Professional Documents
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CDC: Procedures that concentrate 3. Place the second container into the outer
viruses, such as precipitation or container e.g., ice box. Ensure that the
membrane filtration, can be performed in required temp is maintained in the outer
a BSL-2 laboratory with unidirectional container through the use of wet ice or
airflow and BSL-3 precautions, including refrigerant packs
respiratory protection and a designated
area for donning and doffing PPE. The
donning and doffing space should not be
in the workspace. Work should be GENERAL GUIDELINES FOR ALL BIOLOGICAL
performed in a certified Class II BSC. SPILLS
B. PERSONAL PROTECTIVE EQUIPMENT Report all spills to the immediate
When collecting respiratory tract supervisor. Seek immediate medical
specimens, healthcare workers should attention (if needed).
wear the following PPE: Face Perform hand hygiene before and after
shield/visor , surgical mask, double clean-up.
gloves, a disposable impermeable, Don appropriate PPE before clean-up.
breathable, long-sleeved, laboratory Use a freshly prepared 1:10 dilution of
gown fastened at the back. If the Sodium Hypochlorite (household bleach);
specimen is collected with an aerosol- allow at least 20-30 minutes contact
generating procedure, staff should wear a time. (viscous spills: 15-20 mins, non-
particulate respirator at least as viscous: at least 30 mins)
protective as a NIOSH-certified N95, an Buddy system must be observed during
EU standard FFP2, or the equivalent. biological spill response.
C. SPECIMEN STORAGE Prepare a written report about the
Swabs should be placed immediately into incident and conduct incident
a sterile transport tube containing 2-3mL investigation.
of either viral transport medium (VTM), Dispose-off clean-up materials along with
Amies transport medium or sterile saline. any contaminated PPE as biohazard
Label the vial with the patient’s name, waste and place in a biohazard bag
specimen type, date collected and other before autoclaving.
required information. Prepare a written report about the
Both swabs (NPS&OPS) can be placed in incident and conduct incident
the same vial, to maximize test investigation.
sensitivity, increase the viral load and INTERIM GUIDELINES ON EXPANDED TESTING
limit use of testing resources. (DOH MEMO 2020-0151, March 31, 2020)
If specimens will be examined within 48 For Symptomatic Non-Health Care Workers
hours after collection, keep specimens at 1. Testing of symptomatic patients who are
4 C and ship on wet ice or refrigerant gel-
o
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II. If RT-PCR positive, the patient is a 2. Nucleocapsid phosphoprotein (N)
confirmed COVID-19 case and shall be Most abundantly expressed
treated and undergo isolation accordingly. immunodominant protein that interacts
III. If RT-PCR testing is not available, isolate with RNA
the patient for 14 days. Repeat rapid The protein target determines cross-
antibody-based testing once asymptomatic, reactivity and specificity because N is
and follow protocols for asymptomatic more conserved across coronaviruses
patients. than S, and within S, RBD is more
B. If IgM positive, the patient is a probable conserved than S1 or full-length S.
COVID-19 case. Collect swab for RT-PCR
testing.
I. If RT-PCR positive, the patient is a TYPES OF ANTIBODY TESTING
confirmed COVID-19 case and shall be 1. BINDING ANTIBODY DETECTION
treated and undergo isolation These tests use purified proteins of SARS-
accordingly. CoV-2, not live virus, and can be
II. If RT-PCR negative, the patient has to performed in lower biosafety level
complete the 14 day home quarantine laboratories (e.g., BSL-2).
and repeat rapid antibody-based test. a. Point-of-care (POC) tests
III. If RT-PCR testing is not available, isolate Generally are lateral flow devices that
for 14 days. Repeat rapid antibody-based detect IgG, IgG and IgM, or total antibody
testing once asymptomatic, and follow in serum, plasma, whole blood, and/or
protocols indicated for asymptomatic saliva. An advantage of some point-of-
patients. care tests using whole blood is that they
For Asymptomatic Non-Health Care Workers : can be performed on blood samples
Rapid antibody testing may be used for obtained by fingerstick rather than
asymptomatic non-health care workers, venipuncture.
particularly for close contacts of confirmed COVID- b. Laboratory tests use ELISA (enzyme-linked
19 cases. immunosorbent assay) or CIA
1. If the patient tests negative for both IgM (chemiluminescent immunoassay) methods
and IgG,there is no need to isolate, unless for antibody detection, which for some
the patient becomes symptomatic. assays may require trained laboratorians and
However, they shall strictly observe the specialized instruments. Based on the
quarantine procedures in their locality. reagents, IgG, IgM, and IgA can be detected
2. If the patient tests positive IgG only, the separately or combined as total antibodies.
patient is considered a presumed 2. Neutralization Tests - not yet authorized
recovered case, and there is no need to by FDA
isolate. However, they shall strictly Surrogate virus neutralization tests
observe the quarantine procedures in (sVNT) have also been developed. These
their locality. are binding antibody tests designed to
3. Patients who test IgM positive shall be detect potential neutralizing antibodies,
isolated at home or at a community often those that prevent interaction of
quarantine facility for 14 days. If they RBD with angiotensin-converting enzyme
become symptomatic, they will be 2 (ACE2, the cell surface receptor for
treated as probable COVID-19 cases and SARS-CoV-2).
shall follow the protocol indicated. a. Virus neutralization tests (VNT), such as the
ANTIBODY TESTING INTERIM GUIDELINES (CDC, plaque-reduction neutralization test (PRNT)
August 1, 2020) and microneutralization, use a SARS-CoV-2
ANTIGENIC TARGETS virus from a clinical isolate or recombinant
1. Spike glycoprotein (S) SARS-CoV-2 expressing reporter proteins.
Essential for virus entry and is present on This testing requires BSL-3 laboratories and
the viral surface may take up to 5 days to complete.
Multiple forms of S protein-full-length b. Pseudovirus neutralization tests (pVNT) use
(S1+S2) or partial (S1 domain or receptor recombinant pseudoviruses (like vesicular
binding domain [RBD])—are used as stomatitis virus, VSV) that incorporate the S
antigens. protein of SARS-CoV-2. This testing can be
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performed in BSL-2 laboratories depending
on the VSV strain used.
Serologic testing by itself should not be
used to establish the presence or
absence of SARS-CoV-2 infection or
reinfection.
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