Trichomonas vaginalis, antigen and nucleic acid detection

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External Quality Assessment Scheme

Trichomonas vaginalis, antigen and nucleic acid detection Round 2, 2019 Welcome to participate in the EQA round for Trichomonas vaginalis, antigen and nucleic acid detection. Specimens Please find enclosed three liquid specimens for Trichomonas vaginalis, antigen and nucleic acid detection. Each of them simulates a clinical specimen (vaginal discharge) and should therefore be handled with the same care as normal patient samples, capable of transmitting infectious disease. Store the specimens at 2 … 8 °C. Follow the standard operating procedure of your laboratory for disposal of the specimens. Handling instructions 1. The specimens are ready-to-use. 2. Let the specimens warm up to room temperature and mix well.

- Put a sample collection swab into the specimen tube, mix and let it absorb for 10 seconds.

- If the specimens should be diluted use the sample diluent supplied by your test kit. Use the same dilution ratio as instructed in your test kit’s instructions.

3. Prepare and test the specimens similar to patient samples according to the instructions of your test kit. Results Please enter the results and methods via LabScala. If you can’t find your instrument, reagent or test kit from the registry, please contact the EQA coordinator. LabScala instructions are found in “LabScala User instructions” on the top right-hand corner of LabScala web page. Additional results (max 3/specimen) may be reported, if the specimen volume is sufficient for the test kits in question. When multiple results are reported, only results reported for different test kits will be processed, not parallel results for the same kit. All reported results will be scored. Barcodes for the specimens S001: LQ769919021

S002: LQ769919022

S003: LQ769919023

2019-10-29 Instructions Product no. 5473 LQ769919021-023/CA The shipment includes - 3 specimens (à ~1 mL) If the kit is incomplete or contains damaged specimens, please report immediately to [email protected] Closing date Please return your results via LabScala no later than November 21, 2019. The expected results of the round are published in LabScala in the View reports section by November 26, 2019. Inquiries EQA Coordinator Elina Tuovinen +358 50 361 3571 [email protected] EQA Coordinator Jaana Paakkanen +358 50 362 7719 [email protected] Labquality Kumpulantie 15 FI-00520 Helsinki FINLAND

Telephone +358 9 8566 8200

Fax +358 9 8566 8280

[email protected] www.labquality.fi

Trichomonas vaginalis, antigen and nucleic acid detection,November, 2-2019

Copyright © Labquality Oy

13.12.2019 1/5

History Test nr. Own success rate Difference AVR success rateRound 2019-1 1-1 100 % 0 % 100 %

Summary Own score Max score Own success rate Difference AVR success rateSpecimen S001 2 2 100 % 0 % 100 %Specimen S002 2 2 100 % 0 % 100 %Specimen S003 2 2 100 % 0 % 100 %Average: 100 % 0 % 100 %

Client report

No of participants No of respondedparticipants

Response percentage

Trichomonas vaginalis, antigen and nucleic acid detection, November, 2-2019 29 29 100 %

Summary

xxxxx



13.12.2019 2/5

Specimen S001 |

Specimen S001 results Responded Own score Max score Own success rate Difference AVR success rate CountTrichomonas vaginalis NAT 2 2 100 % 0 % 100 % 24Trichomonas vaginalis Ag - - - - 100 % 6

Total: 2 2 100 % 0 % 100 % 30

OWN DEVICE: TRICH

Trichomonasvaginalis NAT

Interpretation Method Interpretationcount

Methodcount

Ownscore

Maxscore

Ownsuccess

rate

Difference AVRsuccess

rateNegative 24 2 2 100 % 0 % 100 %

Anyplex II STI-7 Detection, seegene 1Aptima T.vaginalis Assay, Hologic 3BD Max CT/NG/TV, BD 6BD Max Vaginal Panel, BD 3

BD ProbeTec TV Q Amplified DNAAssay, BD

2

Cobas TV/MG, Roche 2S-Dia MGTV, Diagenode Diagnostics 2Trichomonas vaginalis In House 1Xpert TV, Cepheid 4

Total: 24 2 2 100 % 0 % 100 %

Trichomonasvaginalis Ag


Methodcount

Ownscore

Maxscore

Ownsuccess

rate


rateNegative 6 100 %

OSOM Trichomonas Rapid Test(Sekisui)

6

Total: 6 - - - - 100 %

xxxxx



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Specimen S002 |

Specimen S002 results Responded Own score Max score Own success rate Difference AVR success rate CountTrichomonas vaginalis NAT 2 2 100 % 0 % 100 % 25Trichomonas vaginalis Ag - - - - 100 % 6Further action - - - - - 1

