Could you please go through the following papers
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC228917/
http://www.ncbi.nlm.nih.gov/pubmed/20093764
http://www.biomedcentral.com/1471-2334/10/118
To claim so, the primer sets used for diagnosis by PCR must be proved for their specificity and sensitivity as well as for their robustness (upon use for routine analysis). All of them in both the ways theoretically and practically. Having this data in hand and with confidence, further by sequencing of obtained specific PCR product for confirmation can serve as background work and standardization. If it is a probe based qPCR, it is very easy to claim.
If everything is set fine, one can proceed for routine diagnosis using PCR as a cheep and best and also a rapid method than any other.
With all good handling and practices PCR stands 4th in top 5.
we have develloped a qPCR for analysis the presence of Mycobacteria in all type of sample (mainely environemental, but ...).
Article AtpE gene as a new useful specific molecular target to quant...
Molecular diagnosis of TB has seen advancement in recent times with number of PCR assays been developed for MTB detection in different clinical specimen. However one of the major setback of diagnosis of mycobacterium in blood is lack of sensitivity. Such test may be used in cases which are culture positive, since major issues with PCR is lack of correlation between culture positivity and PCR positivity. If culture is positive, it may be used as supportive test.
Both sensitivity and specificity of PCR assays are dependent on important factors such as load of TB bacteria in blood, volume,efficacy of DNA extraction protocol, copy number of gene targeted. One major limitation is lack of ability of Molecular assays to differentiate live and dead bacilli, since person on AKT may also show PCR positivity.
Nested PCR assays assays are today promising approach for diagnosis. However success of such assays ultimately depends on clinical correlation and combinatorial approach with other supportive tests.
In under developed countries the cost of PcR is very high. A positive tuberculin test in the absences of BCG helps better than pcR