the

Republic of 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

the and deaths in various territories, the World Health

With increasing number of cases
last March
Organization declared Coronavirus disease 2019 (COVID-l9) as a pandemic 11,
2020.

In to this the Task Force on Emerging Infectious

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

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

GENERAL GUIDELINES
II.

is defined as testing all individuals who are at-risk of

1. COVlD-19 Expanded Testing
(1) suspect
contracting COVID-19 infection. This includes the following groups: cases
and
or (2) individuals with relevant history of travel 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
San Lazaro Compound, Rizal Avenue. Sta. Cruz, 1003 Manila 0 Trunk Line 651-7800 local 1108, 1111, 1112, 1113
Building 1.
Direct Line: 711-9502; 711-9503 Fax: 743-1829 0 URL: http://wwwdohgovph; e-mail: ftduque@doh.gov.ph

2) Direct physical contact

confirmed
with a case
Direct
3) 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
the
reflects
sub-groups of
at-risk
individuals
in
arranged
order of
to
greatest
lowest need for
testing:

a. Subgroup A:
Patients or
healthcare
workers with
severe/critical
 symptoms, relevant history oftravel/contact

b. mild
Subgroup B: Patients or healthcare workers with 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: Patients or healthcare workers with mild

c. Subgroup symptoms, relevant history
oftravel/contact

d. D: Patients or healthcare workers with no

symptoms
Subgroup but relevant
history oftravel/contact

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

the
against COVlD-l9 which includes, but not limited to following: i. Personnel
the
manning Temporary Treatment and Quarantine Facilities (LGU- and
Nationally—managed);
ii. Personnel
manning Quarantine Control Points, including those from Armed
Forces ofthe Philippines, Bureau of Fire Protection, and others;
iii. iv.
National/Regional/Local Risk Reduction and Management Teams; Barangay
Health Teams and barangay officials
Emergency Response providing barangay
border control and performing COVID-l9-related tasks; v. Personnel of Bureau of
Jail
Corrections and Bureau of Penology and Management;
in the Management ofthe Returning
vi. Personnel manning the One-Stop-Shop
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. F. Other vulnerable patients such as those with comorbidities, those

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

i. ii.
Pregnant patients who shall be tested during the peripartum period; Dialysis
patients and patients who are immunocompromised, such as those who have
immune in
HIV/AIDS, inherited diseases that affect the system, those
chemotherapy or radiotherapy, who shall be tested at the discretion

of the attending
physician, following
 the for
existing guidelines of Philippine Society Microbiology and Infectious
Diseases.

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

the
However, in view of 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
the
testing capacity for health workers and remaining 70%-80% for patients.

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

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

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

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

and criteria for and confirmed COVID-19

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

the FDA and locally-validated by the

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

ll.
in
Disposal of test kits, including PPEs and other materials used testing, shall adhere
Care Waste
to the 4th Edition of Health Management Manual.

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

and
Results of such validation sero-epidemiological studies shall be submitted to
13.
Health
DOH, and to the Technology Assessment Council (HTAC) for their review and
fiiture
consideration. This should inform prospects of financing of DOH and
both agencies
PhilHealth since may only finance or reimburse COVID-19 test kits that
the
have been positively recommended by the HTAC as required by RA No. 11223 or
Universal Health Care Act.

III.
SPECIFIC
GUIDELINES

shall the
A. The following guidelines apply once FDA-approved antibody-based test kits have
the and
been locally-validated by the RITM or Department of Science Technology or
with %
those acceptable performance of >90% sensitivity and >95 specificity validated by
WHO-FIND:

1. doctors
Only licensed medical may request, administer, and interpret results ofrapid
professionals
antibody-based tests. Other licensed health may administer the rapid
antibody tests, provided that they wear appropriate PPEs and they are supervised by
be
licensed medical doctorThe medical doctor shall 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;
Case
c. filling online 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 DOH to be submitted to
the online form provided by
hrtucovidl9results@gmail.com (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
to
possible admission 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

that
Violation of RA 11332, which penalizes “non-cooperation of persons and entities
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
6
50,000 or imprisonment of not less than one month but not more than months, or
both such fine and imprisonment, and other applicable laws, rules and regulations.

B. For SymptomaticPatients

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

1. initial is
If the IgG
positive, the patient can
be released from
14
quarantine once days
is
completed or
asymptomatic,
is
whichever longer. If
is
the initial IgG
negative, repeat rapid
antibody-based testing
once asymptomatic or
14
after days, whichever
is
longer.

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

be released from quarantine.
patients can

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

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

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

RT—PCR is a confirmed COVID-l9 case and shall

If positive, the patient
be treated and undergo isolation accordingly.

RT—PCR
If negative, the patient has to complete the 14-day quarantine or
ii.
is and
until asymptomatic whichever longer repeat rapid antibody-based
test once asymptomatic.
1.
If results on repeat testing are IgG positive, regardless of IgM result,
be released from quarantine.
patients can

2. Ifresults on repeat testing

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

specialists.

RT-PCR
iii. If testing is not
available, isolate for 14 days
or once asymptomatic
whichever is longer. Repeat
rapid antibody-based testing
14
once asymptomatic or at
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.

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

3. have
Suspect, probable and confirmed COVID-l9patients who clinically recovered and
14 be
are no longer symptomatic and have completed at least days of isolation can
RT-PCR
discharged and tagged as recovered without or antibody testing, provided that a
licensed medical doctor clears the patient.

C. For AsymptomaticPatients

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

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

1. in be
Expanded testing areas with suspected COVID-l9 community transmission can
level with a
performed at the household, purok, and barangay proper sampling
in collaboration with the Epidemiology Bureau, Centers for Health
methodology
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
covid19rdt@gmail.com
(including update on
ethics
status of
approval)
ii.
use the protocol
validation
for local
for
study
asymptomatic
contacts provided
(Annex C)
iii.
report testing results
(Annex A) through

CART
hrtucovidl9results(a}gmail.com or through COVID
(detectcovid.doh.gov.ph).

3. with
Testing of asymptomatic people should be performed proper safety precautions,
 PPEs for the
including hand hygiene, use of appropriate conducting test, respiratory
and
hygiene, waste disposal, patient care equipment.

All RT-PCR
4. symptomatic patients should be referred for 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
inconsistent the
Recovered for COVID-19 Cases,” and other related issuances or contrary to
provisions ofthis 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

Dt f
ae0

14 from exposure exposure

IgM/IgG Date result days PhllHealth result . Brand . . of IgM/ (only if
(asymptomatic, symptomatic
_

ID to (+/-) lgM+/[gG- non-COVID, COVID

Test Kit IgG Number known(1OR if confirmed asymptomatic,
COVID
caseone developed confirmed
symptoms) symptomatic)
IgM IgG

l.
2.

3.

4.

5.

Data analysis
is
Positive and negative results will be tabulated and analyzed. Since there no gold standard for
confirm
asymptomatic patients, serology results will not be used to presence of absence of disease.
RT-PCR
Only positive patients will be labeled as confirmed cases. Patients with isolated IgM but are PCR
and remain 14 false
negative asymptomatic for days will be considered 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_' . Result Action Action after 14:day quarantine or until IgG 3M

15
asymptomatic,whichever longer Repeat antibody test if RT-PCR is not

(+) (+)
Swab for RT-PCR
(-) (-) o If RT-PCR (+),
COVID-19 CASE.
(-) (+) (+) (-) Treat and isolate
accordingly.
RT—PCR
0 If (-), not a
COVID-l9 case, but has to
complete 14-day isolation. No 0
need to repeat antibody tests. 0
If RT-PCR not
available, isolate for 14 days
or until
asymptomatic,
is
whichever longer

Probable COVID-19 Case:

Swab for RT-PCR
RT-PCR
o If (+),
COVID-19 CASE.
Treat and isolate
accordingly.
0 If RT-PCR (-), not a
COVID—l9
case, but has to
complete 14—day isolation.
Repeat
antibody test.
a If RT—PCRnot
available, isolate for 14 days

or until
asymptomatic,
is
whichever longer

available. If persistently IgM positive

but IgG negative for two
&
If IgM(-) IgG(+), or IgM(+)consecutive retestings after the
14
& & lst day period, consider
IgG(+), or IgM(-) IgG(-),
false
0 release from quarantine potential positives and
confer with infectious
If IgM(+)&IgG(-), diseases specialists.
0 extend quarantine by
to
seven-day No need repeat antibody
and
increments repeat testing test. Release from quarantine.
 & &
Repeat antibody test IgG(+), or IgM(-) IgG(-), 0 If persistently IgM positive
0 release from quarantine
but IgG negative for two
RT-PCR
RT-PCR(-) or not consecutive retestings after
available. 14
If IgM(+)&IgG(-), the lst day period, consider
o extend quarantine by potential false positives and
&
If IgM(-) IgG(+), or IgM(+)seven-day confer with infectious
and
increments repeat testing diseases specialists.

* is
Rapid antibody-based test an adjunct test and shall not be used as a standalone test to
rule out CO VID—19
definitively diagnose or
medical
*The practitioner shall wear full personal protective equipment provided by the
when both and
health institution, collecting specimens for RT—PCR rapid antibody test.
 AN
ANNEX C. CLINICAL DIAGNOSTIC UTILITY OF IgM/IgG LATERAL FLOW
ASSAY IN COVID-19 FOR ASYMPTOMATIC CONTACTS
Introduction
is As the
COVID-l9 respiratory disease caused by the SARS-CoV-2 virus. cases continue to increase in
a
scaling been is which
Philippines, up testing has challenging. The test of choice for COVID-l9 an RT-PCR
trained
requires a BSL2 facility, expensive equipment and materials, and highly personnel. The
is 6 to 8 hours. Due to the
turnaround time typically current high demand for testing and limited capacity,
been and in
tests have significantly delayed cause major issues hospital management of suspected
COVID—l9 the flow have
patients. In meantime, lateral assays appeared on the market purportedly to test
flow little 15 minutes
IgM and IgG antibodies for quick diagnosis. Lateral assays can offer results in as as
from a small sample of blood. However, lateral flow be inaccurate
assays can notoriously compared to
incubation
ELISAs and other immunoglobulin-based tests. In addition, due to the short period of
the is at
COVID-l9, production ofIgM
symptoms onset and will have a significant risk of
only starting
in clinical
being falsely negative even symptomatic individuals. This project will look at the utility of an
COVID-l9
approved IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test as an adjunct diagnostic to
the
RT-PCR in diagnosis of COVID-19.

is little the flow A

There very peer reviewed data on utility of lateral assays for COVID-l9. study by Li
and colleagues (2020) reported a sensitivity was 88.66% and specificity was 90.63% with a caveat that
used PCR. A study by Guo et a1. humoral in
the gold standard was (2020) profiling early response
COVID-l9 showed that in
using ELISA combining IgM and RT—PCR results resulted an increased
positive detection from 51.9% for PCR alone to 98.6% by combining both tests. An ELISA developed
neutralization
by Duke/NUS has been validated using viral assays but results have not yet been
in
published peer-reviewed literature

(https://www.gov.sg/article/how-a-breakthrough-lab-test-expert-contact-tracing-solved-mystery-behind
l
largest-covid- 9-cluster).

Objectives

1. flow in
Determine the distribution of results of an IgM/IgG lateral assay asymptomatic patients
COVID—l9
who are in close contact with known patients.
RT-PCR in
2. Determine
whether IgM positivity correlates to a positive 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 :

in the last 5
Study population asymptomatic but with known close contact with a confirmed case
:

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,
size is at
confidence level of 95% and a margin of error of 5%, the computed total sample least
the
Site of study :

Study methodology :
 will be
o Asymptomatic patients with a history of close contact with a known COVID-l9 case
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
RT-PCR
an
regardless
of
IgM/IgG
results.
0 The
results of
the
IgM/IgG
be
test will
reported
according
to the
 manufacturer’s recommendations.
the the
0 The results of IgM/IgG test will be interpreted according to following algorithm:

As‘,
mptomahc i

Not an Acme Como-19 Case [

Close knowr No need to isolate

contacts ol my: l
No! a COVIDCase anly :

PresumptiveRecmeed
Case
COVID 19 Presumptive COVID 19 Case
Ill.‘
No need to iwl

Presumptive CDVlD-19 Case

1:
Isolate and do Nasal Swab {or