) and a line in front of ‘C’
(control)?

❑ Record the test as positive

❑ Record the test as negative
❑ Repeat testing
❑ None of the above

SECTION C: Score / Number of correct answers / 15 …………… %

Moderator’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

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SARS-CoV-2 Antigen Rapid Diagnostic Test –
Competency Assessment

D. Practical Result Reading Test

Instructions:
 The tester has to select the option (positive, negative, invalid) for each of the result examples.
 The tester must describe the patient management based on the result.
 For each correct item, the tester will obtain 1 point.

Tester’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

Test result
Result interpretation Comment
example

1. Positive Negative Invalid

2. Positive Negative Invalid

3. Positive Negative Invalid

4. Positive Negative Invalid

5. Positive Negative Invalid

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 Test result
Result interpretation Comment
example

6. Positive Negative Invalid

7. Positive Negative Invalid

8. Positive Negative Invalid

9. Positive Negative Invalid

10. Positive Negative Invalid

SECTION D: Score / Number of correct / 10 …………… %

answers

Moderator’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

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SARS-CoV-2 Antigen Rapid Diagnostic Test –
Competency Assessment

E. Conclusion

Tester’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

If NO, add comment

Performance targets met?

Score Part A: ≥80%? YES NO

Score Part B: ≥80%? YES NO
Score Part C: ≥80%? YES NO
Score Part D: ≥80%? YES NO
Conclusion: Tester passed competency
YES# NO
assessment
#
Tester can only pass the competency test if the scores for individual Parts A, B, C and D are ALL met.

Moderator’s name: _____________________ Date (dd/mm/yy): __ __/__ __/__ __

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Theoretical test answers

SARS-CoV-2 Antigen RDT Questions

1. What does an antigen RDT detect?

◼︎Viral antigens
 Viral RNA
 Viral DNA
 None of the above

2. One disadvantage of testing for SARS-CoV-2 infections with antigen RDTs is that
❑ Tests can be performed outside a laboratory (e.g., clinical facility)
❑ Results are rapidly available
◼︎Antigen RDTs are less sensitive than NAAT (Nucleic Acid Amplification Test)
❑ Antigen RDTs are simple to perform

3. In which of the following scenarios does WHO currently recommend using SARS-CoV-2
antigen RDTs?
❑ When testing individuals without symptoms (unless the person is a contact of a confirmed case)
◼︎When testing individuals with symptoms in areas where SARS-CoV-2 transmission is very high
❑ Where appropriate biosafety and infection prevention and control measures are lacking
❑ For airport or border screening at points of entry

4. Select one practice from the list below that could lead to testing errors.
❑ Testing according to the manufacturer’s Instructions for Use (IFU)
◼︎Testing several days after specimen collection
❑ Using test kits that have not expired
❑ Systematically cross-checking the labels of the sample request form and the sample container

5. Which one of the following practices might increase the risk of disease transmission when
performing SARS-CoV-2 testing with antigen RDTs?
❑ Ensuring good ventilation
❑ Using Personal Protective Equipment (PPE)
◼︎Having inappropriate waste management
❑ Following procedures and good practices

6. Which PPE should personnel be wearing when performing SARS-COV-2 antigen RDTs? (select
all that apply)
◼︎Gloves
◼︎Long-sleeved gown
❑ Coveralls
◼︎Eye and respiratory protection

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 7. Which of the following should be performed when managing supplies? (select all that apply)
◼︎Performing regular stock counts (e.g., weekly)
◼︎Identifying personnel in charge of stock counts and record management
◼︎Checking the integrity of supplies when they are delivered to the facility
❑ Allowing kits to expire before ordering more

8. Select one correct statement from the list below

❑ A SARS-CoV-2 antigen RDT that is negative can be re-used for another test/patient
◼︎If the pouch or seal of the test is damaged, that test should not be used
❑ It is fine to use the extraction buffer tube from another kit if a tube is missing
❑ Test results can be read several hours after the specified period of time

9. Which of the following are components of quality assurance?

Quality control testing
Supervisory visits
Proficiency testing
◼︎All of the above

10. Among the following statements, which one is incorrect?

❑ Record keeping allows the testing site to monitor the quality of testing using quality indicators (QIs)
❑ Records such as test requisition forms, results logbooks and temperature logs should be kept onsite
◼︎All records can be accessed by anyone as they do not contain confidential information
❑ When QIs fall outside of an acceptable range, the cause should be identified, and corrective actions
taken

11. How would you interpret this SARS-CoV-2 antigen RDT result, based on the photograph?

◼︎Positive
❑ Negative
❑ Invalid

12. How would you interpret this SARS-CoV-2 antigen RDT result, based on the photograph?

❑ Positive
◼︎Negative
❑ Invalid

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 13. How would you interpret this SARS-CoV-2 antigen RDT result, based on the photograph?

❑ Positive
❑ Negative
◼︎Invalid

14. How would you interpret this SARS-CoV-2 antigen RDT result, based on the photograph?

❑ Positive
◼︎Negative
❑ Invalid

15. You run a SARS-CoV-2 antigen RDT on a sample from a patient with respiratory symptoms.
According to the instructions for use of the test kit, the maximum reading time is 15 min. You
were distracted by your boss who came to ask you a question and you only read the result at
20 min. What would be your action if when reading the RDT result you see a faint line in front
of ‘T’ (test line) and a line in front of ‘C’ (control)?

❑ Record the test as positive

❑ Record the test as negative
◼︎Repeat testing
❑ None of the above

Reading sheet answers

1. Positive
2. Negative
3. Invalid
4. Negative
5. Positive
6. Negative
7. Invalid

SARS-CoV-2 Antigen Rapid Diagnostic Test Training Workshop – v2.0 Page 15 of 16

 8. Positive
9. Positive
10. Negative

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