← Product Code [MZF](/productcode/MZF) · BK241116

# LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT (BK241116)

_DiaSorin, Inc. Stillwater, MN · MZF · Jun 10, 2025 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/BK241116

## Device Facts

- **Applicant:** DiaSorin, Inc. Stillwater, MN
- **Product Code:** [MZF](/productcode/MZF.md)
- **Decision Date:** Jun 10, 2025
- **Decision:** SESE
- **Regulation:** 21 CFR 866.3956
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** Pediatric

## Indications for Use

The LIAISON® MUREX HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum (without or with gel-SST) or plasma (lithium and sodium heparin, sodium citrate, and potassium EDTA), on the LIAISON® XL Analyzer or LIAISON® XS Analyzer. It is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (2-21 years) and in pregnant women. The assay cannot distinguish between the detection of HIV p24 antigen and HIV-1/HIV-2 antibodies. The LIAISON® MUREX HIV Ab/Ag HT assay is not intended for screening donors of blood or blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV. The LIAISON® MUREX Control HIV Ab/Ag HT is intended for use as assayed quality control samples to monitor the performance of the LIAISON® MUREX HIV Ab/Ag HT assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL and LIAISON® XS.

## Device Story

In vitro chemiluminescent immunoassay (CLIA) for simultaneous qualitative detection of HIV p24 antigen and HIV-1/HIV-2 antibodies; utilizes automated LIAISON® XL or LIAISON® XS analyzers. Input: human serum or plasma samples. Process: automated dispensing of magnetic particles, conjugate, and starter reagents into reaction cuvettes; incubation; washing; light emission measurement via photomultiplier. Output: Signal/Cut-off (S/CO) ratio. Used in clinical laboratories; operated by trained technicians. Output aids healthcare providers in diagnosing HIV-1/HIV-2 infection, including acute/primary cases. Benefits include rapid, automated, standardized diagnostic testing for pediatric and pregnant populations.

## Clinical Evidence

No new clinical studies performed. Evidence consists of non-clinical performance testing: analytical sensitivity (seroconversion panels, WHO reference standards), method comparison (n=355 specimens across 3 sites, PPA 97.8%, NPA 97.7%), 20-day precision, 5-day reproducibility, calibration stability, and carryover studies. Results demonstrate equivalence between LIAISON® XS and LIAISON® XL platforms.

## Technological Characteristics

Chemiluminescent immunoassay (CLIA); automated processing; photomultiplier detection. Reagents: magnetic particles, calibrators, assay buffer, conjugate. Sample types: serum/plasma. Cut-off: 1.00 S/CO. Connectivity: LIAISON® XL (freestanding) and LIAISON® XS (benchtop) analyzers. Storage: 2-8°C. Software: automated analysis of light emission signals.

## Regulatory Identification

Human immunodeficiency virus (HIV) serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues. The tests are intended for use as an aid in the diagnosis of infection with HIV and are for professional use only. The test results are intended to be interpreted in conjunction with other relevant clinical and laboratory findings. These tests are not intended to be used for monitoring patient status, or for screening donors of blood or blood products, or human cells, tissues, and cellular and tissue-based products (HCT/Ps).

## Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) For all HIV serological diagnostic and supplemental tests
(i) The labeling must include:
(A) An intended use that states that the device is not intended for use for screening donors of blood or blood products or HCT/Ps.
(B) A detailed explanation of the principles of operation and procedures used for performing the assay.
(C) A detailed explanation of the interpretation of results and recommended actions to take based on results.
(D) Limitations, which must be updated to reflect current clinical practice and disease presentation and management. The limitations must include, but are not limited to, statements that indicate:
(
*1* ) The matrices with which the device has been cleared, and that use of this test kit with specimen types other than those specifically cleared for this device may result in inaccurate test results.(
*2* ) The test is not intended to be used to monitor individuals who are undergoing treatment for HIV infection.(
*3* ) A specimen with a reactive result should be investigated further following current guidelines.(
*4* ) All test results should be interpreted in conjunction with the individual's clinical presentation, history, and other laboratory results.(
*5* ) A test result that is nonreactive does not exclude the possibility of exposure to or infection with HIV. Nonreactive results in this assay may be due to analyte levels that are below the limit of detection of this assay.(ii) Device verification and validation must include:
(A) Detailed device description, including the device components, ancillary reagents required but not provided, and an explanation of the methodology. Additional information appropriate to the technology must be included, such as the amino acid sequence of antigen(s) and design of capture antibodies.
(B) For devices with assay calibrators, the design of all primary, secondary, and subsequent quantitation standards used for calibration as well as their traceability to a reference material. In addition, analytical testing must be performed following the release of a new lot of the standard material that was used for device clearance, or when there is a transition to a new calibration standard.
(C) Detailed documentation of analytical performance studies conducted as appropriate to the technology, specimen types tested, and intended use of the device, including, but not limited to, limit of blank, limit of detection, cutoff determination, precision, endogenous and exogenous interferences, cross reactivity, carryover, quality control, matrix equivalency, and sample and reagent stability. Samples selected for use in analytical studies or used to prepare samples for use in analytical studies must be from subjects with clinically relevant circulating genotypes in the United States.
(D) Multisite reproducibility study that includes the testing of three independent production lots.
(E) Analytical sensitivity of the test must be the same as or better than that of other cleared or approved tests. Samples tested must include appropriate numbers and types of samples, including real clinical samples near the lower limit of detection. Analytical specificity of the test must be the same as or better than that of other cleared or approved tests. Samples must include appropriate numbers and types of samples from patients with different underlying illnesses or infections and from patients with potential endogenous interfering substances.
(F) Detailed documentation of performance from a multisite clinical study. Performance must be analyzed relative to an FDA-cleared or approved comparator. This study must be conducted using patient samples, with an appropriate number of HIV positive and HIV negative samples in applicable risk categories. Additional subgroups or types must be validated using appropriate numbers and types of samples. The samples may be a combination of fresh and repository samples, sourced from within and outside the United States, as appropriate. The study designs, including number of samples tested, must be sufficient to meet the following criteria:
(
*1* ) Clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 99 percent.(
*2* ) Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 99 percent.(G) Strategies for detection of new strains, types, subtypes, genotypes, and genetic mutations as they emerge.
(H) Risk analysis and management strategies, such as Failure Modes Effects Analysis and/or Hazard Analysis and Critical Control Points summaries and their impact on test performance.
(I) Final release criteria to be used for manufactured test lots with appropriate evidence that lots released at the extremes of the specifications will meet the claimed analytical and clinical performance characteristics as well as the stability claims.
(J) All stability protocols, including acceptance criteria.
(K) Appropriate and acceptable procedure(s) for evaluating customer complaints and other device information that determines when to submit a medical device report.
(L) Premarket notification submissions must include the information contained in paragraph (b)(1)(ii)(A) through (K) of this section.
(iii) Manufacturers must submit a log of all complaints. The log must include the following information regarding each complaint if available: The type of event (
*e.g.,* false negative/false nonreactive or false positive/false reactive), lot, date, population, and whether or not the complaint was reported under part 803 of this chapter (Medical Device Reporting). The log must be submitted annually on the anniversary of clearance for 5 years following clearance of a traditional premarket notification.(2) If the test is intended for Point of Care (PoC) use, the following special controls, in addition to those listed in paragraph (b)(1) of this section apply:
(i) The PoC labeling must include a statement that the test is intended for PoC use.
(ii) The PoC labeling must include the following information near the statement of the intended use:
(A) That the test is for distribution to clinical laboratories that have an adequate quality assurance program, including planned systematic activities that provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional materials.
(B) That the test is for use only by an agent of a clinical laboratory.
(C) Instructions for individuals to receive the “Subject Information Notice” prior to specimen collection and appropriate information when test results are provided.
(iii) PoC labeling must include instructions to follow current guidelines for informing the individual of the test result and its interpretation.
(iv) The instructions in the labeling must state that reactive results are considered preliminary and should be confirmed following current guidelines.
(v) Device verification and validation for PoC use must include:
(A) Detailed documentation of performance from a multisite clinical study conducted at appropriate PoC sites. Performance must be analyzed relative to an FDA cleared or approved comparator. This study must be conducted using patient samples, with appropriate numbers of HIV positive and HIV negative samples in applicable risk categories. Additional subgroup or type claims must be validated using appropriate numbers and types of samples. The samples may be a combination of fresh and repository samples, sourced from within and outside the United States, as appropriate. If the test is intended solely for PoC use, the test must meet only the performance criteria in paragraphs (b)(2)(v)(A)(
*1* ) and (*2* ) of this section and not the criteria in paragraph (b)(1)(ii)(F) of this section:(
*1* ) Clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 98 percent.(
*2* ) Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 98 percent.(B) Premarket notification submissions must include the information contained in paragraph (b)(2)(v)(A) of this section.
(3) If the test is intended for supplemental use in addition to use as an aid in initial diagnosis, the following special controls, in addition to those listed in paragraphs (b)(1) and (2) of this section, as appropriate, apply:
(i) The labeling must include a statement that the test is intended for use as an additional test to confirm the presence of HIV antibodies or antigens in specimens found to be repeatedly reactive by a diagnostic screening test.
(ii) Device validation and verification for supplemental use must include a clinical study, including samples that were initially reactive and repeatedly reactive on a diagnostic test but were negative or indeterminate on a different confirmatory test. Premarket notification submissions must include this information.
(4) If the test is intended solely as a supplemental test, the following special controls, in addition to those listed in paragraphs (b)(1) and (2) of this section, except those in paragraphs (b)(1)(ii)(F) and (b)(2)(v)(A) of this section, as appropriate, apply:
(i) The labeling must include a statement that the test is intended for use as an additional test to confirm the presence of HIV antibodies or antigens in specimens found to be repeatedly reactive by a diagnostic screening test.
(ii) The labeling must clearly state that the test is not for use for initial diagnosis or is not intended as a first-line test.
(iii) Device validation and verification must include a clinical study including samples that were initially reactive and repeatedly reactive on a diagnostic test but were negative or indeterminate on a confirmatory test. Premarket notification submissions must include this information.
(5) If the test is intended to differentiate different HIV types, the following special controls, in addition to those listed in paragraphs (b)(1) through (4) of this section, as appropriate, apply:
(i) The labeling must include the statement that the test is intended for the confirmation of initial results from a diagnostic test and differentiation of different HIV types.
(ii) The results interpretation in the labeling must include instructions for the user on how to interpret the results, including un-typeable and co-infection results.
(iii) Device validation and verification must include evaluation of analytical and clinical sensitivity and specificity for each of the HIV types, strains, and subtypes of HIV intended to be differentiated. Premarket notification submissions must include this information.

## Predicate Devices

- LIAISON® XL MUREX HIV Ab/Ag HT (BP190437)
- LIAISON® XL MUREX Control HIV Ab/Ag HT (BP190437)

## Submission Summary (Full Text)

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Diasorin
The Diagnostic Specialist

LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT

# 510(k) SUMMARY

SUBMITTED BY:

Carly Cook
Specialist I, Regulatory Affairs
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Email: carly.cook@diasorin.com

NAME OF DEVICE:

Trade Name:

LIAISON® MUREX HIV Ab-Ag HT
LIAISON® MUREX Control HIV Ab-Ag HT

Common Names/Description: HIV Ab-Ag Assay and HIV Ab-Ag Control

Classification:

Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test: 21 CFR 866.3956; Class II (performance standards); Microbiology (83)
Quality Control Material: 21 CFR 862.1660; Class I;

Product Code:

MZF

PREDICATE DEVICE: LIAISON® XL MUREX HIV Ab/Ag HT; LIAISON® XL MUREX Control HIV Ab/Ag HT (BP190437)

DEVICE DESCRIPTION:

The LIAISON® MUREX HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum or plasma.

For In Vitro Diagnostic Use.

For Prescription Use Only.

The LIAISON® MUREX Control HIV Ab/Ag HT set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® MUREX HIV Ab/Ag HT assay.

The assay and controls are designed for use with the DiaSorin LIAISON® XL and LIAISON® XS.

INTENDED USE(s):

The LIAISON® MUREX HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum (without or with gel-SST) or plasma (lithium and sodium heparin, sodium citrate, and potassium EDTA), on the LIAISON® XL Analyzer or LIAISON® XS Analyzer. It is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (2-21 years) and in pregnant women.

The assay cannot distinguish between the detection of HIV p24 antigen and HIV-1/HIV-2 antibodies.

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LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT---

The LIAISON® MUREX HIV Ab/Ag HT assay is not intended for screening donors of blood or blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV.

The LIAISON® MUREX Control HIV Ab/Ag HT is intended for use as assayed quality control samples to monitor the performance of the LIAISON® MUREX HIV Ab/Ag HT assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL and LIAISON® XS.

# COMPARISON TO THE PREDICATE (Description of the Modifications to the Legally Marketed Device):

Modifications to the DiaSorin LIAISON® XL MUREX HIV Ab/Ag HT assay include:

- Addition of LIAISON® XS Analyzer

The following tables provide a summary of the similarities and differences between the FDA cleared LIAISON® XL MUREX HIV Ab/Ag HT, LIAISON® XL MUREX Control HIV Ab/Ag HT and the modified devices.

|  Table of Similarities LIAISON® MUREX HIV Ab/Ag HT  |   |   |
| --- | --- | --- |
|  Characteristic | Predicate Device DiaSorin LIAISON® XL MUREX HIV Ab/Ag HT BP190437, approved 11/25/2020 | Modified Device DiaSorin LIAISON® MUREX HIV Ab/Ag HT  |
|  Technology/ Assay Principle | Chemiluminescent Immunoassay (CLIA) | Same  |
|  Sample Handling/Assay Processing | Automated | Same  |
|  Manufacturing Process | No Change | Same  |
|  Storage | Store at 2-8° C until ready to use | Same  |
|  Measured Analyte | HIV p24 antigen and antibodies to HIV-1 and HIV-2 | Same  |
|  Sample Volume | 350 µL specimen (200 µL specimen + 150 µL dead volume) | Same  |
|  Assay Procedure | - Dispense calibrators, controls or specimens into the reaction cuvettes. - Dispense coated magnetic particles. - Dispense Assay Buffer. - Incubate. - Wash with Wash/System liquid. - Dispense Conjugate into the reaction cuvettes. - Incubate. - Wash with Wash/System liquid. - Add the Starter Reagents and measure the light emitted. | Same  |

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The Diagnostic Specialist

LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT

|  |   |   |
| --- | --- | --- |
|  Measurement System | Photomultiplier (flash chemiluminescence reader) | Same  |
|  Calibrators | Included with kit | Same  |
|  Open Use/On Board Stability | Five (5) weeks when stored at 2–8°C or on board the analyzer. | Same  |
|  Calibration Stability | Five (5) weeks | Same  |
|  Controls | Provided Separately | Same  |
|  Sample Storage at 2-8°C | If the assay is performed within seven (7) days of sample collection, the samples may be kept at 2–8°C | Same  |
|  Serum Storage Freeze-Thaw Cycles | Samples are stable through seven (7) freeze/thaw cycles | Same  |
|  Reagent Integral Configuration and Volume Provided | • Magnetic particles – 1 compartment (2.5 mL) • Calibrator – 1 compartment (2.9 mL) • Assay buffer – 1 compartment (10.8 mL) • Conjugate – 2 compartments (23 mL each compartment) | Same  |
|  Raw materials |  |   |
|  Sample Type | Human Serum or Plasma | Same  |
|  Tests per Kit | 200 | Same  |
|  Cut-Off | 1.00 S/CO | Same  |
|  Calibration | Calibration by using fully qualitative approach | Same  |
|  Unit of Measure | Signal/Cut-off (S/CO) | Same  |

|  Table of Differences LIAISON® MUREX HIV Ab/Ag HT  |   |   |
| --- | --- | --- |
|  Characteristic | Predicate Device DiaSorin LIAISON® XL MUREX HIV Ab/Ag HT BP190437, approved 11/25/2020 | Modified Device DiaSorin LIAISON® MUREX HIV Ab/Ag HT  |
|  Intended Use/Indications for Use | The LIAISON® XL MUREX HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human adult and pediatric (2 – 21 years) serum or plasma (lithium and sodium heparin, sodium citrate and potassium EDTA) including separator tubes, on the LIAISON® XL Analyzer. | The LIAISON® MUREX HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum (without or with gel-SST) or plasma (lithium and sodium heparin, sodium citrate, and potassium EDTA), on the LIAISON® XL Analyzer or LIAISON® XS Analyzer.  |

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LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT

|   | It is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects and in pregnant women. The assay cannot distinguish between the detection of HIV antigen and HIV-1/HIV-2 antibodies. The LIAISON® XL MUREX HIV Ab/Ag HT assay is not intended for the screening blood, blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV. | It is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (2-21 years) and in pregnant women. The assay cannot distinguish between the detection of HIV p24 antigen and HIV-1/HIV-2 antibodies. The LIAISON® MUREX HIV Ab/Ag HT assay is not intended for screening donors of blood or blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps), or organ donors for HIV.  |
| --- | --- | --- |
|  Instrument Platform | LIAISON® XL (Free standing) | LIAISON® XL (Free standing) and LIAISON® XS (Benchtop)  |

**Table of Similarities and Differences LIAISON® MUREX Control HIV Ab/Ag HT**

|  Characteristic | Predicate Device DiaSorin LIAISON® XL MUREX Control HIV Ab/Ag HT BP190437, approved 11/25/2020 | Modified Device DiaSorin LIAISON® MUREX Control HIV Ab/Ag HT  |
| --- | --- | --- |
|  Intended Use | The LIAISON® XL MUREX Control HIV Ab/Ag HT is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL HIV Ab/Ag HT assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL. | The LIAISON® MUREX Control HIV Ab/Ag HT is intended for use as assayed quality control samples to monitor the performance of the LIAISON® MUREX HIV Ab/Ag HT assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL and LIAISON® XS.  |
|  Negative Control | Human serum non-reactive for HIV antigens and antibodies, 0.2% ProClin™ 300, preservatives. | Same  |
|  POSITIVE CONTROL (anti-HIV-2) | Human serum/plasma reactive for HIV-2 antibodies, 0.2% ProClin™ 300, preservatives. | Same  |
|  POSITIVE CONTROL (anti-HIV-1O) | Rabbit polyclonal reactive for HIV-1O antibodies, human serum, 0.2% ProClin™ 300, preservatives. | Same  |
|  POSITIVE CONTROL (anti-HIV-1M) | Human serum/plasma reactive for HIV-1M antibodies, 0.2% ProClin™ 300, preservatives. | Same  |

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The Diagnostic Specialist

LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT

|  POSITIVE CONTROL (HIV/Ag) | HIV p24 recombinant antigen (obtained in E.coli), stabilized in PBS buffer, bovine aprotinin, casein, 0.2% ProClin™ 300. | Same  |
| --- | --- | --- |
|  Reagent Configuration | 1 vial of each level, 4.5 mL/vial, ready to use. | Same  |
|  Storage | Store at 2-8° C until ready to use | Same  |
|  Open Use Stability | After removing the seals, the control vial is stable for nine (9) weeks when stored upright at 2–8°C. | Same  |

# SUMMARY OF PERFORMANCE DATA:

A summary of nonclinical performance testing associated with the DiaSorin LIAISON® MUREX HIV Ab/Ag HT assay on the LIAISON XS Analyzer is as follows:

# 1. Analytical Sensitivity: Seroconversion Panel

The purpose of the analytical sensitivity testing was to define the limits of an assay at low concentrations.

Analytical sensitivity testing was carried out with one (1) kit lot on one (1) LIAISON® XS unit and one (1) LIAISON® XL unit. It was evaluated by testing twenty (20) seroconversion panels across the two platforms which had previously been tested for the LIAISON® XL original PMA BP190437. Note: one (1) panel had not been previously tested but was run as no other panel from the PMA was available for procurement. The seroconversion samples were tested in singlicate, and controls (LIAISON® MUREX Control HIV Ab/Ag HT) used to validate the days' runs. The results were compared with information reported in Certificate of Analysis.

All twenty (20) seroconversion panels gave comparable results on the LIAISON® XS compared to the LIAISON® XL and matched the competitor assay from the CoA. The seroconversion sensitivity study demonstrated no discrepant results for the DiaSorin LIAISON® MUREX HIV Ab/Ag HT assay on the LIAISON® XS Analyzer versus the LIAISON® XL Analyzer.

# 2. Analytical Sensitivity: Detectable Concentration at Cut-off Level

The analytical sensitivity representing the cut-off dose in term of IU/ml, was evaluated by testing the WHO International Standard HIV-1 p24 Antigen, 1st International Reference Reagent (NIBSC code: 22/230).

The testing was carried out with one (1) kit lot on two (2) LIAISON® XS units. The analytical sensitivity of the assay was evaluated using serial dilutions of the WHO International Standard HIV-1 p24 Antigen, 1st International Reference Reagent (NIBSC code: 22/230) in both serum and plasma.

Results obtained were analyzed by linear regression analysis: the cut-off dose was identified as the dose corresponding to S/CO = 1.00 on the regression line; the final sensitivity value corresponded to the overall mean value.

The analytical sensitivity in terms of IU/mL, when the S/CO = 1.00, has been calculated for serum on one (1) LIAISON® XS as 1.170 IU/mL and on the other LIAISON® XS as 1.132 IU/mL. For plasma, the analytical sensitivity has been calculated on one (1) LIAISON® XS as 1.154 IU/mL and on the other LIAISON® XS as 1.086 IU/mL. These results demonstrated comparable analytical sensitivity performance to the LIAISON® XL.

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Diasorin
The Diagnostic Specialist

LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT

### 3. Method Comparison

A total of 355 specimens were analyzed for method comparison. Of these 355 specimens, 271 were native serum or plasma specimens and 84 samples were contrived to obtain antibody and/or antigen levels near the cut-off. To contrive the samples, either a unique negative specimen or a pool of unique negative specimens was blended with one (1) unique positive specimen per negative sample. Contrived samples (including the spiker or base units) were not included as neat samples in the method comparison.

Method comparison specimens were randomly divided across three (3) testing sites with equal numbers of samples per site for testing by the candidate device (LIAISON® MUREX HIV Ab/Ag HT assay on LIAISON® XS). Specimens were tested per the Instructions for Use (IFU) in a single replicate at each of the three (3) sites over a minimum of three (3) days by at least two (2) operators at each site. The specimens were also tested in a single replicate by the LIAISON® MUREX HIV Ab/Ag HT assay on the LIAISON® XL Analyzer, according to the IFU, internally (DSU laboratory) for comparison.

Overall Method Agreement

|  LIAISON® XS | All Sites combined | LIAISON® XL  |   |   |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  NR (n) | IR (n) | RR (n) | Total  |
|   |  NR | 125 | 8 | 5 | 130  |
|   |  IR | 4 | 222 | 3* | 224  |
|   |  RR | 3 | 5 | 220 | 225  |
|   |  Total | 128 | 230 | 225 | 355  |

*Two specimens were excluded from the final calculation as they were IR but QNS for repeat testing confirmation.

$$\mathbf{PPA} = (220/225) \ 97.8\% \ (95\% \ CI \ 94.9\% - 99.0\%)$$

$$\mathbf{NPA} = (125/128) \ 97.7\% \ (95\% \ CI \ 93.3\% - 99.2\%)$$

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LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT---

# **DSU Site Method Agreement**

|  LIAISON® MUREX HIV Ab/Ag HT Site: DSU | LIAISON® XL |   | Total  |   |
| --- | --- | --- | --- | --- |
|   |   |  RR |   | NEG  |
|  LIAISON® XS | RR | 77 | 2 | 79  |
|   |  NEG | 0 | 43 | 43  |
|   | Total | 77 | 45 | 122  |

PPA 100% (77/77) 95% CI (95.2%-100.0%)

NPA 95.6% (43/45) 95% CI (85.2%-98.8%)

# **KMI Site Method Agreement**

|  LIAISON® MUREX HIV Ab/Ag HT Site: KMI | LIAISON® XL |   | Total  |   |
| --- | --- | --- | --- | --- |
|   |   |  RR |   | NEG  |
|  LIAISON® XS | RR | 66 | 1 | 67  |
|   |  NEG | 1 | 47 | 48  |
|   | Total | 67 | 48 | 115  |

PPA 98.5% (66/67) 95% CI (92.0%-99.7%)

NPA 97.9% (47/48) 95% CI (89.1%-99.6%)

# **Pan Site Method Comparison**

|  LIAISON® MUREX HIV Ab/Ag HT Site: Pan | LIAISON® XL |   | Total  |   |
| --- | --- | --- | --- | --- |
|   |   |  RR |   | NEG  |
|  LIAISON® XS | RR | 77 | 0 | 77  |
|   |  NEG | 4 | 35 | 39  |
|   | Total | 81 | 35 | 116  |

PPA 95.1% (77/81) 95% CI (88.0%-98.1%)

NPA 100% (35/35) 95% CI (90.1%-100.0%)

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**Diasorin**^{}[] The Diagnostic Specialist

LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT

# **Summary of Discordant Samples**

|  Sample ID | LIAISON® XL |   | LIAISON® XS  |   |   |
| --- | --- | --- | --- | --- | --- |
|   |  Dose (S/CO) | Final Call | Dose (S/CO) | Final Call | Site  |
|  6.7459BCO | 0.967 | NR | 1.19, 1.19, 1.16 | RR | DSU  |
|  6.7471BCO | 0.921 | NR | 1.09, 1.07, 1.01 | RR | KMI  |
|  6.8076ACO | 0.794 | NR | 1.06, 1.08, 1.05 | RR | DSU  |
|  6.7474BCO | 1.28, 1.29, 1.14 | RR | 0.917 | NR | Pan  |
|  6.7478BCO | 1.23, 1.21, 1.19 | RR | 0.940 | NR | Pan  |
|  6.7485BCO | 1.17, 1.23, 1.17 | RR | 0.938 | NR | Pan  |
|  6.8075ACO | 1.02, 1.00, 0.916 | RR | 0.715 | NR | Pan  |
|  6.8271BCO | 1.10, 1.03, 1.07 | RR | 0.981 | NR | KMI  |

# **4. 20 Day Precision**

Precision testing was carried out on two (2) LIAISON® XS units, using two (2) LIAISON® MUREX HIV Ab/Ag HT (318290) kit lots, a different kit lot was used on each analyzer.

The precision of LIAISON® XL Murex HIV Ab/Ag HT US (318290) on the LIAISON® XS was evaluated using two (2) integral lots and two (2) LIAISON® XS instruments. LIAISON® XL Murex Control HIV Ab/Ag HT US (318291) and a panel of in-house made samples were tested in duplicate, two (2) runs a day, for twenty (20) days. Three samples for each of the four HIV subtypes were evaluated. The within lab precision obtained on the LIAISON® XS was comparable to that on the LIAISON® XL.

Within lab precision study results:

|  Sample | Mean Dose (S/CO) | N | Repeatability |   | Between-Run |   | Between Day |   | Between-Lot |   | Within-Lab  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV  |
|  #71330036 | 2.56 | 160 | 0.042 | 1.65% | 0.040 | 1.56% | 0.034 | 1.32% | 0.30 | 11.8% | 0.224 | 8.75%  |
|  #71340036 | 2.28 | 160 | 0.043 | 1.88% | 0.033 | 1.46% | 0.044 | 1.91% | 0.50 | 21.7% | 0.359 | 15.7%  |
|  #71350036 | 2.78 | 160 | 0.058 | 2.10% | 0.051 | 1.83% | 0.026 | 0.94% | 0.15 | 5.38% | 0.134 | 4.81%  |
|  #71360036 | 3.15 | 160 | 0.050 | 1.58% | 0.027 | 0.85% | 0.036 | 1.14% | 0.20 | 6.21% | 0.154 | 4.88%  |
|  #71370036 | 0.20 | 160 | 0.009 | 4.39% | 0.005 | 2.41% | 0.009 | 4.46% | 0.03 | 12.7% | 0.023 | 11.2%  |
|  HIV3U01 HIV-1 M Ab, high neg | 0.87 | 160 | 0.021 | 2.41% | 0.012 | 1.38% | 0.013 | 1.49% | 0.19 | 21.8% | 0.137 | 15.8%  |
|  HIV3U02 HIV-1 M Ab, low pos | 1.57 | 160 | 0.032 | 2.02% | 0.023 | 1.48% | 0.029 | 1.86% | 0.36 | 23.2% | 0.263 | 16.7%  |
|  HIV3U03 HIV-2 Ab, high neg | 0.84 | 160 | 0.020 | 2.43% | 0.006 | 0.70% | 0.016 | 1.88% | 0.02 | 2.78% | 0.031 | 3.70%  |
|  HIV3U04 HIV-2 Ab, low pos | 1.33 | 160 | 0.026 | 1.96% | 0.013 | 0.96% | 0.019 | 1.44% | 0.07 | 5.09% | 0.059 | 4.44%  |
|  HIV3U05 HIV-1 O Ab, high neg | 0.72 | 160 | 0.016 | 2.15% | 0.012 | 1.61% | 0.005 | 0.69% | 0.04 | 5.28% | 0.034 | 4.65%  |
|  HIV3U06 HIV-1 | 1.31 | 160 | 0.026 | 2.00% | 0.021 | 1.58% | 0.012 | 0.95% | 0.05 | 3.74% | 0.050 | 3.79%  |

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The Diagnostic Specialist

LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT

|  O Ab, low pos |  |  |  |  |  |  |  |  |  |  |  |  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  HIV3U07 HIV p24 Ag, high neg | 0.80 | 160 | 0.019 | 2.39% | 0.005 | 0.59% | 0.015 | 1.89% | 0.09 | 11.1% | 0.068 | 8.43% |   |
|  HIV3U08 HIV p24 Ag, low pos | 1.30 | 160 | 0.025 | 1.93% | 0.021 | 1.62% | 0.015 | 1.17% | 0.14 | 10.6% | 0.104 | 8.00% |   |
|  HIV3U09 HIV-1 M Ab, pos | 3.31 | 160 | 0.079 | 2.39% | 0.042 | 1.28% | 0.081 | 2.46% | 0.80 | 24.2% | 0.581 | 17.6% |   |
|  HIV3U10 HIV-2 Ab, pos | 2.32 | 160 | 0.038 | 1.63% | 0.022 | 0.97% | 0.049 | 2.11% | 0.16 | 6.94% | 0.131 | 5.66% |   |
|  HIV3U11 HIV-1 O Ab, pos | 2.48 | 160 | 0.043 | 1.72% | 0.032 | 1.29% | 0.024 | 0.95% | 0.12 | 4.94% | 0.105 | 4.21% |   |
|  HIV3U12 HIV p24 Ag, pos | 2.49 | 160 | 0.050 | 1.99% | 0.022 | 0.90% | 0.022 | 0.86% | 0.28 | 11.3% | 0.207 | 8.32% |   |

### 5. Reproducibility (5 day precision)

A five (5) day reproducibility study was performed at three (3) clinical sites, one (1) internal and two (2) external. Coded precision panel members, which included one (1) lot of LIAISON® MUREX Control HIV Ab/Ag HT as additional panel members, were tested in one (1) run per day on one (1) LIAISON® XS with six (6) replicates per run at each clinical testing site. Each serum sample panel member (excluding controls) was thawed and tested at each site which had at least two (2) unique operators performing the testing within the five (5) day study. The liquid controls were allowed to reach room temperature prior to use and stored at 2-8°C after each use, per the IFU. The assay was validated each day prior to testing by one replicate of each control generating results within the Certificate of Analysis (COA) range.

The study demonstrated comparable reproducibility on the LIAISON® XS compared to the LIAISON® XL.

Reproducibility

|  Sample ID | mean | Repeatability (Within Precision) |   | Between Days/Run |   | Within-Site (Laboratory) Precision |   | Between Sites |   | Reproducibility  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  (S/CO) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV  |
|  Positive Control HIV Ag (#71330036) | 2.39 | 0.036 | 1.5% | 0.027 | 1.1% | 0.045 | 1.9% | 0.076 | 3.2% | 0.088 | 3.7%  |
|  Positive Control anti-HIV-1M (#71340036) | 1.91 | 0.039 | 2.0% | 0.029 | 1.5% | 0.048 | 2.5% | 0.064 | 3.4% | 0.080 | 4.2%  |
|  Positive Control anti-HIV-1O (#71350036) | 2.70 | 0.054 | 2.0% | 0.032 | 1.2% | 0.063 | 2.3% | 0.082 | 3.1% | 0.104 | 3.8%  |
|  Positive Control anti-HIV-2 (#71360036) | 3.28 | 0.061 | 1.9% | 0.021 | 0.6% | 0.065 | 2.0% | 0.069 | 2.1% | 0.095 | 2.9%  |
|  Negative Control (#71370036) | 0.200 | 0.011 | 5.5% | 0.005 | 2.6% | 0.012 | 6.1% | 0.009 | 4.6% | 0.015 | 7.6%  |
|  HIV3U01 (anti-HIV-1M), high neg | 0.759 | 0.019 | 2.4% | 0.016 | 2.1% | 0.024 | 3.2% | 0.021 | 2.8% | 0.032 | 4.3%  |
|  HIV3U02 (anti-HIV-1M), low pos | 1.36 | 0.029 | 2.2% | 0.025 | 1.8% | 0.038 | 2.8% | 0.046 | 3.4% | 0.060 | 4.4%  |
|  HIV3U03 (anti-HIV-2), high neg | 0.848 | 0.020 | 2.4% | 0.020 | 2.3% | 0.028 | 3.3% | 0.028 | 3.2% | 0.039 | 4.7%  |

