About Us

Genesis

ABC was created in response to the unprecedented challenges of covid-19 as an impact project. Initially built and deployed over seven weeks, ABC has worked closely with the Swedish Public Health Agency to conduct up to 25% of all national testing for covid-19. Our culture is defined by speed, agility, and innovation without ever compromising the highest standard of quality. Through partnerships with academic scientists, we created unique products that enabled the Swedish national screening program for the Alpha, Delta, and Omicron variants as well as the first test for measuring t-cell immunity in Europe.

ABC: Lab for the Future

We believe the pandemic has changed diagnostics and healthcare forever and there will be unprecedented demand for, among other things, home testing and preventative health screening. To do this at scale, we are now creating a digital infrastructure around testing that better integrates healthcare providers, labs, and patients to make diagnostics more affordable, accessible, and readily available.

Test Portfolio

ABC offers the full suite of SARS-CoV-2 diagnostics including NGS, T-Cells, IgG/IgA/IgM antibodies, and PCR. We are now building products for digital medicine, national screening programs, and specialist care.

Coronavirus SARS‑CoV‑2‑RNA

Method name:

Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)

Extraction based RT-PCR with ThermoFisher TaqPath™ COVID-19 CE IVD RT-PCR kit
Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)

Used:

To detect SARS-CoV-2 nucleic acid (RNA)

Interpretation:

Positive / Negative / Invalid

A positive test result indicates that the patient is infected with SARS-CoV-2. Laboratory test results should always be considered in the context of clinical observations and epidemiologic data in making a final diagnosis.

A negative test result suggests that the patient is not infected with SARS-CoV-2 at the time of testing. This can also depend on the stage of the covid-19 infection or /and the quality of the collected sample.

An invalid test result suggests that the patient may have a very low amount of viral nucleic acid present in the sample that does not reach the threshold to be considered positive by the assay. Repeat the testing with a new sample, if clinically indicated.

PCR Test Instructions

Coronavirus SARS-CoV-2 serologi

Method name:

Elisa (Enzyme Linked immunosorbent assay)

Used:

To qualitative (nucleokapsid -(N) or spike protein receptor binding domain (S1/RBD)) or quantitative (S1/RBD) detect antibodies (ab) of class IgG against SARS-CoV-2 proteins (nucleocapsid protein – (N) or spike protein receptor binding domain (S1/RBD)). To detect an immune response after covid-19 infection (N, S1/RBD, ab) (2-4 weeks after covid-19) or an immune response after vaccination (S1/RBD, ab) (2 doses of vaccine and after 3weeks).

Specimen type:

Whole blood in serum tube
Whole Blood in Capitainer qDBS-card

Collection container/tube:

Serum tube with gel and coagulation activator, tube size 5 ml
Capitainer qDBS-card

Sampling Instruction for Care Provider - Serum tube (PDF)

Sampling Instruction for Care Provider - Capitainer qDBS (PDF)

Specimen volume:

5 ml serum whole blood
2 x 10 µL qDBS

Release time of the test result:

3 - 5 days

Interpretation:

Quantitative (U/mL): Negative / Low Positive / Medium Positive / High Positive

Qualitative: Positive / Negative

A positive result indicates that SARS-CoV-2 antibodies of class IgG are detected. It suggests a prior infection with SARS-CoV-2 (N-, S1/RBD- IgG, ab).

An increase in IgG levels against the spike protein (S1/RBD-IgG, ab) supports also an adequate vaccination response. The current vaccines in Sweden (Astra-Zeneca, Moderna, Pfizer BioNTech) create antibodies against only the spike protein.

The capitainer qDBS cards can detect antibodies against the spike protein receptor binding domain (S1/RBD)

A negative antibody test result suggests no previous exposure to SARS-CoV-2. However, a negative antibody test may be the result if an individual gets tested too soon after exposure or if the sample is from a immunocompromised individual. In addition, a small proportion of previously infected individuals may not produce antibodies following infection.

The tests satisfy Folkhälsomyndighetens criteria according to Vägledning för antikroppspåvisning.

SARS-CoV-2 T cell EliSpot

Method name:

Enzyme-linked immunospot (EliSpot)

T-cells from individuals are incubated with pool peptides from SARS-CoV-2 as well as control stimuli. The number of T-cell clones that are activated to release IFN-γ are detected by capture antibody, developed and enumerated.

Used:

To detect Spike antigen specific T-cell reactivity in order to identify T-cell memory after infection or to verify response to vaccination against SARS-CoV-2.

Specimen type:

Whole Blood

Collection container/tube:

Sodium heparin tube, without gel

Sampling Instruction for Care Provider (PDF)

Specimen volume:

9 mL (tube size)

Minimum volume whole blood: 6ml

Release time of the test result:

2-3 days

Interpretation:

Positive / Negative

A positive result indicates recognition of SARS-CoV-2 peptides from T-cells as a sign of memory T-cell activation after an infection or after vaccination.

A negative result suggests no previous exposure to SARS-CoV-2 and no recognizable T-cells response.

Method name:

Next-generation sequencing (NGS) / Illumina sequencing

Used:

To identify the different SARS-CoV-2 variants including variants of concerns (VOCs), such as Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2) and Omicron (B.1.1.529). VOCs are associated with increased transmissibility or even disease severity, possible impact on molecular diagnostic assays, possible reduced neutralization by antibodies from previous infection or vaccination, and reduced efficacy of monoclonal antibody therapy.

For monitoring of contact tracing and enhancing public health control measures.

Specimen:

Pure RNA

Specimen volume:

8.5 uL

Release time of the test result:

3-4 days

Interpretation:

SARS-CoV-2 variants get a final PANGO-lineage classification determined by the Pangolin (Phylogenetic Assignment of Named Global Outbreak LINeages) software.

An invalid result indicates poor sequence quality resulting from the presence of inhibitors and/or a low amount of the virus present in the sample or the viral genome may only have been present in a fragmented state.

Our Team

Accreditation

ABC Labs AB is accredited (accred. no. 10532 by SWEDAC) for testing in ISO 15189 Medical laboratories -Requirements for quality and competence. Testing at ABC is covered by both national and international quality assurance programs. ABC also offers testing services that are not included in the scope of accreditation, in the case of a requested testing have an accredited method this will always be applied unless something else is requested.

A result report provided with an accreditation symbol or with a text reference to accreditation is called an accredited result report. Some of the reporting media i.e., patient journal systems, does not allow marking of which methods are accredited and which are not. In these cases, an accredited result report can be supplied for testing carried out with an accredited method upon request.

Certificate of Accreditation, including the scope, can be found on Swedac’s website.

Test Portfolio

PCR

ELISA

ELISPOT

NGS

Our Team

Management Team

Accreditation