Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY
May 29, 2020

DEPARTMENT MEMORANDUM
N0. 2020 -

TO: ALL UNDERSECRETARIES AND ASSISTANT SECRETARIES'

DIRECTORS OF BUREAUS AND CENTERS FOR HEALTH
DEVELOPMENT' MINISTER OF HEALTH — BANGSAMORO
AUTONOMOUS REGION IN MUSLIM MINDANAO:
EXECUTIVE DIRECTORS OF SPECIALTY HOSPITALS AND
NATIONAL NUTRITION COUNCIL' CHIEFS OF MEDICAL
CENTERS HOSPITALS SANITARIA AND INSTITUTES'
PRESIDENT OF THE PHILIPPINE HEALTH INSURANCE
CORPORATION' DIRECTORS OF PHILIPPINE NATIONAL
AIDS COUNCIL AND TREATMENT AND REHABILITATION
CENTERS AND ALL OTHERS CONCERNED

SUBJECT: Updated Interim Guidelines on Expanded Testing for COVID-19

INTRODUCTION

With the increasing number of cases and deaths in various territories, the World Health
Organization declared Coronavirus disease 2019 (COVID-l9) as a pandemic last March
11, 2020.

In response to this pandemic, the Inter-Agency Task Force on Emerging Infectious

Diseases (IATF-EID) National Action Plan set forth the “Detect, Isolate, and Treat”
strategies to mitigate, identify, contain, and manage the disease. However, the increasing
number of suspect, probable, and confirmed cases COVID-l9 cases and close contacts in
the country also entails the subsequent increase in the demand for RT-PCR testing.

Cognizant of the increasing capacity of COVID-l9 testing in the country, the Department
of Health issues these updated guidelines on the expanded risk-based testing for
COVID-19 to cover all individuals who are at-risk of contracting the disease.

II. GENERAL GUIDELINES

1. COVlD-19 Expanded Testing is defined as testing all individuals who are at-risk of
contracting COVID-19 infection. This includes the following groups: (1) suspect
cases or (2) individuals with relevant history of travel and exposure (or contact),
whether symptomatic or asymptomatic, and (3) health care workers with possible
exposure, whether symptomatic or asymptomatic.

a. The following exposures should have happened two (2) days before or within 14
days from onset of symptoms of a confirmed or probable case:
1) Face-to-face contact with a confirmed case within 1 meter and for more than
15 minutes

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 2) Direct physical contact with a confirmed case
3) Direct care for a patient with probable or confirmed COVID-l9 disease
without using proper personal protective equipment

b. Indiscriminate RT-PCR testing beyond close contacts of a confirmed COVID-l9

case is not recommended.

2. The following reflects the sub-groups of at-risk individuals arranged in order of

greatest to lowest need for testing:

a. Subgroup A: Patients or healthcare workers with severe/critical symptoms,

relevant history of travel/contact

b. Subgroup B: Patients or healthcare workers with mild symptoms, relevant

history of travel/contact, and considered vulnerable. Vulnerable populations
include those elderly and with preexisting medical conditions that predispose
them to severe presentation and complications of COVID-l9.

c. Subgroup C: Patients or healthcare workers with mild symptoms, relevant history

of travel/contact

d. Subgroup D: Patients or healthcare workers with no symptoms but relevant

history of travel/contact

e. Subgroup E. Frontliners indirectly involved in health care provision in the

response against COVlD-l9 which includes, but not limited to the following:
i. Personnel manning the Temporary Treatment and Quarantine Facilities
(LGU- and Nationally—managed);
ii. Personnel manning Quarantine Control Points, including those from Armed
Forces of the Philippines, Bureau of Fire Protection, and others;
iii. National/Regional/Local Risk Reduction and Management Teams;
iv. Barangay Health Emergency Response Teams and barangay officials
providing barangay border control and performing COVID-l9-related tasks;
v. Personnel of Bureau of Corrections and Bureau of Jail Penology and
Management;
vi. Personnel manning the One-Stop-Shop in the Management of the Returning
Overseas Filipinos;
vii. Personnel serving at the COVID-19 swabbing center; and
viii. Social workers providing amelioration and relief assistance to communities
and performing COVID-19-related tasks.

f. Subgroup F. Other vulnerable patients such as those with comorbidities, those

who will undergo high-risk, elective surgical procedures, those living in confined
spaces such as persons deprived of liberty or institutionalized persons, and
others. These also include:

i. Pregnant patients who shall be tested during the peripartum period;

ii. Dialysis patients and patients who are immunocompromised, such as those
who have HIV/AIDS, inherited diseases that affect the immune system,
those in chemotherapy or radiotherapy, who shall be tested at the discretion
 of the attending physician, following the existing guidelines of Philippine
Society for Microbiology and Infectious Diseases.

Due to global shortage of testing kits and other supplies, and limitation in local
capacity for testing, there is a need to rationalize available tests and prioritize
subgroups A and B.

However, in view of the expansion of testing capacity and to ensure healthcare

workforce safety, subgroup C will be tested and health workers prioritized.

All subnational laboratories are directed to allocate between 20-30% of their daily
testing capacity for health workers and the remaining 70%-80% for patients.

Based on current available evidence, real-time polymerase chain reaction (RT-PCR)

testing is the confirmatory test for diagnosis. In the Philippines, this pertains to using
RT-PCR test kits that are approved by the Food and Drug Administration (FDA), and
validated by the Research Institute for Tropical Medicine (RITM).

Rapid antibody-based test kits shall not be used as standalone tests to definitively
diagnose or rule out COVID-l9. Because these must be used in conjunction with
RT-PCR, care must be exercised to not unduly consume RT-PCR test kits for the sake
of confirmation.

Reporting of confirmed cases shall continue to be based on RT-PCR testing, in

accordance with Administrative Order 2020-0013, entitled “Revised AO2020-0012
Guidelines for the Inclusion of COVID-l9 in the List of Notifiable Diseases for
Mandatory Reporting to the Department of Health dated 17 March 2020”. Reporting
of the full line list of positive and negative specimens from the start of the operations
shall adhere to Administrative Order 2020-0014-A entitled, “Guidelines in Securing a
License to Operate a COVID-l9 Testing Laboratory in the Philippines.”

Discharge and recovery criteria for suspect, probable, and confirmed COVID-19
cases shall no longer entail repeat testing. Symptomatic patients who have clinically
recovered and are no longer symptomatic for at least 3 days and have completed at
least 14 days of isolation either at home, temporary treatment and monitoring facility,
or hospital, can be tagged as a recovered confirmed case and reintegrated to the
community without the need for further testing, provided that a licensed medical
doctor clears the patient. Patients who test RT-PCR positive and remain asymptomatic
for at least 14 days can discontinue quarantine and tagged as a recovered confirmed
case without need for further testing, provided a licensed medical doctor clears the
patient.

10. Only antibody-based test kits approved by the FDA and locally-validated by the
RITM or the Department of Science and Technology or those with acceptable
performance of >90% sensitivity and >95% specificity validated by World Health
Organization-Foundation for Innovative New Diagnostics (WHO-FIND) may be
used.

ll. Disposal of test kits, including PPEs and other materials used in testing, shall adhere
to the 4th Edition of Health Care Waste Management Manual.
 12. Expanded use of antibody-based test kits through validation and sew-epidemiological
studies shall be explored for Subgroup D, as testing all asymptomatic contacts of
confirmed cases using RT-PCR is not recommended until there is surplus testing
capacity. Antibody tests, particularly validated ELISA tests, can be used for
community seroprevalence surveys to gauge the status of infection in a community
using appropriate sampling methodologies.

13. Results of such validation and sero-epidemiological studies shall be submitted to

DOH, and to the Health Technology Assessment Council (HTAC) for their review
and consideration. This should inform fiiture prospects of financing of DOH and
PhilHealth since both agencies may only finance or reimburse COVID-19 test kits
that have been positively recommended by the HTAC as required by RA No. 11223
or the Universal Health Care Act.

III. SPECIFIC GUIDELINES

A. The following guidelines shall apply once the FDA-approved antibody-based test kits
have been locally-validated by the RITM or the Department of Science and Technology
or those with acceptable performance of >90% sensitivity and >95 % specificity validated
by WHO-FIND:
1. Only licensed medical doctors may request, administer, and interpret results of rapid
antibody-based tests. Other licensed health professionals may administer the rapid
antibody tests, provided that they wear appropriate PPEs and they are supervised by
licensed medical doctorThe medical doctor shall be responsible for:
a. wearing appropriate personal protective equipment provided by the health
institution, prior to administering test;
b. following DOH published guidelines on case management;
c. filling online Case Investigation Form for each tested individual and
coordinating with regional epidemiological surveillance unit;
d. monitoring and reporting adherence to case management on a daily basis using
the online form provided by the DOH to be submitted to
[email protected] (Annex A) or through COVID CART
(detectcoviddohgovph);
e. referring antibody-based test positive cases which belong to Subgroup A and B
for possible admission to hospital and confirmatory testing for RT-PCR; and
referring antibody-based test positive cases which belong to other subgroups for
possible admission to temporary treatment and monitoring facilities; and
f. Issuing official receipt to the patient for the services rendered.

Failure to comply with the above mentioned responsibilities may be considered

Violation of RA 11332, which penalizes “non-cooperation of persons and entities
that should report and/or respond to notifiable diseases or health events of public
concern”, penalty of which is fine not less than Php 20,000 but not more than Php
50,000 or imprisonment of not less than one month but not more than 6 months, or
both such fine and imprisonment, and other applicable laws, rules and regulations.
B. For Symptomatic Patients

1. Testing of all symptomatic patients who are close contacts of a confirmed or probable
case must be conducted by health workers equipped with proper Personal Protective
Equipment. Patients must be isolated at all times.
Testing of symptomatic patients who are close contacts of a confirmed or probable case
with rapid antibody-based test kits alone is not recommended. If there is no available
RT—PCR, validated rapid antibody-based testing that detects both IgM and IgG may be
used. However, regardless of results, patients should remain isolated for 14 days or
until asymptomatic, whichever is longer (Annex B).
a. If IgM negative, collect samples for RT-PCR testing
i. If RT—PCRnegative, the patient is not a COVID-l9 case but has to
complete the 14-day quarantine.
ii. If RT-PCR positive, the patient is a confirmed COVID-l9 case and shall
be treated and undergo isolation accordingly.
iii. If RT—PCR testing is not available, isolate the patient for 14 days or until
asymptomatic, whichever is longer.
1. If the initial IgG positive, the patient can be released from
is
quarantine once 14 days is completed or asymptomatic, whichever
is longer. If the initial IgG is negative, repeat rapid antibody-based
testing once asymptomatic or after 14 days, whichever is longer.
2. If results on repeat testing are IgG positive, regardless of IgM
result, patients can be released from quarantine.

3. If results on repeat testing are IgM and IgG negative, patients can
be released from quarantine.

4. If results on repeat testing are IgM positive and IgG negative,

extend quarantine by seven-day increments and repeat testing. If
persistently IgM positive but IgG negative for two consecutive
retestings after the lst 14 day period, consider potential false
positives and confer with infectious diseases specialists.

b. If IgM positive, the patient is a probable COVID-19 case. Collect swab for
RT-PCR testing.

If RT—PCR positive, the patient confirmed COVID-l9 case and shall

is a
be treated and undergo isolation accordingly.

ii. If RT—PCR negative, the patient has to complete the 14-day quarantine or
until asymptomatic whichever is longer and repeat rapid antibody-based
test once asymptomatic.

1. If results on repeat testing are IgG positive, regardless of IgM

result, patients can be released from quarantine.
 2. If results on repeat testing are still IgM positive and IgG negative,
extend quarantine by seven-day increments and repeat testing. If
persistently IgM positive but IgG negative for two consecutive
retestings after the lst 14 day period, consider potential false
positives and confer with infectious diseases specialists.

iii. If RT-PCR testing is not available, isolate for 14 days or once

asymptomatic whichever is longer. Repeat rapid antibody-based testing
once asymptomatic or at 14 days of quarantine whichever is longer;

1. If results on repeat testing are IgG positive, regardless of IgM

result, patients can be released from quarantine.

2. If results on repeat testing are still IgM positive and IgG negative,
extend quarantine by seven-day increments and repeat testing. If
persistently IgM positive but IgG negative for two consecutive
retestings after the lst 14 day period, consider potential false
positive and confer with infectious diseases specialists.

3. Suspect, probable and confirmed COVID-l9 patients who have clinically recovered and
are no longer symptomatic and have completed at least 14 days of isolation can be
discharged and tagged as recovered without RT-PCR or antibody testing, provided that
a licensed medical doctor clears the patient.

