Molecular Testing


COVID-19 tests are critical to measuring the spread of the disease and determining how to handle the pandemic. The two prevailing COVID-19 test types – serology tests and viral tests – serve different purposes and have different limitations. Knowing the following facts about these tests will help you decide which test is tailor-fit to your needs.

Viral Test

What is the test?

A viral test is an oral or nasal swab or saliva test that looks for evidence of an active viral infection. There are two major types: a PCR test and an antigen test.

What does the test do?

PCR tests look for the presence of a virus’s genetic material, while antigen tests look for specific proteins on a virus’s surface. Antigen tests produce results more quickly, but may be less sensitive.

What doesn’t the test do?

Viral tests do not indicate whether someone was infected in the past.

How does the FDA handle the test?

The FDA formally evaluates these tests prior to use.

Serology Test

What is the test?

A serology test is a blood test that looks for evidence of someone’s prior infection with the virus.

What does the test do?

The test provides evidence thatsomeone may have been exposed to the virus in the past, potentially even if they did not have symptoms, by detecting antibodies specific to the virus.

What doesn’t the test do?

The test does not diagnose an active infection or identify who is protected from reinfection (antibodies have not been proven to guarantee immunity).

How does the FDA handle the test?

The FDA does not formally evaluate these tests prior to use, though a few have Emergency Use Authorization.

FAQ's

Have questions? Looking to book with us or learn more about our services? Check out some of our FAQs below.

Anyone with symptoms should be tested, wherever possible. People who do not have symptoms but have had close contact with someone who is, or may be, infected may also consider testing – contact your local health guidelines and follow their guidance.

While a person is waiting for test results, they should remain isolated from others. Where testing capacity is limited, tests should first be done for those at higher risk of infection, such as health workers, and those at higher risk of severe illness such as older people, especially those living in seniors’ residences or long-term care facilities.
It is recommended to get tested after 5-7 days from date of exposure to a known COVID-19 positive individual.

The incubation period of COVID-19, which is the time between exposure to the virus and symptom onset, is on average 5-7 days, but can be as long as 14 days.
Php 3,409.00 per test.
We offer 24-48 hours and 6-12 hours turnaround time.
Yes, contact us directly for more information.
Yes, contact us directly for more information.
When it comes to COVID-19 testing, your choice of test type usually is a choice between accuracy and speed. You need to fully understand the tools available in the toolkit, and then pull out the right one at the right time.

A COVID-19 antigen test can provide results quickly, but RT-qPCR is considered the gold standard for COVID-19 testing as it provides a more definitive answer as to whether an individual has the virus in their body. In fact, in situations where antigen testing is used for rapid screening, negative results are often sent to the lab for confirmatory RT-qPCR testing to verify if the individual is indeed virus-free. In addition, there is a third type of test: a COVID-19 antibody test. An antibody test is a blood test that does not detect active virus. Instead, it detects antibodies to SARS-CoV-2. The presence of antibodies indicates that someone is actively dealing with, or recovered from, a COVID-19 infection.
BioPATH uses US/Europe brands, FDA approved, and RITM validated test kits:

PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay
https://perkinelmer-appliedgenomics.com/home/products/sars-cov-2-real-time-rt-pcr-assay-ce-ivd/
Xpert Xpress SARS-CoV-2
https://www.cepheid.com/coronavirus
A positive or negative result is affected by several factors such as viral load, course (day), of the disease, patient immune response, medications and presence of PCR inhibitors, swabbing technique and sample quality.

“It is expected that a series of positive results could be immediately followed by a negative result within a few days, which is the normal course of the disease as the body attempts to recover and eliminate the virus.”
Our tests detect 3 types of genes found in COVID-19 virus. ORF1ab, N2, and E. When a presumptive positive result is released, only E gene is detected. E gene is may also be detected in other types of virus.

Recently, manufacturer (Cepheid) of our test kits recently released a statement:

“Presumptive Positive results in the GeneXpert SARS-CoV-2 assay should be interpreted by the laboratory according to existing national or local laws and guidelines. If other RT-PCR assays with different target genes (other than N2) are available, it can be retested to confirm the result. However, other countries consider the Presumptive Positive result of the GeneXpert, where the E target is positive but the N2 target is negative due to a mutation in the N2 sequence, as True Positive result based on sequence analysis and positive results in other diagnostic platform.”

As such, results from Xpert Xpress SARS-CoV-2 Assay should only be reported as POSITIVE or NEGATIVE following the above guidelines.
When one of the two targets, but not both, is present above the threshold for positivity, the test is reported as “inconclusive”. This is usually seen with low amounts of viral DNA. In practice, “inconclusive” results should be treated as presumptive positive COVID cases with a low viral load present.
Sometimes a test sample may not give a clear result. This is called an indeterminate/invalid/inhibitory result. This means sample provided is not optimal and cannot produce appropriate data to determine if individual tested is infected or not. Recollection of sample is required.

About Proactive Testing

The global fight against COVID-19 is getting a boost from improvements in the diagnostic testing field, with several tests designed to diagnose patients who currently have active viral infections. Diagnostics that can detect active infections are typically molecular-based, which help researchers detect the presence of the pathogen, through the identification of its genetic material or the unique markers of the pathogen itself. According to John Hopkins Center for Health Security, the viral genomic material for SARS-CoV-2 is ribonucleic acid (RNA), which remains in the body only while the virus is still replicating. In contrast, other tests identify COVID-19 mid-infection as the virus multiplies (antigen test), while another type -- the serology test -- identifies IgG antibodies, proteins produced by the body in late stages of infection.

While these tests serve specific needs that differ from organization to organization, molecular testing for COVID-19 is currently the gold standard in terms of reliability and detection. It has been valuable in determining who has the active infection and how to help stop the virus from spreading -- key information that will help the country's fight against the virus.

As one of the pioneering laboratories offering molecular diagnostics in the Philippines for 16 years, we at BioPATH believe that this is not something you learn overnight, or in the course of a few months. We have spent years upon years developing our lab team's expertise, in order to serve our customers best.

GeneXPERT®

For random access and near-patient care testing with rapid turnaround time results, BioPATH Clinical Diagnostics uses the GeneXpert. Results are available within 6 hours of receiving a sample. Due to the limited supply of Xpert cartridges, we provide the GeneXpert test on a priority basis and only for patients who need it most, per doctor’s request.

Cepheid has developed an automated molecular test for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19. The test leverages the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted. The test can provide rapid detection of the current coronavirus SARS-CoV-2 in as soon as 30 minutes for positive results^ with less than a minute of hands-on time to prepare the sample.

Standard RT-PCR Test with
Perkin Elmer

For traditional testing, our laboratory is equipped with fully automated Perkin Elmer Pre-NAT extraction and Thermo Fisher Quant Studio-5 real-time machines capable of doing no less than 1,000 tests per day. Results are released within 24-48 hours of receiving a patient’s sample swab.

The PerkinElmer® SARS-CoV-2 Real-time RT-PCR assay is CE-IVD marked and intended for in vitro diagnostic use. This assay provides reliable and high-quality results for the clinical detection of COVID-19 in human oropharyngeal swab, nasopharyngeal swab, bronchoalveolar lavage (BAL), sputum, plasma or serum samples.

Read More About COVID-19

SARS-CoV-2 or Severe Acute Respiratory Syndrome Coronavirus 2 is the virus that causes the coronavirus disease, or COVID-19. Viruses and the diseases they cause often have different names. People often know the name of a disease, but not the name of the virus that causes it.

Read more

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