PMID- 35297205
OWN - NLM
STAT- MEDLINE
DCOM- 20220720
LR  - 20220720
IS  - 1751-553X (Electronic)
IS  - 1751-5521 (Linking)
VI  - 44
IP  - 4
DP  - 2022 Aug
TI  - Interpretation of clot-based lupus anticoagulant assays-Normalizing clotting time 
      against different denominators.
PG  - 777-784
LID - 10.1111/ijlh.13830 [doi]
AB  - OBJECTIVES: The endpoint for all lupus anticoagulant (LA) assays is a clotting 
      time in seconds. This study aimed to clarify the use of normalizing clotting time 
      to ratio and how the use of different denominators is relevant. METHODS: Whether 
      normalization could reduce reagent variability and possess better diagnostic 
      performances was assessed; denominators included reference interval (RI) mean, 
      local-obtained pooled plasma clotting time, standard plasma clotting time, and 
      control plasma clotting time (CNPPct). Moreover, whether day-to-day variation in 
      CNPPct would impact its application was studied. RESULTS: If not normalized, 
      significant difference existed among different reagent batches; if normalized 
      (against any denominators), no statistically significant difference existed 
      anymore. The validation of in-house RIs achieved a 100% success rate. 
      Normalization against different denominators had different RIs, but the same 
      diagnostic efficacies (when a prolonged LA1 is used to suggest further LA-related 
      testings, normalized LA1 demonstrated a better sensitivity: 1.0 vs. 0.95). 
      Normalization against a "daily" CNPPct (obtained alongside test plasmas day to 
      day) demonstrated low inter-day variations (LA1: ~1%, LA2: ~1%), and it could 
      employ the RI for normalization against a "fixed" CNPPct (obtained alongside 
      normal plasmas when the RI was established). CONCLUSIONS: Normalizing clotting 
      time reduces reagent-batch variability and promotes the adoption of common RIs, 
      and therefore reduces the necessity of establishing RI for new reagent batches. 
      Normalized LA1 is more sensitive when used to suggest further LA-related 
      testings, and therefore reduces the rate of missed LA diagnosis. All denominators 
      are of the same application value. Day-to-day variation in CNPPct did not impact 
      its application as a reliable denominator.
CI  - (c) 2022 John Wiley & Sons Ltd.
FAU - Ling, Li-Qin
AU  - Ling LQ
AD  - Department of Laboratory Medicine, West China Hospital, Sichuan University, 
      Chengdu, China.
FAU - Liu, Chao-Nan
AU  - Liu CN
AD  - Department of Laboratory Medicine, West China Hospital, Sichuan University, 
      Chengdu, China.
FAU - Huang, Xun-Bei
AU  - Huang XB
AD  - Department of Laboratory Medicine, West China Hospital, Sichuan University, 
      Chengdu, China.
FAU - Liao, Juan
AU  - Liao J
AD  - Department of Laboratory Medicine, West China Hospital, Sichuan University, 
      Chengdu, China.
FAU - Jia, Jin
AU  - Jia J
AD  - Department of Laboratory Medicine, West China Hospital, Sichuan University, 
      Chengdu, China.
FAU - Zhou, Jing
AU  - Zhou J
AUID- ORCID: 0000-0002-4251-9068
AD  - Department of Laboratory Medicine, West China Hospital, Sichuan University, 
      Chengdu, China.
LA  - eng
GR  - 81371878/National Natural Science Foundation of China/
GR  - 81902126/National Natural Science Foundation of China/
GR  - 2020YFS0254/Sichuan Science and Technology Program/
PT  - Journal Article
DEP - 20220316
PL  - England
TA  - Int J Lab Hematol
JT  - International journal of laboratory hematology
JID - 101300213
RN  - 0 (Lupus Coagulation Inhibitor)
SB  - IM
MH  - *Blood Coagulation
MH  - Blood Coagulation Tests
MH  - Humans
MH  - *Lupus Coagulation Inhibitor
MH  - Partial Thromboplastin Time
MH  - Plasma
MH  - Reference Values
OTO - NOTNLM
OT  - lupus anticoagulants
OT  - normal pooled plasma clotting time
OT  - normalization
OT  - reference interval mean
EDAT- 2022/03/18 06:00
MHDA- 2022/07/22 06:00
CRDT- 2022/03/17 05:37
PHST- 2022/02/24 00:00 [revised]
PHST- 2021/12/31 00:00 [received]
PHST- 2022/03/02 00:00 [accepted]
PHST- 2022/03/18 06:00 [pubmed]
PHST- 2022/07/22 06:00 [medline]
PHST- 2022/03/17 05:37 [entrez]
AID - 10.1111/ijlh.13830 [doi]
PST - ppublish
SO  - Int J Lab Hematol. 2022 Aug;44(4):777-784. doi: 10.1111/ijlh.13830. Epub 2022 Mar 
      16.