title: Evaluation of PG-M3 antibody in the diagnosis of acute promyelocytic leukaemia.
abstract: OBJECTIVE
  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-RAR 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.
  
  
  METHODS
  Thirty-six new untreated APL cases diagnosed with RT-PCR for PML-RAR 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.
authors.affiliation: Department of Haematology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Sanjeev Kumar
authors.initials: SK
authors.lastname: Gupta
authors.forename: Sudha
authors.initials: S
authors.lastname: Sazawal
authors.forename: Manoranjan
authors.initials: M
authors.lastname: Mahapatra
authors.forename: Renu
authors.initials: R
authors.lastname: Saxena
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000191:economics; D016022:Case-Control Studies; D002648:Child; D005260:Female; D005455:Fluorescent Antibody Technique / Q000191:economics; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D013997:Time Factors; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal