Evidence Summary For Rapid Antigen Test As of 27 Sep 2021

Evidence Summary on the Use of Rapid
Antigen Test Kits for the Diagnosis of

COVID-19
Service Line Evidence Summary
Publication Date 27 September 2021
Adopted Report Rapid Review on the Use of Rapid Antigen Test Kits for
the Diagnosis of COVID-19 (published on 24 September
2020)
Summary Length 33 Pages
Prepared by Health Technology Assessment Council

Health Technology Assessment Unit
Contact details [email protected] | 8-875-7734 loc. 260 or 258

Evidence Summary |2
Acronyms Used in the Evidence Summary
Acronym Definition
Australia PHLN Australia Public Health Laboratory Network
Australia TGA Australian Therapeutic Goods Administration
Ct Cycle threshold
DOH Department of Health (Philippines)
ECDC European Center for Disease Prevention and Control
FIND Foundation for Innovative New Diagnostics
Japan MHLW Ministry of Health, Labor, and Welfare of Japan
NPS Nasopharyngeal Swab
OPS Oropharyngeal Swab
PHAC Public Health Agency of Canada
PhilHealth Philippine Health Insurance Corporation
RITM Research Institute for Tropical Medicine
SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2
UK MHRA United Kingdom Medicines and Health Products Regulatory Agency
US CDC United States of America Center for Disease Control and Prevention
US FDA United States of America Food and Drug Administration
WHO World Health Organization
hta.doh.gov.ph Use of Rapid Antigen Test Kits for COVID-19 (as of 27 September 2021)
Evidence Summary |3
Table of Contents
Page Number
Acronyms Used in the Evidence Summary 2
I. Background 4
II. Policy Question 5
III. Research Questions 5
IV. Evidence Considered 5
A. Responsiveness to Disease Magnitude, Severity, and Equity 5
B. Safety and Effectiveness 6
1. Regulatory Standards 6
2. Guideline Recommendations 6
3. Diagnostic Performance 14
a. Evidence from Local Diagnostic/Evaluation Studies 14
b. Evidence from International Diagnostic Studies 14
C. Household Financial Impact 15
D. Cost-effectiveness 15
E. Affordability and Viability 16
V. Recommendations (as of 30 April 2021) 16
VI. References 23
VII. Annexes 29
Evidence Summary |4
I. Background
The World Health Organization (WHO) declared the novel coronavirus disease (COVID-19),
caused by severe acute coronavirus 2 (SARS-COV-2), a global pandemic affecting hundreds of
countries and millions of people around the world.
In response to this public health emergency, the Philippine Department of Health (DOH) issued
testing guideline policies which currently sets the real time reverse transcriptase polymerase
chain reaction (RT-PCR) as the standard confirmatory test to diagnose COVID-19. Due to the
nationwide limited capacity to perform laboratory-based tests and the proliferation of other
COVID-19 diagnostic technologies in the market, the use of point-of-care tests have been
explored and the Health Technology Assessment Council (HTAC) has already evaluated rapid
antigen tests last October 2020. In its interim recommendation, the HTAC has approved the use
of rapid antigen tests only for these very specific purposes:
● For targeted screening and diagnosis of suspect and probable cases of COVID-19
meeting the clinical and/or epidemiologic criteria as currently defined by the WHO
(i.e., with high index of suspicion) in the hospital or community settings (e.g., for
testing of first-degree contacts);
● For testing of patients in the hospital setting, where the turnaround time is critical, to
guide patient cohort management in order to minimize transmission of COVID 19
among healthcare workers and other patients. (Hospitals are high-risk settings
among healthcare workers and patients.) Otherwise, use RT-PCR in case of elective
procedures.
Further, the HTAC has set at least 80% and 97% specifications for clinical sensitivity and
clinical specificity, respectively, along with other technical requirements such as turnaround
time, reference standard, among others.
This evaluation has led to the integration of rapid antigen test kits in the Omnibus Interim
Guidelines on Prevention, Detection, Isolation, Treatment, and Reintegration Strategies for
COVID-19 (DM 2020-0439).
This evidence summary was developed to update evidence on regulatory data on gene targets,
country guidelines on use of RAgT as well as repeated testing, as well as the diagnostic
performance of these tests for COVID-19 detection.
Evidence Summary |5
II. Policy Question
Should the Philippine Department of Health consider the use of rapid antigen test kits
(RAgTs) for the diagnosis of COVID-19?
III. Research Questions
1. Regulatory Approval
1.1. What are the gene targets recommended by regulatory agencies for the antigen
test kits?
2. Performance Characteristics
2.1. What is the value (diagnostic performance) of repeated antigen testing
compared to confirmatory RT-PCR and to symptom-based screening?
2.2. What is the value (diagnostic performance) of rapid antigen tests in screening
and diagnosing COVID-19?
3. Global guidelines and position on use of RAgTs

3.1. What are the current use cases of rapid antigen tests (COVID-19 diagnosis)
based on country guidelines?
3.2. What is the role (use case) of repeat antigen testing vs. RT-PCR?
3.3. For repeat testing or serial testing, what are the recommended
duration/intervals?
IV. Evidence Considered
A. Responsiveness to Disease Magnitude, Severity, and

Equity
The World Health Organization (WHO) declared the novel coronavirus disease
(COVID-19), caused by severe acute coronavirus 2 (SARS-COV-2), a global pandemic.
The most common symptoms are fever, sore throat, malaise and dry cough. The
symptoms are usually mild and begin gradually. It can spread from person-to-person
through small droplets when coughing or sneezing. As of 23 March 2021, it has
affected more than 192 countries and regions with at least 123,623,396 cases and
2,722,167 deaths worldwide (Johns Hopkins CoronaVirus Resource Center, 2021). In
the Philippines, COVID-19 affected over 671,792 cases with 12,972 deaths as of 22
March 2021 (DOH, 2021).
Evidence Summary |6
B. Safety and Effectiveness
1. Regulatory Standards
Of the 11 regulatory agencies reviewed for any regulatory guidelines for recommended
gene targets of COVID-19 RAgTs, no agency has explicitly provided a recommendation on
the preferred gene target for rapid antigen tests, to date. However, the UK Medicines and
Healthcare Products Regulatory Agency (MHRA) briefly mentioned in their target product
profile that the desired target analyte be two or more RNA or antigen targets. Likewise,
Paul-Ehrlich-Institut in Germany mentions that manufacturers must specify the antigens
that will be identified by the test. Furthermore, they mention that evidence must be provided
that mutations of SARS-CoV-2, which lead to a variation in the spike antigen (e.g. the “UK
variant”) are still reliably detected when the target antigen being detected by the test is the
surface (spike) protein.
2. Guideline Recommendations
Thirteen countries (US, Japan, South Korea, Vietnam, United Kingdom (UK), Australia,
Malaysia, China, Philippines, Canada, Singapore, Indonesia and Thailand) as well as the
European Union (EU) and the WHO were checked regarding their current recommendations
on antigen testing. Of these:
● Recommended use cases for antigen testing Nine countries (US, Philippines, Vietnam,
Canada, Japan, UK, Australia, and Malaysia) as well as the EU and WHO recommend the
use of antigen testing for COVID-19.
o Currently, the US, Philippines, Canada, Japan, Malaysia, Vietnam, EU, and WHO
recommends the use of RAgTs in the diagnosis of COVID-19. In particular, the
Philippines, US, EU, and Canada recommend its use among symptomatic patients
particularly those with high pretest probability. The Philippine DOH also allows the use
of antigen testing for the diagnosis of close contacts in communities and closed or
semi-closed institutions with confirmed outbreaks and in remote settings where
RT-PCR is not immediately available. The EU also recommends the use of the test for
contacts of confirmed cases and outbreak clusters. On the other hand, Japan
mentions that this test can be used for patients suspected of COVID-19, while
Vietnam notes that these tests must reach the standards set by WHO or US CDC
before being used as a confirmatory test. In Malaysia, antigen testing is considered as
a confirmatory test but only in certain circumstances where there are confirmed
COVID-19 clusters or outbreaks or areas identified by Malaysian Ministry of Health.
The WHO also recommends the use of antigen tests as a diagnostic test in a range of
settings such as in responding to suspected outbreaks of COVID-19 in remote
settings, institutions and semi-closed communities where nucleic acid amplification
test (NAAT) is not immediately available, in monitoring trends in disease incidence in
Evidence Summary |7
communities, in areas with widespread community transmission, and in testing

asymptomatic contacts of cases.
o As a diagnostic test, Japan MHLW, US CDC, Philippines, and WHO consider a positive
antigen test to be reliable given the high specificity of approved tests; while a negative
test must be considered presumptive and a confirmatory test must be conducted
when applicable. The US CDC, Philippines, and the WHO guidelines highlighted that
confirmatory testing following a negative antigen test should be done subject to the
use case, pretest probability, and clinical context of the patient while the guidelines
released by MHLW in Japan states that the physician will decide on the need to
conduct PCR test for a negative antigen test. In general, the decision on conducting
confirmatory testing for a negative antigen result should be based on the clinical
characteristics and history of the patient.
o In terms of screening, the Philippines, US, EU, Singapore, Malaysia, and WHO
recommend the use of RAgT for screening purposes in specific settings.
▪ The US, EU, and the Philippines recommend its use for testing in high-risk
congregate settings while Singapore allows the use of the test in pre-event
testing. In addition, the EU recommends the use of the test for this use case at
the population-wide level in epidemiological situations or areas where
proportion of test positivity is high or very high. In any case, the EU includes in
their recommendation the need for strategies to be put in place to clarify when
confirmatory testing by RT-PCR or a second rapid-antigen test is needed. In
Malaysia, antigen tests are used as screening tests in the following scenarios:
emergency and semi-emergency procedures or surgical cases with high
probability of COVID-19 infection, brought in dead (BID) in low probability
cases when indicated, symptomatic person in a confirmed cluster/outbreak
management, for close contact in a confirmed cluster/outbreak management,
screening for Acute Respiratory Infection (ARI), and other screening identified
by the Malaysian Ministry of Health. Lastly, the WHO mentions that RAgT can
be used to screen at-risk individuals in confirmed COVID-19 outbreaks and
rapidly isolate positive cases and prioritize sample collection from
RDT-negative individuals for NAAT.
▪ In terms of result interpretation, the US guidelines for the screening of
populations with high pre-test probability using RAgT follow the same
recommendation as that for the diagnostic testing among populations with
high pre-test probability using RAgT. However, for the screening of patients
with low pretest probability, the US guidelines require patients with positive
antigen test to isolate until confirmed by RT-PCR, while a negative antigen test
can be considered negative and may not anymore require an RT-PCR
confirmatory test. In Malaysia, a positive antigen test result is regarded as
probable COVID-19 and shall be followed by RT-PCR to confirm as COVID-19
case, similar to the guidelines for use in Singapore.
Evidence Summary |8
▪ A separate section is presented for the review of guidelines mentioning the

use of antigen testing for border control policies.
o In the UK, no specific use case was mentioned for the use of antigen tests. However,
they note that a positive antigen result interpretation depends on where the antigen
test is conducted. If conducted at a testing site, a PCR test may be asked to confirm
the result; otherwise, if conducted at home, a PCR test is necessary to confirm the
result. A negative antigen result suggests the test did not find signs of coronavirus.
On the other hand, Australia did not have guidelines on the use of antigen tests but its
Public Health Laboratory Network (PHLN) noted that these are currently being
evaluated to determine clinical utility in various settings.
● Use cases where antigen testing is not recommended According to the WHO guidelines,
there are instances in which RAgTs are not recommended for use:
o settings or populations with low prevalence of disease;
o in individual without symptoms, unless that person is a contact of a confirmed
case;
o in areas where there are zero or only sporadic cases;
o in areas where appropriate biosafety and infection prevention and control
measures are lacking;
o in situations in which the management of patient does not change based on the
result of the test;
o in airport or border screening at points of entry; and,
o in screening prior to blood donation.
● South Korea, and China do not mention the use of antigen testing in their current national
testing guidelines and recommend the use of RT-PCR as the standard test in diagnosing
COVID-19. Indonesia and Thailand do not have publicly accessible national testing
guidelines.
Repeated antigen testing Of the guidelines reviewed for use of rapid antigen tests, we note the
following countries that mention the use of repeated antigen testing:
● The US CDC and Public Health Agency of Canada (PHAC) suggests the use of repeated
rapid antigen tests in congregate settings where highly sensitive tests are not feasible, or if
turnaround times are prolonged. They note that negative results be considered as
presumptive negative and that health care providers should consider them in the context
of clinical observations, patient history, and epidemiological information. There was no
information on the timing of repeated testing for both agencies. Only the US CDC
mentioned regarding the recommended interval for repeat testing but only for institutions
of higher education (IHEs). They recommended that screening should be done on all
Evidence Summary |9
students, including those who live off campus, and should also consider implementing
entry screening testing for faculty and staff. In the context of low community transmission,
entry screening alone prior to the beginning of each term may be sufficient. In the context
of moderate community transmission, the US CDC recommends IHEs to implement both
universal entry screening and expanded serial screening testing at least weekly if sufficient
testing capacity is available. Lastly, in the context of substantial or high community
transmission, the US CDC recommends universal entry screening and expanded serial
screening testing at least twice weekly if sufficient testing capacity is available.
● In settings where there is widespread community transmission (e.g. health facilities, care
homes, prisons, schools) and in COVID-19 testing centres sites, contact tracing, or for
front-line and healthcare workers, the WHO cautions that a negative antigen test cannot
completely exclude active COVID-19 infection; hence, suggests repeat testing using
antigen test or preferably confirmatory testing by nucleic-acid amplification tests be
performed when possible especially among symptomatic patients. This is similar to the
guidance of the EU Commission stating that strategies must be put in place to clarify
when a second antigen test or confirmatory testing via RT-PCR is required. The WHO,
however, does not mention a recommended interval for conducting repeat testing given a
negative initial result but the European CDC advises that the test be repeated two to four
days later for screening asymptomatic patients in high prevalence areas and testing
symptomatics, excluding symptomatic patients in hospitals, long-term care facilities, or
other social care settings. In addition, EU CDC also mentions that RAgTs can be used for
screening and serial testing every two to three days for residents and staff of healthcare,
home care, long-term care facilities, closed setting and occupational settings with
community transmission. In the latest omnibus testing guidelines of the Philippines (DM
2020-0512) only RT-PCR test is mentioned for the recommended confirmatory test for
those with negative antigen results. It is noted, however, that in the previous omnibus
testing guidelines (DM 2020-0468), both confirmatory RT-PCR test and repeat antigen test
are recommended for negative antigen results.
● The UK, Japan, South Korea, Singapore, Indonesia, Vietnam, Australia, Malaysia, and China
did not mention repeated antigen testing in its current guidelines.
Use of Antigen testing for Border Control Of the guidelines reviewed for use of rapid antigen
tests, we note the following countries that mention the use of rapid antigen testing for border
control:
● Six countries (US CDC, Malaysia, UK, Japan, Indonesia, Germany) recommend the use of
antigen tests for border control. Of these, three countries (US, Malaysia, UK) recommend
its use for local and international border control; two countries (Japan and Germany) for
international control only; and, one country for local border control only (Indonesia).
Details are presented in Table 1.
● Meanwhile, one country guideline (Philippines) was noted to have an unclear
recommendation on its use for border control. In the current testing guidelines, it mentions
that RAgT is included as part of the additional measures and requirements for
Evidence Summary | 10
asymptomatic interzonal domestic travelers (with no established exposure/contact to a

probable or confirmed case). However, this is not explicitly stated as one of the
recommended use cases for antigen testing.
● The recommendations of the US CDC is similar to that of the findings from the modelling
study of Wells et al. (2021) which mentions that the optimal testing time is at day five or
six for quarantine durations of up to 7 days. Furthermore, the study mentions that testing
upon entry to quarantine carries risk of false negatives as the virus may not be
immediately detected among individuals due to low viral loads at the early stage of
disease. This is aligned with the recommendations of the US, Malaysia, UK, Japan, and
Germany which still requires antigen testing beyond entry to quarantine.
● Three countries (South Korea, Canada, ECDC) do not recommend the use of rapid antigen
testing for border control. The ECDC noted that RAgTs are not ideal for low-prevalence
populations such as screening incoming travellers. Further, they note that a positive RAgT
for low-prevalence populations should still be confirmed with an RT-PCR test. This is also
similar to the WHO guidelines which state that rapid antigen tests should not be used in
healthy traveller populations with low expected prevalence of disease.
● Five countries (China, Thailand, Australia, Vietnam, Singapore) did not mention the use of
rapid antigen tests for border control in their guidance documents. All inbound travellers to
Singapore are required to undergo RT-PCR, and those with previous infection are also
required to undergo serology testing for surveillance. Australia requires RT-PCR tests done
at most 72 hours prior to entering the country. On the other hand, Vietnam requires a
negative RT-PCR test three to seven days prior arrival. Similarly, travellers to Thailand are
required to present a negative PCR test issued no more than 72 hours before departure.
Table 1. Summary of Border control policies mentioning the use of Antigen Testing
Country Recommendation on Recommendation on Timing of Test Post Arrival Measures
antigen testing for antigen testing for local
international border border control
control
US CDC Nucleic acid amplification test or antigen

testing 3-5 days after arrival, combined
Within 3 days prior to departure with self-monitoring, and a 7-day home
quarantine. If not tested, a 10 day
Fully vaccinated domestic travelers do quarantine is required.
Recommended the use of antigen tests including
not need to get tested before travel
RAgTs
unless their destination requires it. Fully vaccinated domestic travelers do not
Vaccinated people are also required to need to get tested after travel unless their
be asymptomatic in some states. destination requires it. Self monitoring for
symptoms, isolation, and testing if
symptoms develop are still recommended.
UK Recommended the use of antigen tests such as

lateral flow devices from test providers for 10 full days of quarantine with repeat
pre-departure testing as long as they oblige the Within 72 hours prior to departure testing done on Day 2 and at least Day 8 of
requirement of ≥97% specificity and ≥80% sensitivity quarantine
at viral loads above 100,000 copies/ml.
Japan Recommends
quantitative antigen
Regardless of a negative pre-departure
testing (e.g.
test result, a 14-day home or facility
Chemiluminescence
quarantine is still mandatory for all
enzyme immunoassay,
international travelers.
CLEIA) but not qualitative
antigen tests such as
Within 72 hours prior to departure For travelers coming from or traveled within
some RAgT (e.g.
14 days to countries endemic to mutant
immunochromatographic
strains, facility quarantine for 3-14 days
assay)
and additional viral testing (e.g.
quantitative antigen test) at day 3 and day
Quantitative antigen tests
6 from their arrival are required.
are also utilized in airport
inspection measures
Indonesia In the island of Bali, travellers via air

transportation are required to present a
negative RT-PCR result taken within a
maximum period of 48 hours or a
negative RAgT result taken within a
maximum of 24 hours pre-departure
while travellers via land or sea
transportation are required to present a
Local travel guidelines negative RT-PCR or RAgT result within a
require travelers to
maximum period of 72 hours.
present a negative RT-PCR
or RAgT result for
Travellers to other islands of Indonesia,
domestic travel to and
from the islands of the including Java, via land private
country transportation, train commute, and sea
transportation, are encouraged to carry
out a negative RT-PCR or RAgT result
within 72 hours pre-departure. Air
travellers to these islands are required to
show their negative results from an
RT-PCR test within a maximum period of
72 hours or from a RAgT within a
maximum period of 48 hours.
Malaysia RAgTs are used in screening individuals

(with or without a valid COVID-19
Recommended the use of
Recommended the use certificate) with mild symptoms.
RAgTs for symptomatic
of RAgTs for travellers
travelers with mild
transiting from Kuala In asymptomatic individuals under
symptoms, and for
Lumpur International RT-PCR is required within 3 days or 72 quarantine, they require an RT-PCR or RAgT
asymptomatic individuals
Airport to Sabah, hours prior to departure at Day 5 (with COVID certificate) or Day 8
who acquired symptoms
Sarawak, and Labuan (without COVID certificate). The
during their quarantine
without a valid COVID asymptomatic traveler with a negative test
period
certificate result shall be released on Day 7 (with
COVID certificate) or Day 10 (without
COVID certificate).
Germany Recommended the use of Time of swab should be within 48 hours The individual Länder [federal state] are
RAgTs for all persons prior to entering Germany responsible for quarantine regulations. The
travelling to Germany, Länder have put in place their own

except for persons under regulations on the basis of a specimen
six years of age and regulation.
aircraft crews.
Travelers coming from a risk area should
undergo home (or other place of
accomodation) quarantine upon arrival
and remain isolated there for a period of
ten days. Home quarantine can be lifted
earlier with a negative result, at the earliest
after 5 days, depending on the quarantine
rules of the Federal Land.
Travelers who have spent time in an area

of variants of concern should undergo
quarantine for 14 days.
3. Diagnostic Performance
a. Evidence from Local Diagnostic/Evaluation Studies

The Research Institute for Tropical Medicine (RITM) has conducted an evaluation of rapid
antigen tests using a prospective evaluation of freshly collected respiratory swab samples from
symptomatic and asymptomatic patients. For symptomatic patients, participants must be at
least 18 years of age and with specimen collection to be done at most 5 days from symptom
onset. On the other hand, asymptomatic participants must be healthy and of the same age
without any symptoms of COVID-19. A minimum of 30 SARS-CoV-2 PCR positive and PCR
negative samples were used. Seven rapid antigen test kits were evaluated by RITM. Below
are their key findings:
● For the symptomatic cohort, sensitivity estimates were varied ranging from 27.78% to
91.43%. On the other hand, specificity estimates were high and more consistent at
95.08% to 100%. For the asymptomatic cohort, only specificity was reported. Point
estimates likewise were high ranging from 97 to 100%.
○ Symptomatic population: Among the brands tested, the Lansion Biotech Dry
Fluorescence Immunoassay had the highest overall sensitivity at 91.43%.
Meanwhile, the Lumiquick Quick Profile had the lowest sensitivity at 27.78%. In
terms of specificity, three brands (SD Biosensor Standard Q Rapid Antigen Test,
Abbott Panbio Antigen RDT, and Rapigen Biocredit COVID-19 Ag) had a point
estimate of 100%. The Lansion Biotech Dry Fluorescence Immunoassay and Quidel
Sofia SARS Antigen Fluorescence Immunoassay had the lowest specificity at
95.08% and 95.65% respectively.
○ Asymptomatic population: Six (SD Biosensor Standard Q Rapid Antigen Test, Abbott
Panbio Antigen RDT, Quidel Sofia SARS Antigen Fluorescence Immunoassay,
Rapigen Biocredit COVID-19 Ag, Lansion Biotech Dry Fluorescence Immunoassay,
and Assure Tech (Hangzhou) Fa Step) of the seven brands had specificity of 100%
while the Lumiquick QuickProfile had a sensitivity of 97% for this population group.
● A subgroup analysis at a cycle threshold value of less than 30 was also conducted by
RITM. Based on this analysis, sensitivities of the rapid antigen test kits were found to be
higher for all brands tested and less varied, with point estimates ranging from 86.36% to
100%. Of the seven, two brands (Lansion Biotech Dry Fluorescence Immunoassay and
Lumiquick Quick Profile) had sensitivities of 100% at the <30 Ct value.
b. Evidence from International Diagnostic Studies

● Based on the systematic review conducted by Burog et al. (2021), the overall pooled
sensitivity of RAgTs was 72% (95% CI: 64-78; I2: 95.77), while the specificity was 99% (95%
CI: 99-100; I2: 93.16) based on 30 studies and 10 evaluation reports. The range of point
estimates of included studies for sensitivity was from 0% to 100% while the range for
specificity was more consistent from 90% to 100%.
● Given the expected heterogeneity for pooled estimates, subgroup analysis was
pre-determined according to test brand, presence of symptoms, timing of testing, and type
of specimen used.
○ Based on 11 studies (n = 16060) with moderate to high methodological quality, the

BinaxNOQ COVID-19 Card (Abbott Diagnostics) test kit showed the highest pooled
sensitivity at 90% (95% CI: 0.66 to 0.93). Other test brands that had 80% sensitivity or
higher were the following: NowCheck COVID-19 Ag Test (Bionote Inc) at 89% (95% CI:
81 to 95), VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Test at 80% (95%
CI: 74 to 90), and Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit at 80% (95% CI: 62
to 91; I2=0%).
○ In terms of presence of symptoms, pooled sensitivity of RAgTs was higher among
symptomatic patients (78%; 95% CI: 69-86; 30 studies) than in asymptomatic patients
(51%; 95% CI: 39-63 7 studies).
○ When the test was used for testing patients in the early phase (0-7 days) of the
disease, pooled sensitivity estimate was found to be 71% (95% CI 44-89; 12 studies)
compared to 65% (95% CI: 57-71; 2 studies ) when used in patients in the late phase
(8-14) of the disease. The reviewers also noted that this needs further validation
studies as the number of participants and studies included in the late phase was small
(n=831).
○ In terms of the specimen used, anterior nares swab specimens alone showed the
highest pooled sensitivity of 84% (95% CI: 66-93; 15 studies) followed by
nasopharyngeal swabs with sensitivity of 72% (95% CI: 65-78; 36 studies). Saliva
specimens had the lowest pooled sensitivity at 17% (95% CI: 13-23; 2 studies).
● The methodological quality of included studies was rated to be moderate by the review
authors. Four studies were found to have high quality while 16 studies and 10 evaluation
reports were found to have moderate quality and 10 studies were found to have a low
quality.
C. Household Financial Impact

While the HTAC has recommended the use of RAgTs for specific use cases since October 2020,
the Philippine Insurance Corporation (PhilHealth) does not have yet an existing coverage
mechanism for the cost of rapid antigen testing. As far as COVID-19 testing is concerned, they
are only covering the cost of RT-PCR testing, to date.
In addition, there is no price ceiling for rapid antigen testing yet, although the DOH and the
Department of Trade and Industry (DTI) are currently forming a technical working group to set
the price ceiling. Based on their initial survey, the median costs of rapid antigen testing (based
on charge) are PhP 700 and PhP 1,000 for non-hospital-based and hospital-based government
facilities, respectively. Among the private institutions, the median costs (based on charge)
recorded are PhP 1,500 and PhP 1,800 for non-hospital-based and hospital-based facilities,
respectively.
D. Cost-effectiveness
The evidence was not reviewed. A full-blown cost-effectiveness analysis is currently not done for
rapid reviews under a pandemic situation due to its emergency nature. A full blown
cost-effectiveness analysis that takes on a societal perspective (i.e., including the economic and
social impacts) will be performed once sufficient evidence is available and when full market
authorization has been granted.
E. Affordability and viability
As mentioned, the initial survey of DOH and DTI on the cost of rapid antigen in the Philippines
shows that the median costs of rapid antigen testing (based on charge) are PhP 700 and PhP
1,000 for non-hospital-based and hospital-based government facilities, respectively. Among the
private institutions, the median costs recorded (based on charge) are PhP 1,500 and PhP 1,800
for non-hospital-based and hospital-based facilities, respectively.
V. Recommendations (as 27 September 2021)
A. The HTAC maintains that RT-PCR remains the standard diagnostic test for COVID-19,
and would like to emphasize that the following interim recommendations on rapid antigen
testing are subject to change pending new evidence.
B. We reiterate the previous HTAC recommendation that rapid antigen tests when positive
are most useful in immediately identifying COVID-19 cases and therefore can be used to
initiate contact tracing, epidemiological surveillance and clinical management. In Table
2, HTAC recommends the use cases, intended population, sample specimen,
interpretation of results, repeat antigen testing and contact tracing.
Table 2. HTAC Recommendations for Rapid Antigen Testing

Recommended The HTAC does not recommend the use of rapid antigen tests for
Use Cases indiscriminate use in mass screening, for return-to-work clearance and
[UPDATED] for COVID-19 diagnosis in individuals with low index of suspicion (i.e.,
asymptomatic and no history of exposure).
Rapid antigen tests are currently recommended by HTAC only for very
specific purposes:
● For targeted screening and diagnosis of suspected and
probable cases of COVID-19 (i.e., with a high index of
suspicion), meeting the clinical and/or epidemiologic criteria in
the hospital or community settings as defined below:
● Suspected cases of COVID-19 are individuals:
○ with acute onset of the following signs and
symptoms adopted on the WHO clinical criteria,
(Fever, cough, general weakness/fatigue,
headache, myalgia, sore throat, coryza, dyspnea,
anorexia/nausea/vomiting, diarrhea, altered
mental status, anosmia (loss of smell) or ageusia

(loss of taste)) OR
○ satisfying the following epidemiology criteria):
■ Residence or work in an area with high risk
of transmission of virus (e.g. congregate
settings)
■ Residence or travel to an area with
community transmission
■ Work in any healthcare setting
● Probable cases of COVID-19 are:
○ Individuals meeting the above clinical criteria
AND is a contact of a probable or confirmed
case or linked to a cluster of COVID-19 cases
○ Suspect cases with chest imaging suggestive of
COVID-19
○ Individuals with sudden onset of anosmia (loss
of smell) or ageusia (loss of taste) in the
absence of any other identified cause.
○ Death,
(1) not otherwise explained;
AND
(2) in an adult with respiratory distress
preceding death;
AND
(3) was:
(a) contact of a probable or
confirmed case; OR
(b) linked to a COVID-19 cluster.
(Note: Added fourth criterion was also included in
the WHO definition of probable COVID-19 case
dated 07 August 2020)
● For testing of patients in the hospital setting, where the

turnaround time is critical, to guide patient cohort management in
order to minimize transmission of COVID 19 among healthcare
workers and other patients. (Hospitals are high-risk settings
among healthcare workers and patients.) Otherwise, use RT-PCR
in case of elective procedures;
● For targeted screening and diagnosis of suspect and probable

cases of COVID-19 (as defined above) in presumptive outbreaks
where the result of the RT-PCR test of a one suspect case has not
yet been released and in settings where RT-PCR is not
immediately available or when delayed release of result or
prolonged turnaround time is expected (i.e., more than 48 hours).
● For local border screening at points of entry for individuals

travelling from areas:
○ with a confirmed outbreak (DC 2020-0397);
○ with a suspected outbreak (Interim Guidance Document on
Cholera Surveillance, 2017);
○ with a presumptive outbreak (where the result of the RT-PCR
test of one suspect case has not yet been released, and in
settings where RT-PCR is not immediately available, where
delayed release of the result, or a prolonged turnaround time
is expected based on HTAC Recommendation on the used of
Rapid Antigen Test published April 2021);
○ classified as moderate or high-risk based on average daily
attack rate /Two Week Growth Rate (ADAR/2WGR), or as
reported by the DOH-Epidemiology Bureau for areas under
Alert Level 1 to 4; and,
○ with unknown ADAR/2WGR even if fully vaccinated (wherein
high prevalence/incidence can be assumed due to some
localized reported and/or unreported outbreaks).
● For local border screening of working individuals who cross
borders at least 2-3 times per week, results of RAgT should be
valid within 48 hours after the conduct of the test.
Intended ● In general, the RAgT can be used for individuals with a high index
Population of suspicion:
[UPDATED] ○ Symptomatic individuals with or without known exposure
(For symptomatic individuals, RAgT is recommended to be
performed within the first 5-7 days after the onset of
symptoms for best results.)
○ Asymptomatic individuals with exposure (For
asymptomatic individuals with exposure, the RAgT is
recommended to be performed from 4 to 11 days after
exposure, even before symptoms develop.)
● The RAgT is not recommended for use by individuals with a low

index of suspicion (i.e., asymptomatic individuals without history
of exposure)
WITH history of WITHOUT history of
exposure exposure
HIGH index of HIGH index of
suspicion: suspicion:
WITH symptoms Recommended for Recommended for
rapid antigen testing rapid antigen testing
LOW index of
HIGH index of suspicion:
WITHOUT symptoms suspicion: NOT recommended for
Recommended for rapid antigen testing
rapid antigen testing
Applicable to guide
patient cohort
management to
minimize transmission
of COVID 19 to
healthcare workers and
other patients
● The intended population for RAgT includes individuals with the

following exposure:
○ People in close contact with a suspected, probable or
confirmed case (e.g., household members, workmates).
Examples would be:
- Face-to face contact with a suspected, probable or
confirmed case within 1 meter and for at least 15
minutes;
- Direct physical contact with a suspected, probable or
confirmed case;
- Direct care for a patient with probable or confirmed
COVID-19 disease without using recommended
personal protective equipment;
- Other situations as indicated by local risk
assessments
- Note: Window of exposure to suspected, probable or
confirmed case is anywhere between 2 days before
or within 14 days of onset of symptoms.
○ People coming from the following areas:

■ with a confirmed outbreak (DC 2020-0397);
■ with a suspected outbreak (Interim Guidance
Document on Cholera Surveillance, 2017);
■ with a presumptive outbreak (where the result of
the RT-PCR test of one suspect case has not yet
been released, and in settings where RT-PCR is not
immediately available, where delayed release of the
result, or a prolonged turnaround time is expected);
■ classified as moderate or high-risk based on
average daily attack rate /Two Week Growth Rate
(ADAR/2WGR), or as reported by the
DOH-Epidemiology Bureau for areas under Alert
Level 1 to 4; and,
■ with unknown ADAR/2WGR even if fully vaccinated
(wherein high prevalence/incidence can be
assumed due to some localized reported and/or
unreported outbreaks)
○ People residing in the following areas:

■ closed or semi-closed institutions (as defined in
DM 2020-0468),
■ crowded areas (i.e., more than one person per
three square meter circular area or those sharing
common facilities) with presumptive outbreak (as
defined above) or confirmed outbreaks (per DC
2020-0397)
■ areas with a high positivity rate (i.e., >5%, in
accordance with WHO standards) averaged over a
seven-day period
○ People working in areas with presumptive outbreak (as

defined above) or confirmed outbreaks (per DM
2020-0397)
● If sufficient testing capacity is available, serial rapid antigen

testing at least weekly in congregate settings (e.g., workplaces,
prisons, nursing homes) with moderate transmission and at least
twice weekly for areas with substantial or high community
transmission is recommended (US CDC Interim Guidance for
SARS-CoV-2 Testing and Screening at Institutions of Higher
Education, 2021).
● Finally, the HTAC does not recommend the use of RAgTs to

issue clearances for return to work or for earlier release from
quarantine because of the likelihood of false negatives.
Sample Specimen The specimens to be collected for RAgT must be nasal, nasopharyngeal
and/or oropharyngeal swabs.
Interpretation of ● It is recommended that individuals with positive rapid antigen

Results test results (positive for COVID-19) be isolated and managed as
COVID-19 cases.
● For individuals with a high index of suspicion and who tested
negative using rapid antigen tests should be isolated until they
can be confirmed negative by RT-PCR or repeat antigen results
(DM 2021-0169).
○ The confirmatory RT-PCR test for those who tested with
negative rapid antigen test result should be done at least
within 48-72 hours from the initial antigen test. It is
important to always correlate the test results with the
overall clinical and epidemiological context (e.g., history
of exposure). The previous recommendation was for a
confirmatory RT-PCR test for those who test negative.
However, this was found impractical in community

settings where RT-PCR laboratories may not be accessible.
Other Other overarching recommendations of the HTAC are as follows:

recommendations ● Publicize standards on diagnostic performance to address the
observed wide variability of performance in all COVID-19 testing
kits in the market
● Strengthen system for monitoring and evaluation of compliance
of manufacturers to regulatory standards and post-marketing
requirements. Departmental constraints must be addressed to
enable strict compliance and to add teeth to implementation.
● Testing (using RAgTs or NAATS) should be used in addition to
other health measures such as minimum public health standards
(including the use of face masks/face shields), physical
distancing, ventilation, quarantining/isolation, symptom-based
screening and contact tracing
● The HTAC is actively on the watch for evidence as it is rapidly
evolving, and shall update its recommendation when new
information becomes available.
C. The HTAC likewise maintains its previously recommended minimum sensitivity and
specificity which are 80% and 97% for Rapid Antigen Tests, respectively. These were
adapted from the UK Medicines & Healthcare products Regulatory Agency and the World
Health Organization Interim Guidance. Further to this, RAgT must also satisfy the
following 2021 recommended minimum regulatory, technical and operational
specifications set by the HTAC found in Table 3.
Table 3. Recommended specifications for RT-PCR kits using NPS/OPS and saliva specimens
Parameter Requirement Requirement
(HTAC recommendation 2020) (updated as of 19 April 2021)
Regulatory Must have a certificate of product Must have a certificate of product

Requirement registration (CPR) or emergency registration (CPR) or emergency
authorization (EA) from the FDA authorization (EA) from the FDA
Philippines Philippines
Test kit It is desirable that rapid antigen test kits It is desirable that rapid antigen test kits
package content contain all materials and accessories contain all materials and accessories
necessary for the procedure. necessary for the procedure.
Result output Qualitative, result must be read visually Qualitative, result must be read visually or
or with a reader but must be operable with a reader but must be operable using
using batteries batteries
Human resource Less than half a day to no additional Minimum of 4-hour long training needed
training training needed for healthcare for healthcare professionals to be able to
professionals to be able to optimize optimize performance Training module

performance available at WHO
(https://extranet.who.int/hslp/content/sar
s-cov-2-antigen-rapid-diagnostic-test-trai
ning-package)
Biosafety Can be done without the need for BSL 2 Can be done without the need for BSL 2 or
concerns or 3 facilities, provided that there is 3 facilities, provided that there is evidence
evidence that the live virus was that the live virus was deactivated early in
deactivated early in the process the process
Clinical At least 80% sensitivity At least 80% sensitivity

Sensitivity
A useful assessment is the sensitivity of A useful assessment is the sensitivity of
the test in patients with a rRT-PCR cycle the test in patients with a rRT-PCR cycle
threshold (Ct) below a specific value threshold (Ct) below a specific value (e.g.,
(e.g., 28 or 30) 28 or 30)
Clinical At least 97% specificity At least 97% specificity

Specificity
Processing Time Less than 2 hours from sample Less than 2 hours from sample collection
collection to result to result
Reference In-house laboratory RT-PCR test or if In-house laboratory RT-PCR test or if

Standard commercial RT-PCR test, must adhere to commercial RT-PCR test, must adhere to
the specification stipulated in the HTAC the specification stipulated in the HTAC
Guidance Document on RT-PCR test kits Guidance Document on RT-PCR test kits
Sample Positive samples: minimum of 30 Positive samples: minimum of 30 positive

Requirement in positive specimens specimens
Validation Negative samples: 30 negative Negative samples: 30 negative specimens
Studies specimens
Include details such as:
Include details such as: ● specimen type
● specimen type ● specimen collection date
● specimen collection date ● date of onset of symptoms (if
● date of onset of symptoms (if present)
present) ● date of PCR testing
● date of PCR testing ● severity of symptoms (if known)
● severity of symptoms (if known) ● tests used to identify COVID19
● tests used to identify COVID19 patients, etc.
patients, etc.
Requirement for Must have been validated by an RAgTs must be authorized by the
Independent independent or a third-party reputable Philippine Food and Drug Administration,
Validation government or private research and validated by any of the following:
institution including but not limited to ● Research Institute for Tropical
the following: Medicine (RITM)
● Research Institute for Tropical ● US Food and Drug Administration
Medicine (RITM) (US-FDA)
● UP National Institutes of Health ● World Health Organization,

(NIH) Foundation for Innovative New
● US Food and Drug Diagnostics (WHO-FIND)
Administration (US-FDA) ● Therapeutic Goods Administration
● World Health Organization, (TGA, Australia)
Foundation for Innovative New ● Medicines and Healthcare
products Regulatory Agency
Diagnostics (WHO-FIND)
(MHRA, UK)
● Therapeutic Goods
● Japan Pharmaceuticals and
Administration (TGA, Australia) Medical Devices Agency
● Medicines and Healthcare ● Other DOH-designated institutions
products Regulatory Agency for test kit validation recognized
(MHRA, UK) by RITM in its letter to the
● Japan Pharmaceuticals and Secretary of Health dated 01 April
Medical Devices Agency 2021 (Annex A) unless these
laboratories are developing their
own test kits
Transport and The storage and working temperature The storage and working temperature can
Storage can be 18 to 30 °C. It should be used in be 18 to 30 °C. It should be used in a
Requirements a controlled environment. controlled environment.
Shelf-Life Shelf-life should not be shorter than Shelf-life should not be shorter than
twelve (12) months at the time of twelve (12) months at the time of delivery
delivery
Calibration If calibration is required, it can be done If calibration is required, it can be done

Requirement onsite onsite
Cost of test kit The cost of the RAgT kit should be The total cost of the initial and possible
[Updated] significantly less than the cost of the repeat testing using the RAgT kit should
RT-PCR test kit not exceed the government price cap for
Rapid Antigen Testing based on DOH
Department Circular 2021-0323 (i.e., Php
960.00).
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VI. Annexes
Table 4. Comparison of Target Product Profiles for RAgTs
Parameter US FDA UK MHRA WHO
Acceptable Desirable Acceptable Desirable
Intended Use No specific requirement Aid in triage of current Aid in triage of current In areas with confirmed SARS-CoV-2 community wide
SARS-CoV2 infection by SARS-CoV-2 infection by transmission or confirmed outbreaks in closed or
detection of SARSCoV-2 detection of SARS-CoV-2 semi-closed communities and in high risk groups:
nucleic acids or antigens nucleic acids or antigens Early detection of SARS-CoV-2 cases where
in samples from people in samples from people molecular/ reference assays are not available or
of all ages during the of all ages at any point services are overloaded, leading to turnaround times
acute phase of infection. during active infection. that are not useful for guiding clinical case
management and infection control measures. In
suspected SARS-CoV-2 outbreak situations: multiple
positive cases highly suggestive of SARS-CoV-2
Monitor trends in disease incidence
Target Population No specific requirement People with clinical signs People with or without Patients with acute or subacute respiratory
and symptoms clinical signs and symptoms or fever or other suspicious symptoms
associated with symptoms associated (diarrhoea, anosmia) and either a known contact with
SARS-CoV-2 infection. with SARS-CoV-2 a confirmed or probable COVID-19 patient or living in
infection, if testing is an area of cluster or community transmission, and
appropriate. close contacts (with or without symptoms) of index
patients (confirmed COVID-19 patients).
Turnaround time No specific requirement Less than 2 hours from Less than 30 minutes ≤ 40 minutes ≤20 minutes
sample to result from sample to result
Number of No specific requirement Single SARS-Cov-2 RNA Dual (or more) SARS-CoV biomarker SARS-CoV-2 only
antigens to be or antigen target SARS-CoV-2 RNA or (e.g. RNA, biomarker (e.g. RNA,
detected antigen targets protein/antigen(s) protein/antigen) specific
specific for acute e.g. for acute and subacute
first week after onset of e.g. first two weeks after
symptoms /current onset of
infection (assumption symptoms/current
that SARS-CoV-1 is not infection
circulating)
Specimen No specific requirement Nasopharyngeal or Sputum, saliva or other Nasopharyngeal, Anterior nares,
oropharyngeal swabs, method not using oropharyngeal swab (or saliva/oral fluid, sputum
lower respiratory tract invasive swab wash) nasal swab
aspirates, (anterior nares or
bronchoalveolar lavage, mid-turbinate), nasal
nasopharyngeal wash, sputum
wash/aspirate or nasal
aspirate
Clinical Sensitivity If you intend to seek a Greater than 80% (within Greater than 97% (within ≥ 80% ≥90%
claim for saliva, oral fluid, 95% confidence intervals confidence intervals of
blood, or other specimen of 70-100%) 93-100%) The targets are for the The targets are for the
types, you should test at estimated true sensitivity estimated true sensitivity
least 30 positive and specificity; therefore, and specificity; therefore,
specimens with paired the lower bound of the lower bound of
polymerase chain confidence intervals confidence intervals
reaction (PCR) results should ideally equal or should ideally equal or
from an NP swab. exceed the target. exceed the target.
Clinical Specificity Greater than 95% (within Greater than 99% (within ≥ 97% >99%
95% confidence intervals confidence intervals of
of 90-100%) 97-100%) The targets are for the The targets are for the
estimated true sensitivity estimated true sensitivity
and specificity; therefore, and specificity; therefore,
the lower bound of the lower bound of
confidence intervals confidence intervals
should ideally equal or should ideally equal or
exceed the target. exceed the target.
Sample size You should confirm the Clinical sensitivity: At least 150 positive clinical None mentioned None mentioned
performance of your samples. The samples should cover a clinically
assay by testing a meaningful range of viral loads (i.e. should be from
minimum of 30 positive people with high, medium and low viral load) that
specimens and 30 represents the population the test is intended to be
negative specimens in a used in. For tests with lower sensitivity, it is
randomized blinded envisaged that when used in practice people with
fashion negative results will need confirmatory checking by
an additional test.
Clinical specificity: At least 250 negative clinical
samples. For tests with lower specificity, it is

envisaged that when used in practice people with
positive results will need confirmatory checking by an
additional test.
Comparator test We recommend only A validated CE marked A composite clinical Determination of sensitivity and specificity should be
using an EUA test with laboratory method in reference standard or against an approved/authorised by a stringent
high sensitivity and current clinical use, dPCR reference method. regulatory authority (SRA), molecular-based
reverse transcription against which the COVID-19 assay7.Product assessment of clinical
polymerase chain Negative/Positive specificity must include patients/samples with other
reaction (RT-PCR), which Percent Agreement is human coronaviruses and pathogens in differential
uses a chemical lysis calculated diagnosis for presenting signs/symptoms.
step followed by solid
phase extraction of
nucleic acid (e.g., silica
bead extraction) as the
comparator method. The
comparator method
should be one of the
more sensitive RT-PCR
assays authorized by
FDA. We encourage you
to review the results
from the FDA
SARS-CoV-2 Reference
Panel available here
when selecting your
comparator method; we
strongly recommend you
contact us to discuss
your choice of
comparator assay.
Storage ● FDA considers Storage of kit and No cold chain (15 to 30° 12 months4 at 4-30°C; 18-24 months at 4-40°C;
temperature 15-30°C to reagents at 2-8° C for at C). tolerates brief periods > tolerates freezing and
represent room least 12 months. Stable 40°C; humidity 75%+ 5% brief periods > 45°C;
temperature for 12 hours once any associated humidity 75%+ 5%.; any
conditions. Ideally, removed from cold equipment must meet or associated equipment
you should evaluate storage. exceed these must meet or exceed
stability at both requirements. these requirements.
15°C and 30°C;
Operating however, for the 15 to 30° C 15 to 30° C 15-35°C; 25-80% relative 10-40°C; 25-90% relative
conditions purposes of the humidity up to 1500m. humidity up to 3000m.

(temperature, EUA evaluation, we
humidity, etc.) believe 30°C is
acceptable as it
represents the
worse-case
scenario.
● Unopened kit
Shelf-Life Stability:
a. You should
evaluate real-time
kit stability studies
with unopened kits
stored at the
claimed storage
temperature for
your test.
b. Accelerated
stability evaluations
for unopened kits
can be included for
EUA submissions
while the real-time
studies are
on-going.
● Unopened kit
Shipping Stability:
Study should
evaluate the
anticipated
handling and
shipping times and
temperatures
expected for
unopened kits.
● In-use/Opened Kit
Stability: Depending
on your device, your
stability study
design should also
support in-use
stability of the kit
reagents once the

kit has been
opened, e.g.,
storage at 2-8°C for
7 days. This
includes on board
stability once
reagents have been
placed on the
instrument (if
applicable).
Biosafety No specific requirement Standard PPE and safety Standard PPE and safety Standard respiratory Tests that minimize the
procedures need to be procedures need to be sample collection safety need for biosafety
followed. No need for followed. No need for precautions requirement are strongly
BSL 2 or 3 laboratory BSL 2 or 3 laboratory recommended, and all preferred e.g. with a
facilities. Evidence that facilities. Evidence that materials are free of self-sample collection
live virus is deactivated live virus is deactivated components with a GHS device with virus
early in the process. early in the process. classification H inactivation
(particularly H350, H340,
H360)8

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Evidence Summary on the Use of Rapid

Antigen Test Kits for the Diagnosis of

Service Line Evidence Summary

Publication Date 27 September 2021

Summary Length 33 Pages

Prepared by Health Technology Assessment Council

Contact details [email protected] | 8-875-7734 loc. 260 or 258

Acronyms Used in the Evidence Summary

Australia PHLN Australia Public Health Laboratory Network

Australia TGA Australian Therapeutic Goods Administration

DOH Department of Health (Philippines)

ECDC European Center for Disease Prevention and Control

FIND Foundation for Innovative New Diagnostics

Japan MHLW Ministry of Health, Labor, and Welfare of Japan

NPS Nasopharyngeal Swab

OPS Oropharyngeal Swab

PHAC Public Health Agency of Canada

PhilHealth Philippine Health Insurance Corporation

RITM Research Institute for Tropical Medicine

SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2

UK MHRA United Kingdom Medicines and Health Products Regulatory Agency

US FDA United States of America Food and Drug Administration

WHO World Health Organization

Acronyms Used in the Evidence Summary 2

II. Policy Question 5

III. Research Questions 5

IV. Evidence Considered 5

A. Responsiveness to Disease Magnitude, Severity, and Equity 5

B. Safety and Effectiveness 6

a. Evidence from Local Diagnostic/Evaluation Studies 14

b. Evidence from International Diagnostic Studies 14

C. Household Financial Impact 15

E. Affordability and Viability 16

V. Recommendations (as of 30 April 2021) 16

II. Policy Question

III. Research Questions

3. Global guidelines and position on use of RAgTs

IV. Evidence Considered

A. Responsiveness to Disease Magnitude, Severity, and

B. Safety and Effectiveness

communities, in areas with widespread community transmission, and in testing

▪ A separate section is presented for the review of guidelines mentioning the

asymptomatic interzonal domestic travelers (with no established exposure/contact to a

US CDC Nucleic acid amplification test or antigen

UK Recommended the use of antigen tests such as

Indonesia In the island of Bali, travellers via air

Malaysia RAgTs are used in screening individuals

travelling to Germany, Länder have put in place their own

Travelers who have spent time in an area

a. Evidence from Local Diagnostic/Evaluation Studies

b. Evidence from International Diagnostic Studies

○ Based on 11 studies (n = 16060) with moderate to high methodological quality, the

C. Household Financial Impact

E. Affordability and viability

V. Recommendations (as 27 September 2021)

Table 2. HTAC Recommendations for Rapid Antigen Testing

mental status, anosmia (loss of smell) or ageusia

● For testing of patients in the hospital setting, where the

● For targeted screening and diagnosis of suspect and probable