Total: 2 2 100 % 0 % 100 % 32

OWN DEVICE: TRICH



Methodcount

Ownscore

Maxscore

Ownsuccess

rate


ratePositive 24 2 2 100 % 0 % 100 %

Anyplex II STI-5 Detection, seegene 1Anyplex II STI-7 Detection, seegene 1Aptima T.vaginalis Assay, Hologic 3BD Max CT/NG/TV, BD 6BD Max Vaginal Panel, BD 2


2


Weak positive 1 100 %BD Max CT/NG/TV, BD 1

Total: 25 2 2 100 % 0 % 100 %



Methodcount

Ownscore

Maxscore

Ownsuccess

rate


ratePositive 3 100 %


3

Weak positive 3 100 %

xxxxx



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3

Total: 6 - - - - 100 %

Further action Response Response countT. vaginalis would be confirmed 1Total: 1

xxxxx



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Specimen S003 |

Specimen S003 results Responded Own score Max score Own success rate Difference AVR success rate CountTrichomonas vaginalis NAT 2 2 100 % 0 % 100 % 24Trichomonas vaginalis Ag - - - - 100 % 6

Total: 2 2 100 % 0 % 100 % 30

OWN DEVICE: TRICH



Methodcount

Ownscore

Maxscore

Ownsuccess

rate


ratePositive 24 2 2 100 % 0 % 100 %

Anyplex II STI-7 Detection, seegene 1Aptima T.vaginalis Assay, Hologic 3BD Max CT/NG/TV, BD 7BD Max Vaginal Panel, BD 2


2


Total: 24 2 2 100 % 0 % 100 %



Methodcount

Ownscore

Maxscore

Ownsuccess

rate


ratePositive 6 100 %


6

Total: 6 - - - - 100 %

xxxxx



13.12.2019 1/5

GLOBAL REPORT

No of participants No of respondedparticipants

Response percentage

Trichomonas vaginalis, antigen and nucleic acid detection, November, 2-2019 29 29 100 %

Summary

Summary AVR success rateSpecimen S001 100 %Specimen S002 100 %Specimen S003 100 %Average: 100 %



13.12.2019 2/5

Specimen S001 |

Specimen S001 results Responded AVR success rate CountTrichomonas vaginalis NAT 100 % 24Trichomonas vaginalis Ag 100 % 6

Total: 100 % 30



Methodcount

AVR successrate

InterpretationScore

Negative 24 100 % 2Anyplex II STI-7 Detection, seegene 1Aptima T.vaginalis Assay, Hologic 3BD Max CT/NG/TV, BD 6BD Max Vaginal Panel, BD 3BD ProbeTec TV Q Amplified DNA Assay,BD

2


Total: 24 100 %



Methodcount

AVR successrate

InterpretationScore

Negative 6 100 % 2OSOM Trichomonas Rapid Test (Sekisui) 6

Total: 6 100 %



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Specimen S002 |

Specimen S002 results Responded AVR success rate CountTrichomonas vaginalis NAT 100 % 25Trichomonas vaginalis Ag 100 % 6Further action - 1

Total: 100 % 32



Methodcount

AVR successrate

InterpretationScore

Positive 24 100 % 2Anyplex II STI-5 Detection, seegene 1Anyplex II STI-7 Detection, seegene 1Aptima T.vaginalis Assay, Hologic 3BD Max CT/NG/TV, BD 6BD Max Vaginal Panel, BD 2BD ProbeTec TV Q Amplified DNA Assay,BD

2


Weak positive 1 100 % 2BD Max CT/NG/TV, BD 1

Total: 25 100 %



Methodcount

AVR successrate

InterpretationScore

Positive 3 100 % 2OSOM Trichomonas Rapid Test (Sekisui) 3

Weak positive 3 100 % 2OSOM Trichomonas Rapid Test (Sekisui) 3

Total: 6 100 %



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Further action Response Response countT. vaginalis would be confirmed 1Total: 1



13.12.2019 5/5

Specimen S003 |

Specimen S003 results Responded AVR success rate CountTrichomonas vaginalis NAT 100 % 24Trichomonas vaginalis Ag 100 % 6

Total: 100 % 30



Methodcount

AVR successrate

InterpretationScore

Positive 24 100 % 2Anyplex II STI-7 Detection, seegene 1Aptima T.vaginalis Assay, Hologic 3BD Max CT/NG/TV, BD 7BD Max Vaginal Panel, BD 2BD ProbeTec TV Q Amplified DNA Assay,BD

2


Total: 24 100 %



Methodcount

AVR successrate

InterpretationScore

Positive 6 100 % 2OSOM Trichomonas Rapid Test (Sekisui) 6

Total: 6 100 %

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External Quality Assessment Scheme

Trichomonas vaginalis, antigen and nucleic acid detection Round 2, 2019 Specimens were sent to 29 laboratories located in six different countries. All laboratories returned their results.

