scholarly journals Blood Safety: On-Site Verification Of The Screening Of HIV, HBV And HCV By Enzyme Linked Immuno-Sorbent Assay (ELISA) Kits From Bio-Rad Laboratories At The “Centre National De Transfusion Sanguine” (CNTS) Of Lomé In Togo

2021 ◽  
Vol 17 (21) ◽  
pp. 92
Author(s):  
Gnatoulma Katawa ◽  
Christèle Nguepou Tchopba ◽  
Marthe Oukoé Amessoudji ◽  
Pelagie Edlom Tchadié ◽  
Simplice Damintoti Karou ◽  
...  

Background: Blood transfusion improves health and saves lives. Safe blood must be ensured for our populations. Quality assurance is a process that includes a set of coordinated activities in order to achieve the quality objective. Compliance with the quality management rules of medical biology laboratories requires verification of methods prior to their use. This study aimed to verify the on-site verification of the performance of the Enzyme Linked Immuno-Sorbent Assay (ELISA) method performed at the serology laboratory of the CNTS of Lomé. Methods: The performance of ELISA method performed at the serology laboratory of CNTS for the diagnosis of HIV, Hepatitis B and C with Bio-Rad Genscreen ULTRA-HIV Ag-Ac, Bio-Rad Monolisa-HBs Ag ULTRA and Bio-Rad Monolisa HCV Ag-Ac ULTRA V2 kits respectively was evaluated on repeatability, reproducibility, sensitivity and specificity according to COFRAC's SH GTA 04 reference. Results: The evaluation of the repeatability and reproducibility of each kit used in the laboratory resulted in compliant Coefficients of Variation (CV) with manufacturers’ ones. Sensitivities obtained with Bio-Rad Monolisa HCV Ag-Ac ULTRA V2, Bio-Rad Monolisa HBs Ag ULTRA and Bio-Rad Genscreen ULTRA HIV Ag-Ac kits were 94.59%, 98.08% and 100% respectively. For specificity tests, we found 86.49% with BIO-Rad Genscreen ULTRA-HIV Ag-Ac kit, 94.34% with Bio-Rad Monolisa HCV Ag-Ac ULTRA V2 kit and 97.37% with Bio-Rad Monolisa-HBs Ag ULTRA. Conclusion: In general, results were compliant except HIV diagnosis specificity. This study appears as a contribution to the establishment of a verification file for ELISA method used at the serology laboratory of CNTS of Lomé.

2021 ◽  
Vol 2 (1) ◽  
pp. 46-50
Author(s):  
Bagus Triatmojo

HIV cases in Jepara District in recent years have demanded the handling of several aspects simultaneously including the Blood Transfusion Unit (BTU). HIV can be transmitted through blood transfusion or other blood products. BTU of PMI Jepara Regency carries out recruitment of voluntary donor from Jepara society. The HIV examination as part of an IMLTD screening test is done for safety of donor blood. The HIV examination in all donor blood uses rapid and elisa method. Examination results are stated as reactive and non reactive. Research objective to find out the description of HIV examination results in donor blood at the BTU of PMI Kabupaten Jepara in 2019. Research method the research type was descriptive using records of donor data at BTU of PMI Kabupaten Jepara in 2019. The examination results of reactive HIV in 12 donor blood (0,08%). non-reactive blood donor of HIV  in age groups 18 years, 18-24, 25-44, 45-59, and ≥ 60 years respectively 9,55%, 22,39%, 51,75%, 16,01% and 0,21%. Reactive HIV in age groups 18-24, 25-44, and 45-59 years were 0,034%, 0,034%, and 0,13%. Non-reactive HIV in men 68,22% and in women 31,70%. Reactive HIV in men 0,07%, and women 0,01%. Non-reactive HIV in voluntary donor blood was 99,779% and substitute donor was 0,127%. HIV of reactive voluntary donor blood was 0,074%, and substitute donor was 0,007%. HIV filter test is indispensable for blood safety because the age, gender and blood type of donors have the potential for reactive HIV.


Author(s):  
Cas W Weykamp ◽  
Theo J Penders ◽  
Frits A J Muskiet ◽  
Willem van der Slik

Stable lyophilized ethylenediaminetetra-acetic acid (EDTA)-blood haemolysates were applied in an external quality assurance programme (SKZL, The Netherlands) for glycohaemoglobin assays in 101 laboratories using 12 methods. The mean intralaboratory day-to-day coefficient of variation (CV), calculated from the assay of 12 unidentified pairs over a period of 1 year, was 5·2% (range: 0·2–28·7). Forty-seven per cent of laboratories did not meet the criterion of CV < 5%, whereas 68% did not meet the clinically more desirable 3·3–3·6%. Linearity, as derived from the analysis of five combinations of two haemolysates with low and high glycohaemoglobin percentages over 6 months, was excellent (mean correlation coefficient 0·9953; range: 0·9188–0·9999). Analysis of two samples with high and low glycohaemoglobin percentages gave mean interlaboratory coefficients of variation of 10% for one method performed by several laboratories and 22% for all methods performed by all laboratories. It is concluded that the majority of laboratories do not meet the clinically desirable intralaboratory precision and that an unacceptably high interlaboratory precision exists.


1980 ◽  
Vol 63 (1) ◽  
pp. 37-42 ◽  
Author(s):  
Ross J Norstrom ◽  
Henry T Won ◽  
Micheline Van Hove Holdrinet ◽  
Patrick G Calway ◽  
Caroline D Naftel

Abstract Mirex and photomirex (8-monohydromirex) were separated from polychlorinated biphenyls (PCBs) and other aromatic compounds by nitration with fuming nitric acid-concentrated sulfuric acid and removal of nitro-PCBs on an alumina microcolumn; the compounds were then determined by gas-liquid chromatography. Recoveries of Mirex and photomirex were 102±8 and 104±5%, respectively, from standard solutions which had a PCB-to-Mirex and photomirex ratio of 1000. Recoveries from fortified, uncontaminated samples of sediment, fish, and eggs averaged 93±7 and 92±3% for Mirex and photomirex, respectively. The coefficients of variation for repeatability and reproducibility averaged 8 and 15%, respectively, in an interlaboratory study conducted by 4 laboratories using extracts of naturally contaminated substrates (sediment, carp, eel, and gull egg). Levels of Mirex in the samples ranged from 0.1 to 8 mg/kg, and levels of PCB ranged from 0.5 to 166 mg/kg.


1988 ◽  
Vol 71 (2) ◽  
pp. 276-279
Author(s):  
Margaret A Clarke ◽  
Mary An Godshall

Abstract A collaborative study was conducted using the Roberts copper method for the determination of dextran in raw cane sugars. Four samples were analyzed in duplicate, representing the range of dextran concentrations found in raw sugar. The overall repeatability and reproducibility coefficients of variation were 4.3 and 13.2%, respectively. The method has been adopted official first action.


1984 ◽  
Vol 67 (2) ◽  
pp. 232-236
Author(s):  
Nrisinha P Sen ◽  
Stephen Seaman ◽  
K Karpinsky ◽  
◽  
M Castegnaro ◽  
...  

Abstract Ten laboratories participated in a collaborative study of a method for the determination of JV-nitrosodimethylamine (NDMA) in nonfat dry milk. NDMA is eluted with dichloromethane from a mixture of Celite, acidic sulfamic acid, and nonfat dry milk (all packed in a chromatography column), concentrated in a Kuderna-Danish concentrator, and finally analyzed by a GC-thermal energy analyzer technique. Ten samples were studied: 6 were naturally contaminated (NDMA levels 0.38- 3.56 ppb) and 4 were spiked with known levels (0.96 and 3.2 ppb) of NDMA. The coefficients of variation (CV) of the complete data for the naturally contaminated samples (excluding the 2 samples containing the lowest levels) were 8.5% and 22.5% for repeatability and reproducibility, respectively. The corresponding CVs for the spiked samples were 14.4% and 20.4%, respectively. The percent recoveries of the added NDMA in the spiked samples (at the 2 levels indicated above) were 101.6 ± 3.2 (omitting 1 outlier) and 95 ∓ 2.1, respectively. The method has been adopted official first action.


1984 ◽  
Vol 67 (3) ◽  
pp. 521-525
Author(s):  
Walter Fiddler ◽  
John W Pensabene ◽  
Robert A Gates ◽  
John G Phillips ◽  
◽  
...  

Abstract A dry column method for isolating N-nitrosopyrrolidine (NPYR) from fried, cure-pumped bacon and detection by gas chromatography-thermal energy analyzer (TEA) was studied collaboratively. Testing the results obtained from 11 collaborators for homogeneous variances among samples resulted in splitting the nonzero samples into 2 groups of sample levels, each with similar variances. Outlying results were identified by AOAC-recommended procedures, and laboratories having outliers within a group were excluded. Results from the 9 collaborators remaining in the low group yielded coefficients of variation (CV) of 6.00% and 7.47% for repeatability and reproducibility, respectively, and the 8 collaborators remaining in the high group yielded CV values of 5.64% and 13.72%, respectively. An 85.2% overall average recovery of the N-nitrosoazetidine internal standard was obtained with an average laboratory CV of 10.5%. The method has been adopted official first action as an alternative to the mineral oil distillation-TEA screening procedure.


Transfusion ◽  
2018 ◽  
Vol 58 (5) ◽  
pp. 1299-1306 ◽  
Author(s):  
Louis M. Katz ◽  
John J. Donnelly ◽  
Christopher J. Gresens ◽  
Jerry A. Holmberg ◽  
James MacPherson ◽  
...  

2021 ◽  
Author(s):  
Xiyu Zhang ◽  
Zhihui Tang ◽  
Haoyan Niu ◽  
Liping Yan ◽  
suquan song

Abstract The feline calicivirus (FCV), feline herspesvirus 1 (FHV-1) and feline panleukemia virus (FPV) are heavily threaten the health of cats. In this study, a triplex TaqMan real-time polymerase chain reaction (RT-PCR) assay (triplex assay) was developed to detect these viruses. The optimized concentration of primers was 0.5 µM of each, probes concentration was 0.1 µM for FCV and FHV-1, 0.05 µM for FPV. The annealing temperature was set at 54 ℃. The triplex RT-PCR assay was carefully validated. The detection limit for FPV, FCV, and FHV-1 was 5×101 copies/µL, which showed a 10-100-fold increase in the sensitivity compared with the conventional PCR. The coefficients of variation (CV) of the intra-assay variability of the test were < 1.86%, and that of inter-assay was < 3.19%, indicating excellent repeatability and reproducibility of the triplex assay. Additionally, the assay has perfect specificity. In a pilot study, samples from 48 cats were analyzed using the triplex RT-PCR method and the commercial kits, and further confirmed by sequencing. The positive rates for the samples analyzed with these two methods were 70.83% and 62.5%, respectively, which demonstrated that the developed method was more accurate than the commercial kits in clinical diagnosis.


2007 ◽  
Vol 13 ◽  
pp. 289-291
Author(s):  
L.R. Briggs ◽  
J.M. Sprosen ◽  
B.A. Tapper ◽  
H.S. Easton

Tests are required to monitor contamination of AR1-infected seed with ryegrass seed infected with the common toxic endophyte to ensure contamination is maintained below 5% for First Generation seed and below 2% for Breeders and Basic seed. To achieve this AR1 seed is tested for the presence of lolitrem toxins that are produced by the endophytic fungus in toxic seeds. This was done by HPLC analysis until 2006 when an ELISA method, more suited to processing large sample numbers, was successfully established as a replacement. The ELISA is specific for lolitrems and lolitriol, provides rapid sample turnaround and analytical costs have been reduced. It is anticipated that in the future the test will be transferred to a commercial testing laboratory and will be extended to monitor contamination of AR37 seed with common toxic ryegrass seed. Keywords: AR1 ryegrass, wild-type endophyte, lolitrem, ELISA, quality assurance


Author(s):  
P. K. Sehgal ◽  
Dinesh Garg

Background: Blood donor base is the foundation of any blood transfusion system. In India any able-bodied individual between the age of 18 and 60 years can donate blood. Blood donors are of two types: voluntary donors and replacement donors. Blood donation should be done by low risk population otherwise there is high risk of transfusion transmissible infections like HIV, hepatitis B, hepatitis C and malaria. The present study was conceived to see the patterns of blood donation among voluntary and replacement blood donors in tertiary care centre.Methods: In this study 50 (27 male and 23 female) adult skulls were investigated to determine the type of asterion, its distance from important bony landmarks and also the nearby venous sinuses were measured.Results: Of the total 340078, 298421(87.75%) collections were voluntary and 41657(12.25%) were replacement collections. A total of 2810 camps were held to gather blood through voluntary donors. Number of blood camps held show an increasing pattern as we progress in time. Also, the trends in voluntary blood donations increased over the period and more donors donated blood whereas replacement donors decreased over the period and eventually vanished in time.Conclusions: For a safe blood service in our country, where comprehensive laboratory tests are neither possible nor pragmatic, it is best to switch over to 100% voluntary donations, as it is now established that only voluntary non-remunerated regular donation is the safest. Thus, one of our key strategies to enhance blood safety is to focus on motivating non-remunerated blood donors and phasing out even replacement donors.


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