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23
Feb

In-house methods: do they still have a place in the modern laboratory?

To answer the question above we first need to identify the kind of laboratory we are talking about. For the typical diagnostic laboratory, the answer is no! Rigorous quality control standards demand that the methods used in the routine procedures must be thoroughly tested and validated before being used in any diagnostic test. Considering that this kind of laboratory already has a heavy workload of daily diagnostic tests, it is not cost-effective to develop in-house diagnostic procedures. In addition to these technical issues, there are the extensive and complicated regulatory standards imposed by governmental agencies in order to protect the patient and customer safety. Thus, for a laboratory that performs strictly regulated activities (human health, agricultural, and veterinary tests) it is not expected (or desirable) that technical development initiatives be undertaken without a careful risk/return analysis. But does it mean that such a laboratory can never be involved in any technical development? Again, the answer is no, but this depends on the available resources such as personnel, financial capacity, and, most importantly, the time needed to accomplish the full developmental cycle (hypothesis testing, research, development, obtaining investment funding, fabrication, clinical testing, validation, regulatory approval, scale production, marketing, diagnostic service). Taking all this into account, only the big organisations have the breath to carry out these development activities completely. Small labs are only able to carry out the first three to four steps.

If we think about the typical research laboratory, we get a slightly different picture. Labs that are advancing through the frontiers of knowledge can boost their productivity and save post-doc working hours (even though its cheap!) by buying from the big biomolecular/biotech vendors and get clean results from the high quality kits and reagents available for a small (?) sum of money. After all, fast and high quality results (i. e., to be publishable in prestigious journals according to the most competitive academic standards) are the ultimate goal of every leading laboratory at the current time! Well, this works fine if we have the method, the instrument, the kit, and accompanying reagents right in our hands (and enough grant money, of course). The problem is: labs that venture deeply into the unknown usually do not have such an availability of methods, instruments, kit, or reagents! No vendor, no biotech, or biological provider, market products that no one has ever developed. So, the solution is to develop them yourself. Researchers in this kind of lab are the pioneers, and thus they can establish their own protocols, methods, new reagents, standards, and control procedures. These seem to be the paradise for those claiming research freedoms to advance knowledge. No regulatory body telling you what we can or cannot do, no weird rule you must obey to get project and funding approval. Simply go to the lab, ask questions, formulate your hypothesis, design the experiments, get data, refute or not the hypothesis, publish the impressive and revolutionary results you have obtained: what a beautiful scientific world!

It is a pity, however, that such a world does not exist. The real life in the lab teaches us that even when we venture deeply into the unknown we cannot freely perform the experiments. We have to follow certain rules (biosafety concerns, environmental guidelines, quality control standards) and we must do a little bit of “normal” science. After all, our graduate students should present their thesis at the end of their doctoral training, and this must be a successful account of all experiments done in the lab. The science praxis of our times does not allow us to report failed experiments or partially accomplished projects. Due mainly to the risks associated in going to “no man's land” (imagine your grant not being renewed by failure in get convincing - and publishable - results in the last year!) that only a few and (bold) labs can afford this kind of research. Fortunately, contemporary science is too competitive and diverse that for every question we try to answer there is someone in some place using an alternative approach to solve it. We can both benefit from and contribute to this by advancing our own ideas/projects and leveraging that knowledge a step further. That is what we expect when we decide to publish a methods paper: it might leverage the knowledge in that particular field and might also spark new ideas and solutions to common problems in infectious diseases. In the February 2016 [111(2)] issue of Memórias do Instituto Oswaldo Cruz, two articles describe alternative methods that in some way relate to the subjects mentioned above:

(i) A molecular platform for the diagnosis of multidrug-resistant and pre-extensively drug-resistant tuberculosis based on single nucleotide polymorphism mutations present in Colombian isolates of Mycobacterium tuberculosis, by Martínez et al.

(ii) An in-house real-time polymerase chain reaction: standardisation and comparison with the Cobas Amplicor HBV monitor and Cobas AmpliPrep/Cobas TaqMan HBV tests for the quantification of hepatitis B virus DNA, by Santos et al.

We are not alone in the science paradise, even if we have the privilege of the pioneer's knowledge about the new field we are venturing into. That is the beauty of science!

 

Editor

Adeilton Brandão

 

REFERENCES

  1. Martínez LMW, Castro GP, Guerrero MI 2016. A molecular platform for the diagnosis of multidrug-resistant and pre-extensively drug-resistant tuberculosis based on single nucleotide polymorphism mutations present in Colombian isolates of Mycobacterium tuberculosis. Mem Inst Oswaldo Cruz 111: 93-100.

  2. Santos APT, Levi JE, Lemos MF, Calux SJ, Oba IT, Moreira RC 2016. An in-house real-time polymerase chain reaction: standardisation and comparison with the Cobas Amplicor HBV monitor and Cobas AmpliPrep/Cobas TaqMan HBV tests for the quantification of hepatitis B virus DNA. Mem Inst Oswaldo Cruz 111: 134-140. 

To answer the question above we first need to identify the kind of laboratory we are talking about. For the typical diagnostic laboratory, the answer is no! Rigorous quality control standards demand that the methods used in the routine procedures must be thoroughly tested and validated before being used in any diagnostic test. Considering that this kind of laboratory already has a heavy workload of daily diagnostic tests, it is not cost-effective to develop in-house diagnostic procedures. In addition to these technical issues, there are the extensive and complicated regulatory standards imposed by governmental agencies in order to protect the patient and customer safety. Thus, for a laboratory that performs strictly regulated activities (human health, agricultural, and veterinary tests) it is not expected (or desirable) that technical development initiatives be undertaken without a careful risk/return analysis. But does it mean that such a laboratory can never be involved in any technical development? Again, the answer is no, but this depends on the available resources such as personnel, financial capacity, and, most importantly, the time needed to accomplish the full developmental cycle (hypothesis testing, research, development, obtaining investment funding, fabrication, clinical testing, validation, regulatory approval, scale production, marketing, diagnostic service). Taking all this into account, only the big organisations have the breath to carry out these development activities completely. Small labs are only able to carry out the first three to four steps.

            If we think about the typical research laboratory, we get a slightly different picture. Labs that are advancing through the frontiers of knowledge can boost their productivity and save post-doc working hours (even though its cheap!) by buying from the big biomolecular/biotech vendors and get clean results from the high quality kits and reagents available for a small (?) sum of money. After all, fast and high quality results (i. e., to be publishable in prestigious journals according to the most competitive academic standards) are the ultimate goal of every leading laboratory at the current time! Well, this works fine if we have the method, the instrument, the kit, and accompanying reagents right in our hands (and enough grant money, of course). The problem is: labs that venture deeply into the unknown usually do not have such an availability of methods, instruments, kit, or reagents! No vendor, no biotech, or biological provider, market products that no one has ever developed. So, the solution is to develop them yourself. Researchers in this kind of lab are the pioneers, and thus they can establish their own protocols, methods, new reagents, standards, and control procedures. These seem to be the paradise for those claiming research freedoms to advance knowledge. No regulatory body telling you what we can or cannot do, no weird rule you must obey to get project and funding approval. Simply go to the lab, ask questions, formulate your hypothesis, design the experiments, get data, refute or not the hypothesis, publish the impressive and revolutionary results you have obtained: what a beautiful scientific world!

            It is a pity, however, that such a world does not exist. The real life in the lab teaches us that even when we venture deeply into the unknown we cannot freely perform the experiments. We have to follow certain rules (biosafety concerns, environmental guidelines, quality control standards) and we must do a little bit of “normal” science. After all, our graduate students should present their thesis at the end of their doctoral training, and this must be a successful account of all experiments done in the lab. The science praxis of our times does not allow us to report failed experiments or partially accomplished projects. Due mainly to the risks associated in going to “no man's land” (imagine your grant not being renewed by failure in get convincing - and publishable - results in the last year!) that only a few and (bold) labs[U1]  can afford this kind of research. Fortunately, contemporary science is too competitive and diverse that for every question we try to answer there is someone in some place using an alternative approach to solve it. We can both benefit from and contribute to this by advancing our own ideas/projects and leveraging that knowledge a step further. That is what we expect when we decide to publish a methods paper: it might leverage the knowledge in that particular field and might also spark new ideas and solutions to common problems in infectious diseases. In the February 2016 [111(2)] issue of Memórias do Instituto Oswaldo Cruz, two articles describe alternative methods that in some way relate to the subjects mentioned above:

            (i) A molecular platform for the diagnosis of multidrug-resistant and pre-extensively drug-resistant tuberculosis based on single nucleotide polymorphism mutations present in Colombian isolates of Mycobacterium tuberculosis, by Martínez et al.

            (ii) An in-house real-time polymerase chain reaction: standardisation and comparison with the Cobas Amplicor HBV monitor and Cobas AmpliPrep/Cobas TaqMan HBV tests for the quantification of hepatitis B virus DNA, by Santos et al.

            We are not alone in the science paradise, even if we have the privilege of the pioneer's knowledge about the new field we are venturing into. That is the beauty of science!


 [U1]Ele quer que coloque algo em negrito? Ou não é isso?

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