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Evaluation of PG‐M3 antibody in the diagnosis of acute promyelocytic leukaemia
Author(s) -
Gupta Sanjeev Kumar,
Sazawal Sudha,
Mahapatra Manoranjan,
Saxena Renu
Publication year - 2010
Publication title -
european journal of clinical investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.164
H-Index - 107
eISSN - 1365-2362
pISSN - 0014-2972
DOI - 10.1111/j.1365-2362.2010.02344.x
Subject(s) - acute promyelocytic leukemia , medicine , antibody , chromosomal translocation , monoclonal antibody , immunofluorescence , myeloid leukaemia , incidence (geometry) , pathology , biology , immunology , cell culture , gene , retinoic acid , physics , optics , genetics , biochemistry
Eur J Clin Invest 2010; 40 (10): 960–962 Abstract Background & objectives Acute promyelocytic leukaemia (APL) is a distinct subtype of acute myeloid leukaemia (AML) characterized by a reciprocal translocation, t(15;17) and a high incidence of life‐threatening coagulopathy. APL diagnosis is considered a medical emergency. As reverse transcription‐polymerase chain reaction (RT‐PCR) for PML‐RARα fusion oncoprotein is time consuming, there is a need for a rapid and accurate diagnostic test for APL. This study evaluates the role of PG‐M3 monoclonal antibody using immunofluorescence (IF) in the early diagnosis of APL. Materials and Methods Thirty‐six new untreated APL cases diagnosed with RT‐PCR for PML‐RARα as the gold standard and 38 non‐APL controls (28 non‐APL AMLs and 10 non‐leukaemic samples) were evaluated by routine morphology and cytochemistry, RT‐PCR and IF using PG‐M3 monoclonal antibody. Results Using IF, 34 of 36 (94·4%) APL cases showed a microgranular pattern suggestive of APL and two cases (5·6%) showed a speckled pattern typical of wild‐type PML protein (False negative). By comparison, two of 28 (7·1%) non‐APL AMLs showed microgranular pattern (false positive). Hence, IF as a diagnostic test for APL resulted in a sensitivity of 94·4%, specificity of 92·9% and positive and negative predictive values of 94·4% and 92·9% respectively. All 10 non‐leukaemic samples showed a speckled pattern. Conclusions IF using PG‐M3 antibodies can be used as a rapid (takes 2 h), cheap, sensitive and specific method to identify APL. It can be a useful adjunct for diagnosis of APL especially if facilities for RT‐PCR are not available, particularly in resource‐limited settings.