Evidence map›Paper›PMID 34558082›Full record

Observational studyVox sanguinis2022

Evaluation of the Sysmex XN-31 automated analyser for blood donor malaria screening at Malawi Blood Transfusion Services.

Bridon M'baya, Thom Mfune, Aubrey Samon, Talent Hwandih, Marion Münster

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Vox sanguinis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
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  8. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Bridon M'bayaMalawi Blood Transfusion Service, Blantyre, Malawi.
Thom MfuneMalawi Blood Transfusion Service, Blantyre, Malawi.
Aubrey SamonMalawi Blood Transfusion Service, Blantyre, Malawi.
Talent HwandihSysmex Europe, Norderstedt, Germany.
Marion MünsterSysmex Europe, Norderstedt, Germany.ORCID https://orcid.org/0000-0002-5366-4842
Malawi Blood Transfusion Service · MWSysmex (Germany) · DE

Funding

Sysmex Europe funded the study and provided the XN-31 analyser and related reagents for the study duration
6 · The paper itself

Abstract

BACKGROUND AND

objectivesBalancing blood supply safety and sufficiency is challenging in malaria-endemic countries where the risk of transfusion-transmitted malaria (TTM) is ever-present. In support of reducing this risk, our study aimed at evaluating the performance of the Sysmex XN-31 analyser in blood donor malaria screening, as compared with current practice in Malawi. MATERIALS AND

methodsThis prospective observational study was conducted on remnant venous donor blood samples collected at Malawi Blood Transfusion Service donation sites countrywide for routine blood-borne pathogen screening. XN-31 results were compared with routine thick smear malaria microscopy, using expert microscopy (phase 1 and 2) plus qualitative malaria polymerase chain reaction (PCR) (phase 2) to adjudicate discrepancies.

resultsXN-31 detected malaria in 614 (11.6%) of 5281 study samples compared with 341 (6.5%) for routine microscopy. Of the 273 discrepant samples, 60 smears (phase 1) could not be retrieved for expert microscopic review. Expert microscopy confirmed the XN-31 positivity in 78.8% (149/189) and 91.7% (22/24) of discrepant samples in phase 1 (n = 4416) and phase 2 (n = 975), respectively, with two cases requiring PCR testing, confirming one each as positive and negative, giving sensitivities of 100% and 75% and specificities of 99.9% and 100%, respectively, for XN-31 and routine microscopy.

conclusionThe automated Sysmex XN-31 analyser's high sensitivity and specificity, ability to detect all Plasmodium species and high throughput with rapid turnaround-time, overcomes many of the limitations of currently available diagnostic tests, making it well-suited for malaria screening of donated blood in malaria-endemic countries in support of TTM risk reduction.

Indexed as

Blood DonorsMalariaBlood SafetyBlood TransfusionHumansMalawiblood donation testingblood safetyhigh throughput testingmalaria and protozoal infectionspatient blood managementtransfusion-transmissible infections

Identifiers

PMID34558082
PMCPMC9290921
OpenAlexW3201238588

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.