C. For Asymptomatic Patients

1. All asymptomatic non-health care workers who are close contacts of confirmed or
probable COVlD-l9 cases need to complete 14 days of quarantine from the date of
last contact with the confirmed or probable COVID-l9 case either at a temporary
treatment and monitoring facility or home quarantine if with a solo room with toilet.
Asymptomatic close contacts of confirmed or probable COVID-19 symptoms may be
tested using RT-PCR at the discretion of the contact tracing team and subject to the
availability of testing capacity. If symptoms develop at any time, prioritize collecting
samples for RT-PCR testing.
Patients can be released from quarantine after 14 days as long as the patient remains
asymptomatic for the entire duration of the quarantine, even without testing or test
results. There is no need to repeat RT-PCR testing prior to discharge and tagging as
recovered.

D. For Surveillance of Areas with Suspected COVID-19 Community Transmission

1. Expanded testing in areas with suspected COVID-l9 community transmission can be
performed at the household, purok, and barangay level with a proper sampling
methodology in collaboration with the Epidemiology Bureau, Centers for Health
Development and local health officials.
Properly validated antibody tests by RITM, DOST or FIND, can be used for this
purpose.

a. Pending availability of PRNT validation by RITM, all who intend to conduct

their own validation studies are requested to:
 i. register their studies through [email protected] (including update
on status of ethics approval)
ii. use the protocol for local validation study for asymptomatic contacts
provided (Annex C)
iii. report testing results (Annex A) through hrtucovidl9results(a}gmail.com
or through COVID CART (detectcovid.doh.gov.ph).

3. Testing of asymptomatic people should be performed with proper safety precautions,

including hand hygiene, use of appropriate PPEs for conducting the test, respiratory
hygiene, waste disposal, and patient care equipment.

4. All symptomatic patients should be referred for RT-PCR testing and isolated
accordingly.

IV. REPEALING CLAUSE

Department Memorandum 2020-0180 entitled “Guidelines on Expanded Testing for

COVID-l9,” Department Memorandum 2020-0229 entitled “Revised Criteria for Discharge
and Recovered for COVID-19 Cases,” and other related issuances inconsistent or contrary to
the provisions of this Memorandum are hereby repealed.

For strict compliance.

ISCO DUQUE III, MD, MSc

Secr ary of Health
Annex A. CASE TABULATION FORM

RT-PCR Outcome at the end of

D a te 0f IgM/IgG Date result 14 days from exposure
PhllHealth exposure
_

Brand of result .
(only if (asymptomatic,
. .

ID IgM/ symptomatic
to (+/-)
Test Kit IgG lgM+/[gG- non-COVID, COVID
Number known OR if confirmed asymptomatic,
(1 one
case developed COVID confirmed
IgM IgG symptoms) symptomatic)

l.
2.

3.

4.

5.

Data analysis
Positive and negative results will be tabulated and analyzed. Since there is no gold standard for
asymptomatic patients, serology results will not be used to confirm presence of absence of disease.
Only positive RT-PCR patients will be labeled as confirmed cases. Patients with isolated IgM but are
PCR negative and remain asymptomatic for 14 days will be considered false positives.
ANNEX B. USE OF RAPID ANTIBODY TESTS AS ADJUNCT TEST FOR TESTING
COVID-l9 AMONG SYMPTOMATIC PATIENTS WITH RELEVANT HISTORY OF
TRAVEL/EXPOSURE

Initial _
' or until
Action after 14:day quarantine .
Result Action
asymptomatic, whichever 15 longer
3M IgG
Repeat antibody test if RT-PCR is not
available.
Swab for RT-PCR
o If RT-PCR (+),
If IgM(-) & IgG(+), or IgM(+) & IgG(+), or
COVID-19 CASE.
Treat and isolate IgM(-) & IgG(-),
0 release from quarantine
accordingly.
0 If RT—PCR (-), not a
(-) (-) COVID-l9 case, but
If IgM(+)&IgG(-),
0 extend quarantine by seven-day
has to complete 14-day
increments and repeat testing
isolation. No need to
0 If persistently IgM positive but IgG
repeat antibody tests.
0 If RT-PCR not
negative for two consecutive retestings
after the lst 14 day period, consider
available, isolate for 14
potential false positives and confer with
days or until
infectious diseases specialists.
asymptomatic,
whichever is longer No need to repeat antibody test. Release from
(-) (+) quarantine.
Probable COVID-19 Repeat antibody test RT-PCR (-) or RT-PCR
Case: not available.
Swab for RT-PCR
o If RT-PCR (+), If IgM(-) & IgG(+), or IgM(+) & IgG(+), or
(+) (-) COVID-19 CASE. IgM(-) & IgG(-),
Treat and isolate 0 release from quarantine
accordingly.
0 If RT-PCR (-), not a If IgM(+)&IgG(-),
COVID—l9 case, but o extend quarantine by seven-day
has to complete 14—day increments and repeat testing
isolation. Repeat 0 If persistently IgM positive but IgG
antibody test. negative for two consecutive retestings
(+) (+) a If RT—PCR not after the lst 14 day period, consider
available, isolate for 14 potential false positives and confer with
days or until infectious diseases specialists.
asymptomatic,
whichever is longer
* Rapid antibody-based test is an adjunct test and shall not be used as a standalone test to
definitively diagnose or rule out CO VID—19
*The medical practitioner shall wear full personal protective equipment provided by the
health institution, when collecting specimens both for RT—PCR and rapid antibody test.
 ANNEX C. CLINICAL DIAGNOSTIC UTILITY OF AN IgM/IgG LATERAL FLOW
ASSAY IN COVID-19 FOR ASYMPTOMATIC CONTACTS

Introduction
COVID-l9 is a respiratory disease caused by the SARS-CoV-2 virus. As cases continue to increase in
the Philippines, scaling up testing has been challenging. The test of choice for COVID-l9 is
an RT-PCR
which requires a BSL2 facility, expensive equipment and materials, and highly trained personnel. The
turnaround time is typically 6 to 8 hours. Due to the current high demand for testing and limited
capacity, tests have been significantly delayed and cause major issues in hospital management of
suspected COVID—l9 patients. In the meantime, lateral flow assays have appeared on the market
purportedly to test IgM and IgG antibodies for quick diagnosis. Lateral flow assays can offer results in
as little as 15 minutes from a small sample of blood. However, lateral flow assays can be notoriously
inaccurate compared to ELISAs and other immunoglobulin-based tests. In addition, due to the short
incubation period of COVID-l9, the production of IgM is only starting at symptoms onset and will have
a significant risk of being falsely negative even in symptomatic individuals. This project will look at the
clinical utility of an approved COVID-l9 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test as an
adjunct diagnostic to RT-PCR in the diagnosis of COVID-19.
There is very little peer reviewed data on the utility of lateral flow assays for COVID-l9. A study by Li
and colleagues (2020) reported a sensitivity was 88.66% and specificity was 90.63% with a caveat that
the gold standard used was PCR. A study by Guo et a1. (2020) profiling early humoral response in
COVID-l9 using ELISA showed that combining IgM and RT—PCR results resulted in an increased
positive detection from 51.9% for PCR alone to 98.6% by combining both tests. An ELISA developed
by Duke/NUS has been validated using viral neutralization assays but results have not yet been
published in peer-reviewed literature
(https://www.gov.sg/article/how-a-breakthrough-lab-test-expert-contact-tracing-solved-mystery-behind-
largest-covid- l 9-cluster).

Objectives
1. Determine the distribution of results of an IgM/IgG lateral flow assay in asymptomatic patients
who are in close contact with known COVID—l9 patients.
2. Determine whether IgM positivity correlates to a positive RT-PCR in asymptomatic patients.
3. Determine whether IgM positive asymptomatic patients eventually develop symptoms
consistent with COVID-l9 within a 14-day period.

Methodology
Study design cross-sectional
:

Study population asymptomatic but with known close contact with a confirmed case in the last
:

5 days or more
Inclusion criteria: asymptomatic close contact
Exclusion criteria: symptomatic patients
Sample size computation: using the population of and an estimated 20% prevalence of
IgG, confidence level of 95% and a margin of error of 5%, the computed total sample size is at
least
Site of the study :

Study methodology :

o Asymptomatic patients with a history of close contact with a known COVID-l9 case will be
enrolled. Either a finger stick or venous whole blood from a laboratory draw will be used to
inoculate the IgM/IgG test kits for the cross-sectional study. If the patient develops anV
 COVID-l9 tVDe svmptoms for the duration of the study. he/she should be tested with an
RT-PCR regardless of IgM/IgG results.
0 The results of the IgM/IgG test will be reported according to the manufacturer’s
recommendations.
0 The results of the IgM/IgG test will be interpreted according to the following algorithm:

As‘, mptomahc i

Not an Acme Como-19 Case [

Close contacts ol knowr my: l No! a COVID Case

anly No need to isolate :

Presumptive Recmeed
COVID 19 Case
Presumptive COVID 19 Case
No need to iwlIll.‘

Presumptive CDVlD-19 Case

Isolate and do Nasal Swab {or

1: