POSITION PAPER

PHILIPPINE SOCIETY OF PATHOLOGISTS, INC.

Diagnostic Testing Strategies to Manage COVID-19 Pandemic

Proposed by the Philippine Society of Pathologists, Inc.

The Philippine Society of Pathologists, Inc. (PSP) is We propose an expanded targeted testing for screening
an organization of physicians specializing in Pathology asymptomatic populations to be conducted in the
and Laboratory Medicine. It is one of the eight following situations:
recognized specialty members of the Philippine Medical A. High prevalence communities for epidemiologic
Association. It has a membership of over 1,000, whose surveillance and aggressive contact tracing
specialization and sub-specializations are in various areas B. Health care workers with low risk exposure
including Molecular Pathology and Immunopathology. C. Workplace testing
It stands in solidarity with the rest of the nation in its D. Border testing at airports and seaports for inbound
fight against SARS-COV-2. foreign travelers and returning residents
E. Overseas deployment of OFWs
To date, the country has not gained inroads in producing F. Returning OFWs
significant number of SARS- COV-2 PCR testing. In over G. Frontline government workers (police, military,
3 months only 307,813 of cumulative tests, 283,147 tests quarantine, immigration officers to name a few)
of cumulative unique individuals have been deployed (doh.
gov.ph/covid19tracker, May 25, 2020). This only represents Predictably, this will entail millions of PCR tests to be
less than 1% of over 110 million population who have conducted. In a resource-poor environment, this is
been tested in the Philippines. A 7.6 % incidence has been not practical. In addition, countries all over the world
established from a total of 21,643 positive cases identified, are suffering from the unavailability and shortage of
out the 283,147 unique samples tested. Country incidence diagnostic tests and supplies as cases continue to rise.
rates and prevalence studies have not yet been established.
The disparity between the required number of reagent kits
The RT-PCR which is the gold standard for SARS-COV-2 and the actual number needed to be tested has impeded
testing is a laborious procedure requiring high levels efforts of DOH to identify and isolate infected individuals.
of sophisticated equipment, engineering and biosafety In most cases, testing is restricted mainly towards
standards, controls, and personnel proficiency. The symptomatic cases, with the vast number of asymptomatic
molecular testing technology is expensive and is not cases going undetected.
readily available in the country, although there is now a
widely concerted effort to establish molecular pathology In order to achieve a significant and expanded number
laboratories nationwide. of target populations to be tested, there must be a
comprehensive and cost-effective strategy in place.
To flatten the COVID-19 curve, the PSP is proposing the The Philippine Society of Pathologists, Inc. proposes
formulation of an expanded targeted testing strategy. the following:
This will enlarge the population base of persons to be
tested in the country in order to identify and survey the I. THE USE OF MOLECULAR BASED PCR TESTING
asymptomatic carriers who shed the SARS-COV-2 virus
and unknowingly infect the community. A. “Smart Pooled Sample Testing”
This procedure will help meet the high demand of testing
The proposed expanded targeted testing strategy will not SARS-COV-2 in the early identification and isolation of
test all of the 110 million Filipinos, but rather escalate the asymptomatic individuals. The pooling of samples before
testing population base to the Asymptomatic Population nucleic acid testing is a safe and well-established procedure
who are at risk and those communities with high prevalence. in blood banking. We recommend using this as well,
in expanded and targeted screening for SARS-COV-2.
For this purpose, expanded targeted testing will be defined
as an enhanced, wider based purposive testing, designed We propose two algorithms in the conduct of pooled
to test a greater number of asymptomatic populations testing of asymptomatic individuals during expanded
at risk, based on robust scientific and epidemiologic data. targeted testing using:

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Diagnostic Testing Strategies to Manage COVID-19 Pandemic Philippine Journal of Pathology | 6

Algorithm A. Algorithm for PCR pooled testing in asymptomatic individuals.

*Size of pools and subpools will depend on the prevalence of COVID-19 in the target population.

A1. Pooled nasopharyngeal / oropharyngeal samples pooled samples. The higher the prevalence, the lower
for direct RT-PCR testing (Algorithm A)” the recommended sample pool.
*Samples from several individuals are collected and uniquely
identified from nasopharyngeal or oropharyngeal swabs. The In our setting, we recommend a pooled sample range
samples are then pooled and tested together in a single tube of 5-30 based on the risk, prevalence and suspected
using standard RT-PCR method. If a POSITIVE result is incidence. In case one of these 5-30 pooled samples
achieved from a pooled sample, this will be tested individually. turn out to be positive, same will be subjected to sub-
If a negative pooled sample is achieved, all the samples are pooling containing lower number of samples for PCR.
issued a NEGATIVE result. The pooled sample that will turn out to be positive, will
then be individually tested by PCR. This method would
The number within the pooled sample would have to need to be scientifically validated by our COVID-19
be guided and determined by robust statistical and PCR testing laboratories.
epidemiologic data. When the infection rate in a given
population is low and only a few people are infected, pool This strategy will considerably reduce the workload and
testing can significantly expand the testing capacity of conserve the much- needed PCR resources in the country
the existing laboratory infrastructure. (approximately 60-80% reduction); provide a more cost-
effective method of testing and ramp up the number
In other countries (Pakistan, India, Israel, some EU of populations to be screened for appropriate contact
countries), the pooled sample number ranged from 5-63 tracing and surveillance.

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Algorithm B. Algorithm for identifying COVID-19 cases using combined serological and pooled polymerase chain reaction testing.
*The size of the initial pooled samples are best determined by the PCR laboratory based on available epidemiological data and the
succeeding sub-pooling of individuals can be based on the size of the initial pooled sample. Sub-pooling may also be skipped if the
initial pool size is small (e.g. 5 or less).

A2. Initial antibody testing using instrumented We recommend the use of instrumented method of
laboratory-based methods like ELISA and ECLIA. antibody testing for reasons of increased throughput that
(Algorithm B) is required in expanded testing, coupled with higher
The rationale of the algorithm using instrumented antibody analytical performance (better accuracy, sensitivity,
testing (Algorithm B) is that laboratory-based antibody tests specificity and lower limits of detection).
are already available in the market. The instrumentation for
such tests is already in place in many hospital laboratories, thus The use of Rapid Antibody Test kits is NOT recommended
eliminating the need for capacity building, both in equipment because of poor sensitivity and specificity, leading to
and personnel. This is much faster and cheaper than molecular higher false negatives and false positive which will
methods for screening purposes but will not replace it, rather ramp up for the need of PCR testing.
they are meant to conserve and supplement molecular assays.
B. Ensuring efficient proactive supply chain
The laboratory based instrumented assays are superior to management of PCR test kits/supplies and
rapid antibody tests as they have undergone more scrutiny and streamlining operations in COVID-19 testing
validation, both internal and external before their introduction.
B1. Putting up a dedicated agency within DOH
We recommend the pooling method for RT-PCR assays to which will efficiently provide the following
reduce the volume of testing and facilitate clearance of low functions:
risk individuals. Negative serological tests will be subjected to • Central management and tracking of
pooled samples for PCR. inventories of reagents and supplies to
ensure adequacy and availability;
High risk individuals (symptomatic, frontline health • Repository of information on the source,
care workers and those with history of exposure) should origin, updated prices of reagent and
be tested individually. The pooling method will greatly supplies for end users. The PSP can assist
reduce the limited resources, workload of the RT-PCR DOH in the securing of this information.
laboratories and reduce work-related injuries and illnesses
due to fatigue.

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C. Streamlining operations in COVID-19 testing. B. There are differences in analytical performance

of different serologic methods. The prudent
C1. Reduce the documentation requirements use of these should be based on performance
to be sent to various DOH agencies that do characteristics of the different analytical methods
not add value to the testing process and in order to reduce incidence of false negatives
increases the length of the turn-around-time, and false positives.
e.g. reporting for negative data, sub-national
laboratories submission of daily work sheets C. We recommend the use of instrumented assays
to RITM. for Antibody testing using ELISA and ECLIA on the
C2. Review the reporting protocol for COVID-19 following basis:
testing to reduce unnecessary documentation. • Higher throughput and turn-around-time,
desirable in an expanded testing program
D. Simplify licensing requirements for COVID -19 • Earlier detection of antibody levels in patients
testing laboratories who are exposed
• Excellent analytical specificity and sensitivity
D1. To comply with the training requirements for • Lower detection limit which allows to identify
COVID-19 testing, the PSP is willing to assist population with low antibody titers
DOH/RITM by conducting recognized training • Less interferences and cross-reactivities
modules in Molecular Pathology and Biosafety/ • Use of quantitative immunoassays and will allow
Biosecurity procedures for pathologists, for detection of neutralizing antibodies
medical technologists and other relevant
health care workers. D. Based on the Clinical laboratory Law (RA No. 4688,
D2. Review and harmonize the licensing June18, 1966) and AO 2007- 0027, laboratory tests
requirements of Rapid PCR testing that are not must be performed and supervised by a Clinical
appropriate for the technology, like facility Pathologist and results are issued by a licensed
site, equipment, training and personnel. clinical laboratory. This is to ensure quality of test
results and to assure the protection and safety
E. Use of Rapid PCR testing like GeneXpert technology of both personnel and environment.

E.1 Ensure that the donated GXP cartridges In summary, we, the Pathologists stand ready to be in
be deployed in hospital settings which the forefront of diagnostic testing during this pandemic.
require immediate results for management We propose expanded targeted testing algorithms
and decision making, e.g. critical care, combining molecular virus detection and laboratory-based
pre-operative requirements and medical antibody assays in an effort to reduce transmission of
emergencies. SARS-COV-2 in the Filipino population. We will win this
E.2. The donated cartridges should be deployed to battle and together we can heal as one.
the hospitals to allow immediate access and
service delivery. For the Philippine Society of Pathologists, Inc:

II. THE EFFECTIVE, EFFICIENT UTILIZATION OF

ANTIBODY TESTING

A. Antibody testing has a role in COVID-19

management. It is cost-effective strategy for the
following situations:
• Workplace and conditions for return to work ROBERTO D. PADUA JR., MD, FPSP
• Epidemiologic surveillance for prevalence and President
population immunity
• Research May 29, 2020

https://doi.org/10.21141/PJP.2020.08

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