Response to article titled "US-funded measurements of cervical cancer death rates in India: scientific and ethical concerns" by Eric J Suba.

Dr Eric Suba has been distorting facts and persistently disseminating biased and misleading views and statements regarding our studies over the past several years. His article in the Indian Journal of Medical Ethics fails to mention the facts that seem unfavourable to his arguments, and the ethical concerns are unsubstantiated by the evidence. In this context, we present the following clarifications for the attention of your readers, notably with regard to: (i) the study design and inclusion of a control group; (ii) the informed consent of the women participating in the study; (iii) the conformity with international ethical standards and guidelines, and (iv) the provision of screening to women in the control arm of the studies. We also highlight the benefits that are flowing from this research and the risk that misinformation may further delay access for women to life-saving cervical cancer screening.

An in-house multiplex PCR test for the detection of Mycobacterium tuberculosis, its validation & comparison with a single target TB-PCR kit.

Background & objectives: The conventional techniques used in TB diagnosis like AFB (acid fast bacilli) smear microscopy lack sensitivity and the gold standard, culture test takes time. A test based on multiplex polymerase chain reaction (PCR) targeting the 38 kDa gene and IS6110 insertion sequence, specific to Mycobacterium tuberculosis was developed to further increase the sensitivity of a TB-PCR kit targeting only 38 kDa gene developed earlier in the same laboratory. The multiplex test was validated using sputum samples from pulmonary TB (PTB) cases. The sensitivity and specificity were compared with AFB smear examination and Lowenstein-Jensen (LJ) culture test. Methods: Multiplex PCR amplifying 340 and 245 bp sequence of 38 kDa gene and IS6110, respectively was standardized and analytical sensitivity was verified. Sputum samples (n=120) obtained from PTB cases were subjected to AFB smear examination, LJ culture and a multiplex as well as single target PCR test. Additionally, 72 non-TB respiratory samples were included in the study as negative controls. Results: Analytical sensitivity of multiplex PCR was found to be 100 fg for 38 kDa gene and 1 fg for IS6110. Multiplex PCR, using both the targets, showed highest sensitivity of 81.7 per cent, followed by 69.2 per cent for L-J culture test and 53.3 per cent for AFB smear when clinical diagnosis was considered as a gold standard. The sensitivity of detection of M. tuberculosis in AFB smear positive and negative samples by multiplex PCR was 93.7 and 67.9 per cent, respectively. Sensitivity of 77.1 per cent observed for the detection of M. tuberculosis with single target PCR increased to 89.2 per cent with multiplex PCR in culture positive samples. Four samples showed positive PCR results only with primers for 38 kDa gene. Interpretation & conclusions: Multiplex PCR increased the sensitivity of single target PCR and will be useful in diagnosing paucibacillary smear negative samples. Further, it can also be used to detect samples with M. tuberculosis strains lacking IS6110.

Bile cultures and sensitivity patterns in malignant obstructive jaundice.

BACKGROUND: Bactibilia is one of the important factors in the development of postoperative septic complications. We undertook this retrospective analysis to identify the organisms present in bile and their antibiotic susceptibility patterns in patients with malignant obstructive jaundice. METHODS: Bile specimens were obtained during endoscopic cholangiography (ERC; n=65), by flushing biliary stents (n=15), intra-operatively before incising the common bile duct (n=7) or during percutaneous transhepatic biliary drainage (PTBD; n=1). Eighty-eight samples from 65 consecutive patients were analyzed for their bacterial spectrum and sensitivity to antibiotics. Concomitant septic complications such as wound infection and cholangitis were also assessed. RESULTS: Of 65 patients (hilar block 39, distal block 26), 17 (26.1%) had bactibilia at initial ERCP; in addition, 3 of 7 bile specimens obtained during surgery, one collected during PTBD, and 13 of 15 stent flushings grew bacterial organisms. Cholangitis developed in 15 patients (12 with hilar block, 3 with distal block). Blood cultures were positive in 3 cases, and initial bile culture was positive in four patients with cholangitis. The most commonly found organisms were Escherichia coli (36.6%), Klebsiella pneumonia (18.3%), Pseudomonas aeruginosa (8.3%), Proteus vulgaris (8.3%) and coagulase-negative staphylococci (8.3%). The organisms found on ERC were similar to those found at wound cultures in 3 of the 4 cases who developed wound infection. Amikacin, gentamicin, cefotaxime, ceftazidime, and cefoperazone-sulbactam combination showed good activity against E. coli and K. pneumonia. CONCLUSION: Approximately one-fourth of patients with malignant obstructive jaundice have positive bile cultures at initial ERC. Post-ERC cholangitis is common in hilar blocks.