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Aculabs has aggressively worked with both state authorities and our industry peers to tackle the unique ways COVID-19 has impacted post-acute care and the wellness of the residents who our clients serve daily. Our laboratory understands and believes that such urgency is demanded given that the residents of long term care homes and assisted living facilities are considered high-risk under the criteria put forth by the Centers for Disease Control and Prevention (CDC).

The Aculabs – COVID-19 Information Hub is an online source meant to assist current and potential clients in assessing the testing needs of their facility’s residents and remain up-to-date with information regarding ongoing state-level regulations and compliance standards. We ask that clients continually check for new updates as they continue to develop.

Aculabs will also accept the following swabs for #3994 SARS-CoV-2 RT-PCR molecular testing::

  • Viral Transport Media: BD® Universal Viral Transport (UVT), Copan® (UTM), Hardy Diagnostics Healthlink UTM, Puritan® UniTranz Media, Starplex™ Scientific Multitrans, and Thermofisher® M4/M5/M6
  • ESwab™: BD, Copan

SARS-CoV-2 antibody testing is done via a blood draw that is collected in a serum-separating tube (SST) by our mobile technicians. We also ask that all facilities’ nursing staff do not freeze any swabs. Swabs that will not be collected and picked up the same day may be refrigerated, but respiratory swabs should never be frozen.

Aculabs also may recommend client facilities preserve other types of transport media for testing unrelated to COVID-19. Please see the below specimen collection guides for more info:

04/13/21CDC – Collect Your Anterior Nasal Swab Sample for COVID-19 Testing
10/01/20HealthPulse – Lower Nasal Swab Self-Collection Animation
05/04/20Aculabs – Respiratory Specimen Collection – Specimen Bagging Instruction Guide

  • INCORRECT SWAB* – Aculabs provides clients with swabs for COVID-19 testing that are appropriate for the testing we perform and laboratory equipment used. Sometimes, facilities may take it upon themselves to acquire swabs from outside sources. We ask facilities to not use swabs with calcium alginate tips, preservatives, or wooden shafts.
  • NOT LABELED*† – Our Accessioning team works to ensure all specimens are appropriately identified and matched to coordinating test requisitions forms. Due to the influx of testing, though, we must ask all nursing staff to help reduce the chance of error and ensure all specimens and specimen bags are appropriately labeled with patient information.
  • SENT ON ICE* – We ask all client facilities to not send COVID-19 specimens on ice, with ice packs, or with anything that can melt. Ice that melts makes it difficult to discern melted ice from a specimen that has leaked.
  • SPECIMEN LEAKED* – Aculabs must ask all nursing staff to ensure caps to COVID-19 specimen are secured tightly to prevent the transport media from opening and leaking. Leaked specimen often are no longer sufficient to run and pose a potential danger to laboratory staff.

* – RT-PCR Testing  |  † – Antibody Testing

Employee Testing and Payment

Long term care facilities who desire to have COVID-19 testing ran on their staff by Aculabs must accept full financial responsibility for the cost of all employee testing requested. To ensure completion of payment, Aculabs may require a facility to present a credit card to be kept on file. Facilities using Aculabs’ diagnostic services for COVID-19 testing are encouraged to use our Pay Bill portal to make payment easier and more convenient.

To order testing for your employees, you must contact your customer service representative for your employee account log-in information to our online web portal. Such ordering structure is done so in order to protect confidentially of those tested in accordance with HIPAA. Our Billing Department must ask all client facilities ordering employee testing to ensure they select the “Employee” unit and “Facility” as the ‘bill to’ type.

Reimbursement and ICD-10 Codes

The following codes are acceptable diagnoses for reimbursement for COVID-19 testing: J12.89, J20.8, J22, J40, J80, J98.8, Z03.818, Z20.828. The most commonly used codes are R05, R06.02, R50.9, B34.2. The code B97.29 can only be used in conjunction with the first 6 diagnoses listed. All COVID-19 test orders require a proper diagnosis in order to be processed and run.

Facilities wishing to acquire COVID-19 testing services from Aculabs should reach out to our Customer Service team. In accordance with Section 3202(b) of the CARES Act, Aculabs makes the cash price of all COVID-19 diagnostic testing offered publicly available. Pricing for COVID-19 testing can be found in the table below:

Test: SARS-CoV-2 Molecular TestingPrice: $60.00
Test: Anti-SARS-CoV-2 Total Antibody TestPrice: $50.00
Test: SARS-CoV-2 IgG AssayPrice: $65.00
Test: SARS-CoV-2 IgM AssayPrice: $65.00

11/23/20 Update – In conjunction with a launch by the New Jersey Department of Health of a pilot program for the BinaxNOW CoV-2 Antigen test cards, the NJ DoH has also clarified that, in addition to facility staff, vendors going into long-term facilities will also be able to use a previously received negative result as long as it is no older than 48 hours to gain entry.

This means that phlebotomists who are swabbed at their first routine facility may use a negative result to then gain entry without consecutive testing throughout the day. Aculabs technicians will keep a record of their negative results on their employee work phones.

All Aculabs employees have been trained to follow our Standard Operating Procedures and Infection Control Plan, which outlines in detail the appropriate measures to take when handling any potentially infectious specimen. Additionally, all employees who experience direct patient contact must follow protocol to wear all necessary personal protective equipment (PPE) to reduce the risk of exposure to and transmitting COVID-19.

03/24/20Precautions & Protocols to Reduce Exposure to COVID-19 for all Aculabs Employees
05/29/20Update on Testing Aculab Employees for all New Jersey-located Client Facilities

Aculabs offers SARS-CoV-2 RT-PCR testing – molecular testing meant to aid in the diagnosis of an active infection of SARS-CoV-2, the virus which causes COVID-19. Aculabs currently uses multiple methods of instrumentation including the BioGX SARS-CoV-2 Reagents for BD MAX™ System, a real-time RT-PCR intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples.

All tests are authorized for use by the U.S. Food and Drug Administration (FDA) via an emergency use authorization (EUA).

04/08/20BioGX SARS-CoV-2 Reagents for BD MAX™ System – Fact Sheet for Patients
04/08/20BioGX SARS-CoV-2 Reagents for BD MAX™ System – Fact Sheet for Providers
07/27/20Allplex 2019-nCoV Assay – Fact Sheet for Patients
07/27/20Allplex 2019-nCoV Assay – Fact Sheet for Providers
12/23/20Solana SARS-CoV-2 Assay by Quidel – Fact Sheet for Patients
12/23/20Solana SARS-CoV-2 Assay by Quidel – Fact Sheet for Providers

The test is authorized for use by the U.S. Food and Drug Administration (FDA) via an emergency use authorization (EUA).

04/06/21BinaxNOW COVID-19 Ag Card – Fact Sheets for Patients
04/06/21BinaxNOW COVID-19 Ag Card – Fact Sheets for Providers

Aculabs offers SARS-CoV-2 antibody testing – serological testing meant to detect different types of antibodies that develop via the immune response that occurs from exposure to SARS-CoV-2, the virus which causes COVID-19.

The test is done via blood draw. Antibody testing is used at present to track those who may have been previously exposed to the virus yet often were asymptomatic. Aculabs offers testing from various manufacturers, which currently includes SARS-CoV-2 antibody testing developed by Abbott and Roche.

The test is authorized for use by the U.S. Food and Drug Administration (FDA) via an emergency use authorization (EUA).

04/26/20 Abbott SARS-CoV-2 IgG Assay – Fact Sheet for Patients
04/26/20Abbott SARS-CoV-2 IgG Assay – Fact Sheet for Providers

Aculabs offers SARS-CoV-2 antibody testing – serological testing meant to detect different types of antibodies that develop via the immune response that occurs from exposure to SARS-CoV-2, the virus which causes COVID-19.

The test is done via blood draw. Antibody testing is used at present to track those who may have been previously exposed to the virus yet often were asymptomatic. Aculabs offers testing from various manufacturers, which currently includes SARS-CoV-2 antibody testing developed by Abbott and Roche.

The test is authorized for use by the U.S. Food and Drug Administration (FDA) via an emergency use authorization (EUA).

05/02/20Roche Elecsys Anti-SARS-CoV-2 – Fact Sheet for Recipients
05/02/20Roche Elecsys Anti-SARS-CoV-2 – Fact Sheet for Providers

Aculabs offers SARS-CoV-2 antibody testing – serological testing meant to detect different types of antibodies that develop via the immune response that occurs from exposure to SARS-CoV-2, the virus which causes COVID-19.

The test is done via blood draw. Antibody testing is used at present to track those who may have been previously exposed to the virus yet often were asymptomatic. Aculabs offers testing from various manufacturers, which currently includes SARS-CoV-2 antibody testing developed by Abbott and Roche.

The test is authorized for use by the U.S. Food and Drug Administration (FDA) via an emergency use authorization (EUA).

11/25/20Roche Elecsys Anti-SARS-CoV-2 S – Fact Sheet for Patients
11/25/20Roche Elecsys Anti-SARS-CoV-2 S – Fact Sheet for Providers

CDC – Biological Risk Management of Point-of-Care Testing SitesRead
CDC – Considerations for usage of face masks within Assisted Living FacilitiesRead
CDC – Considerations When Preparing for COVID-19 in Assisted Living FacilitiesRead
CDC – COVID-19 Testing Guidelines for Nursing Home Residents & HCPRead
CDC – Interim U.S. Guidance for Management of HCP with Potential Exposure to COVID-19Read
CDC – Key Strategies to Prepare for COVID-19 in Long-Term Care FacilitiesRead
FDA – Surgical Mask and Gown Conservation Strategies for Healthcare ProvidersRead
FEMA – Coronavirus Rumor Control PortalRead

Point of Care Testing Options

Pennsylvania is one of the states rolling out programs, in conjunction with the federal government, to make point-of-care testing more easily available to facilities in order to allow for rapid testing where a result can be produced in as quickly as an hour right by the bedside. The federal government will send to eligible facilities the device in order to perform the waived testing, as well as the tests themselves.

POC testing can be used for diagnostic purposes or for screening. Testing is considered diagnostic when used to identify current infection in a person who has signs or symptoms consistent with COVID-19, or when a person is asymptomatic but has recent known or suspected exposure to SARS-CoV-2. Testing is considered screening when used for persons who are asymptomatic and do not have known or suspected exposure to SARS-CoV-2.

The performance of these tests is dependent on pretest probability. Pre-test probability is the chance that the patient has the disease, estimated before the test result is known. Pretest probability should be informed by using a rolling average of the positivity rate over the previous 7-10 days along with clinical context. Pretest probability needs to be considered when interpreting the results of these tests.

The Quidel Sofia and Sofia 2 Instruments, BD Veritor Plus Systems, and Abbott BinaxNOW COVID-19 Ag CARD make use of antigen tests, which detect fragments of proteins on or within the virus by testing samples collected from the nasal cavity via swab, while the Abbott ID Now is molecular testing.

Aculabs cannot provide the devices or provide the tests for the point-of-care testing, nor supply training on the devices, but encourages facilities who qualify to receive one of the POCT devices from the federal government to apply and make sure they are eligible for waived testing. We have provided a series of resources below to assist facilities who are looking into performing point-of-care testing at their building.

Pennsylvania POTC COVID-19 Resources:

*- Facilities seeking to perform POTC must complete the application for “Certificate of Waiver (Sections I – VI and IX – X)”.

DateImportant Pennsylvania Notices
8/26/20CMS Interm Final Rule related to Testing Staff & Residents August 2020
8/25/20AHCA/NCAL: CMS Announces New Reporting and Testing Requirements for LTCs
8/20/20AHCA/NCAL: CDC Interim Guidance for Rapid Antigen Testing
8/20/20AHCA/NCAL: Point-of-Care Antigen Test Devices Summary
3/6/20Gov. Tom Wolf Issues Proclamation of Disaster Emergency for PA (governor.pa.gov)

Aculabs Begins Implementing SARS-CoV-2 Testing for COVID-19:

April 7, 2020 – Aculabs will immediately begin performing COVID-19 screenings via the BioGX SARS-CoV-2 Reagents for BD MAX™ System, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2. The ability to perform screenings will allow for result reporting within 24 hours, vital to the high-risk populations Aculabs services as the largest diagnostic service provider to long term care and assisted living facilities across the Mid-Atlantic.

The BD MAX™ System also allows for Aculabs to process 24 samples simultaneously and analyze hundreds of samples per day. All testing is to be done at the Aculabs East Brunswick, New Jersey laboratory, where our team has worked diligently to obtain the latest instrumentation for rapid testing and satisfying all stringent state and federal regulations.

On their website, Becton, Dickinson and Company (BD) describes the test screen as follows:

The BD SARS-CoV-2 Reagents for BD MAX System utilizes multiplexed primers and probes targeting RNA from the nucleocapsid phosphoprotein gene (N1 and N2 regions) of the SARS-CoV-2 coronavirus, and the human RNase P gene. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for specific detection of SARS-CoV-2 by amplifying two unique regions of the N gene (i.e., N1 and N2).

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swab samples during infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

The usage of the BioGX SARS-CoV-2 Reagents for BD MAX™ System became available to CLIA-certified laboratories and hospitals across the country when BD and BioGX announced on April 3rd that they were granted emergency use authorization by the FDA for their new diagnostic test for screening for COVID-19. This new access will allow for more timely reporting.

Aculabs has been approved to use the EUA to perform the testing and will begin implementing testing immediately.