LAMPseq is a molecular biological method that can be used to directly detect the pathogens. It represents a qualitatively equivalent and cost-effective alternative to the current standard procedure with the RT-qPCR method. Because of the technology used, the LAMPseq system has a significantly higher throughput than the RT-qPCR method, which allows for a greater increase in the number of corona tests. This is made possible by the use of high-throughput sequencing machines, which are used in molecular biology research and diagnostics.

The LAMPseq method consists of two parts: in the first – the LAMP (Loop-mediated Isothermal Amplification) part of the existing viral genome is amplified. In the second, a large number of samples (up to 100,000) are then analyzed using high-throughput sequencing machines. This process is made possible by an innovative invention of the company’s founders. Before thousands of samples are pooled and analyzed in one sequencing cycle, a molecule (‘molecular barcode’) is incorporated into each individual sample. This barcode ensures that each sample can be assigned without doubt at any time, even after pooling thousands of samples. 

The main advantage of the LAMPseq system is the scalability of the testing. By using the LAMPseq technique, the number of tests done at one time can be significantly increased compared to the RT-qPCR method currently used. This is possible due to the simultaneous analysis of many samples in high-throughput sequencing machines.

Just like the RT-qPCR method, LAMPseq is also based on the detection of the nucleic acid of the pathogens in the respective sample. In both methods the genome is amplified first. In the RT-qPCR method this is done by PCR (polymerase chain reaction), and with LAMPseq by LAMP (loop-mediated isothermal amplification).

In the second step, the pathogens are detected. At this point, the two methods now differ quite substantially. The RT-qPCR method is based on optical devices, so-called qPCR cyclers. The LAMPseq method, on the other hand, uses high-throughput sequencing machines for the detection of coronavirus. This has two advantages: first of all, even medium-sized sequencing machines are capable of analyzing 100,000 samples per day. Secondly, an already existing infrastructure can be used, since such sequencing machines are available in almost all diagnostic and molecular laboratories in Germany. For this reason, the LAMPseq method is ideally suited for high-test throughputs and offers the possibility of establishing systematic and preventive mass testing. The condition for using the sequencing technique – and thus another difference between RT-qPCR and LAMPseq – is the inclusion of a molecular barcode in each individual sample.

To achieve higher throughput, samples are often pooled in the RT-qPCR procedure. This means that, for example, ten samples are mixed and analyzed together. If a negative result is obtained, all ten samples are negative. However, in the case of a positive test result, all samples from the pool must be retested to determine which of the samples is positive. This time-consuming retesting is not necessary with the LAMPseq system. Although a pooling of the samples also takes place here – and this pooling can comprise several thousand samples – the barcode used before testing ensures that each sample can be identified and assigned without doubt during and after analysis by the sequencing machine.

Unlike with RT-qPCR, the LAMPseq method has no need for RNA extraction and enrichment of the genome, or amplification at a constant temperature.

When designing a testing strategy, it is important to first determine the goal of the test. Only then can the best testing procedure be decided. The LAMPseq method has two major advantages when directly compared to the other test methods:

• Higher sensitivity, specificity and throughput than the antigen tests.
• Comparable sensitivity and specificity, but additionally higher throughput than the RT-qPCR tests.

The LAMPseq method has clear advantages when a large number of tests with high sensitivity are required. The LAMPseq method is most useful as a preventive mass test.

The capacities of the LAMPseq method are many times higher than those of the currently used RT-qPCR method. This is because of the machines used for sample analysis. While the RT-qPCR method relies on so-called qPCR cyclers, the LAMPseq procedure is based on sequencing machines. These sequencing machines are typically used for molecular biology research and diagnostics. Even small sequencing machines, of which there are currently several hundred in Germany, can test around 100,000 samples in a ten-hour run. The sequencing machines available in Germany could therefore analyze several million tests per day. These figures make abundantly clear that the test capacity of the LAMPseq procedure is not limited by the technical analysis of the samples.

It takes about 6-8 hours for the swabs to be analyzed by a sequencing machine. The number of samples to be analyzed does not affect the duration of the run. Whether the sequencing machine analyzes 1,000 or 20,000 samples, the duration remains the same. In addition, there is the sample taking process, transport to the laboratory, and sample preparation.

As a rule, the result is available 12 hours after sample entry, meaning the LAMPseq and qPCR method need a similar amount of time.