m-PIMA HIV- 1/2 Viral Load

m-PIMA HIV- 1/2 Viral Load Data

Below are a tabled sheet and graphical representation of the data for this product. Use the filters below to sort the data by author, year, and/or country. The sheet and graphs are defaulted to show the first ten entries, but you can use the provided dropdown and paging buttons on the Data Summaries Sheet tab to view more entries. In the Data Summaries Sheet box below, there are buttons to export the full or filtered data as simple text in various formats.

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Author(s):

Publication year:

Country:

wdt_ID	Author(s)	Publication year	Publication type	Type of study	Country	Study period	Intervention (assay)	Comparator (assay)	Sample Type	Sample size (number of specimens analyzed)	Study setting	Patient/study population	Where sample was collected	Where sample was tested	Device users/operators, type and number (if available)	Concordance or agreement	Concordance or agreement	Bland Altman's mean of difference (log copies per ml)	Sensitivity	Sensitivity	Specificity	Specificity	Error/failure rate	Error/failure rate	Citation
	Author(s)	Publication year			Country

nr/nd = not reported/no data

Only data points, indicated in the legend, have been plotted. To review additional performance evaluation data by author(s) and study, see the Data Summaries Sheet tab.

m-PIMA HIV-1/2 Viral Load Test is a quantitative in vitro nucleic acid amplification test designed for the quantification of HIV type 1 and type 2 RNA in human plasma specimens from individuals with diagnosed HIV-1 or HIV-2 infection.

Manufacturer: Alere Technologies GmbH (now Abbott)

Manufacturer Location: Lake Bluff, IL (USA)

Instrument compatibility: m-PIMA Analyser

Detects: HIV-1 and HIV-2

Quality Standards: WHO PQ; CE marked

WHO Reference Number: PQ Dx 0359-032-00

WHO Listing Date: 8 April 2019

View Intended Use Summarised Results from WHO Prequalification

Diagnostic Product Data

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Data Summaries Sheet Performance Data Graph Error/Failure Rate Graph

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Author(s):

Publication year:

Country:

wdt_ID	Author(s)	Publication year	Publication type	Type of study	Country	Study period	Intervention (assay)	Comparator (assay)	Sample Type	Sample size (number of specimens analyzed)	Study setting	Patient/study population	Where sample was collected	Where sample was tested	Device users/operators, type and number (if available)	Concordance or agreement	Concordance or agreement	Bland Altman's mean of difference (log copies per ml)	Sensitivity	Sensitivity	Specificity	Specificity	Error/failure rate	Error/failure rate	Citation
	Author(s)	Publication year			Country

nr/nd = not reported/no data

Intended Use*

To be used in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 and HIV-2 infected patients
To be used by trained health care or laboratory professionals or other health care workers receiving appropriate training
Suitable for laboratory and non-laboratory environments and for near-patient testing
Not intended as a diagnostic test to confirm the presence of HIV-1 and HIV-2 infection or as a donor screening test for HIV

*based upon manufacturer's instructions

Summarized results from WHO prequalification
Evaluator	NHLS Haematology and HIV Molecular Laboratory, Charlotte Maxeke Johannesburg Academic Hospital on behalf of WHO
Evaluation period	August 2018 – February 2019
Reference standard	Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0
Specimen type	Plasma
Number of specimens	421 specimens: 122 not detected, 52 detected <1000 cp/mL and 247 >1000 cp/mL
Correlation	R² =0.933, P<0.0001
Mean Bias	-0.2109 log10 cp/mL and limits of agreement of -0.6029 log10 cp/mL to 0.1810 log10 cp/mL compared to the reference standard.
Sensitivity at threshold of 1000 cp/ml	95.1% (95% CI: 91.7; 97.5)`
Specificity at threshold of 1000 cp/ml	99.4% (95% CI: 96,8; 99.99)
Invalid Rate	9.2%
Limits of detection	For HIV-1: 314 (CI 95%, 219- 617) cp/mL For HIV-2: 432 (CI 95%, 305 – 867) cp/mL
Carryover*	0%

Source: WHO PQ Public Report (Sept 2019, v2)

* Carryover refers to the phenomenon whereby part of an analyte present in a sample appears to be present in the next or adjacent sample that is subject to the same analytic process.

m-PIMA HIV- 1/2 Viral Load Data

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Intended Use*