Specimens The specimens were three liquid specimens for Trichomonas vaginalis antigen and nucleic acid detection. Each of them simulated a clinical vaginal discharge specimen (including human DNA). The specimens were distributed to the participants by mail without any temperature control. The instruction was to analyse the specimens as soon as possible, but within one week. The specimens should have been stored at 2…8 °C.’ Expected results

Specimen Trichomonas vaginalis

antigen detection Trichomonas vaginalis nucleic acid detection

S001 (LQ769919021) Negative Negative

S002 (LQ769919022) Positive/weak positive Positive

S003 (LQ769919023) Positive Positive

Based on the quality controls conducted by the sample material manufacturer and the results obtained in the round, the sample lots are to be considered as homogeneous, stable and suitable for external quality assessment.

Results The reports for this scheme are generated in LabScala. Choose report name on the left column of My report view in LabScala.

Accepted results are marked with green color and laboratory’s own result with a black radio button (). In the scoring section you can see summaries of overall success rate and sample-specific success rates (%). Sample-specific interpretations are shown in pie diagrams as percentages and the total interpretation and methodics counts in the tables. Please note that by default the distribution pies are closed in the scoring reports. You can open the distribution pies by clicking the screen button at the right end of the result distribution row.

If you have no results you will get a note: “You have not responded in time, only global report is available”.

For information on report interpretation and performance evaluation, please see the "EQAS Interpretation guidelines" in LabScala User instructions. In case you have any questions regarding the reports, please contact the EQA Coordinator. Comments Results of this round were excellent, as all participants reported the expected results. In the positive samples S002 and S003 there were different amounts of the target, S002 being deliberately weaker positive than S003. Even this had no effect on the performance in antigen nor PCR analysis.

2019-12-13

Final report Product no. 5473 LQ769919021-023/CA Items sent 2019-10-29 Round closed 2019-11-21 Expected results 2019-11-26 Final report 2019-12-13 The report contains Expected results, scheme expert comments, laboratory-specific result and scoring report Request for corrections Typing errors in laboratory’s result forms are on laboratory’s responsibility. Labquality accepts responsibility only for result processing. Requests must be notified by writing within three weeks from the date of this letter. Authorized by EQA Coordinator Jaana Paakkanen +358 50 362 7719 [email protected] EQA Coordinator Elina Tuovinen +358 50 361 3571 [email protected] Expert Taru Meri, University of Helsinki [email protected] Labquality Kumpulantie 15 FI-00520 HELSINKI

Telephone +358 9 8566 8200

Fax +358 9 8566 8280 [email protected] www.labquality.fi

© Labquality

mailto:[email protected]

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Background

Diagnosis of Trichomonas vaginalis has traditionally based on microscopical analysis from vaginal swabs. Antigen and nucleic acid detection tests have replaced or supplemented microscopical analysis. Molecular techniques such as polymerase chain reaction (PCR) and real-time PCR to detect Trichomonas vaginalis provide high sensitivity and specificity. Antigen tests are rapid to perform and can be done on site. Scoring Scoring is implemented for each test or specimen when 60% or more of the participants report a correct result. The scoring range is 0-2 points and the following general rules are followed:

- Correct/expected test result 2/2 p. - False/deviating test result 0/2 p.

Exceptions: - Laboratory’s scores have been converted to percentage (own success rate, % from maximum scores) with a target at 100%. Own success rate is compared with the success rate of all results.

End of report

Copyright © Labquality Oy. Labquality does not permit any reproduction for commercial purposes of any portion of the material subject to this copyright. Labquality prohibits any use of its name, or reference to Labquality EQA program, or material in this report in any advertising, brochures or other commercial publications. Labquality EQA data do not necessarily indicate the superiority of instruments, reagents, testing equipment or materials used by participating laboratories. Use of Labquality EQA data to suggest superiority or inferiority of equipment or materials may be deceptive and misleading. Proficiency test results are handled confidentially. Labquality will not issue any statements to third parties of the performance of laboratories in external quality assessment schemes unless otherwise agreed.

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Trichomonas vaginalis, antigen and nucleic acid detection