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LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT

|  HIV3U04 (anti-HIV-2), low pos | 1.34 | 0.037 | 2.7% | 0.026 | 1.9% | 0.045 | 3.3% | 0.054 | 4.1% | 0.070 | 5.3%  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  HIV3U05 (anti-HIV-1O), high neg | 0.718 | 0.015 | 2.1% | 0.012 | 1.6% | 0.019 | 2.6% | 0.018 | 2.5% | 0.026 | 3.6%  |
|  HIV3U06 (anti-HIV-1O), low pos | 1.30 | 0.035 | 2.7% | 0.023 | 1.8% | 0.042 | 3.2% | 0.041 | 3.1% | 0.058 | 4.5%  |
|  HIV3U07 (p24 Antigen), high neg | 0.758 | 0.016 | 2.1% | 0.021 | 2.7% | 0.026 | 3.4% | 0.016 | 2.0% | 0.030 | 4.0%  |
|  HIV3U08 (p24 Antigen), low pos | 1.223 | 0.023 | 1.8% | 0.009 | 0.8% | 0.024 | 2.0% | 0.032 | 2.6% | 0.041 | 3.3%  |
|  HIV3U09 (anti-HIV-1M), pos | 2.78 | 0.058 | 2.1% | 0.110 | 4.0% | 0.125 | 4.5% | 0.071 | 2.6% | 0.144 | 5.2%  |
|  HIV3U10 (anti-HIV-2), pos | 2.345 | 0.053 | 2.3% | 0.034 | 1.4% | 0.063 | 2.7% | 0.128 | 5.5% | 0.143 | 6.1%  |
|  HIV3U11 (anti-HIV-1O), pos | 2.43 | 0.059 | 2.4% | 0.062 | 2.6% | 0.086 | 3.5% | 0.059 | 2.4% | 0.104 | 4.3%  |
|  HIV3U12 (p24 Antigen), pos | 2.37 | 0.046 | 2.0% | 0.044 | 1.9% | 0.064 | 2.7% | 0.054 | 2.3% | 0.083 | 3.5%  |

## 6. Calibration Stability

A calibration stability study was performed to confirm the performance claim for the new platform.

Calibration stability study was run on one (1) LIAISON® XS Analyzer with one (1) LIAISON® MUREX HIV Ab/Ag HT (318290) integral lot. The integrals were placed on-board the instrument and kept in the reagent area for 36 days, one day more than the calibration stability declared in the IFU (five weeks).

All control results were within their defined ranges up to 36 days: 35 days (as stated in the IFU) plus one day. The linear regression for average percentage difference from T₀ for all samples was within the ±10% limit for the duration of the study - 36 days. Thus, these results confirmed the current IFU claim of calibration stability of 35 days, as stated in the IFU

## 7. Carryover

The carryover study was carried out to determine whether analyte carryover is present in the LIAISON® MUREX HIV AB/Ag HT US (318290) assay when run on the LIAISON® XS analyzer.

The test was split into two stages, Stage A and Stage B. Both stages were performed on:

- one (1) lot of LIAISON® XL MUREX HIV AB/Ag HT US (318290);
- one (1) lot of LIAISON® XL MUREX Control HIV AB/Ag HT US (318291);
- and on one (1) LIAISON® XS Analyzer.

There is no carryover/cross-contamination observable. The percentage of negative results for the negative sample was 100% for both Stages A and B. The percentage difference between the mean signal (RLU) values of all aliquots in Stage B and Stage A was -0.69%.

## 8. Additional centrifugation step for sample re-testing

A centrifugation step for all samples that are initially reactive was added to the sample processing steps to reduce the incidence of incorrectly repeatedly reactive samples for the LIAISON MUREX HIV Ab/Ag HT assay. With this extra step, samples requiring repeat testing will be centrifuged at 10,000xg for 10 minutes in a separate tube.

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**Diasorin**^{}[] The Diagnostic Specialist

LIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT---

This validation study was performed on the LIAISON® XS and on the LIAISON® XL analyzers using a total of 95 positive samples of the four HIV subtypes (anti-HIV-1 group O, anti-HIV-1 group M, anti-HIV-2, and p24 antigen) in serum and plasma that were run on the LIAISON® XL, including eight samples at the cut-off. All initially reactive samples were split into two aliquots; one aliquot was centrifuged for 10 minutes at 10,000x g and the other aliquot was not centrifuged. The two aliquots of each sample were then tested in duplicate. The average S/CO value of each centrifuged sample was analyzed against the average S/CO value of each non-centrifuged sample, and the initial screening results.

The acceptance criteria were that all samples should maintain their initial classification and the S/CO value of the centrifuged samples should not be significantly different from the S/CO value of both the initial result and of the non-centrifuged duplicate aliquot.

The results were acceptable. All samples that were initially reactive maintained their classification after centrifugation. There was no statistically significant difference between initial, non-centrifuged, and centrifuged samples in plasma. There appeared to be a statistically significant difference between initial and non-centrifuged/centrifuged in serum; however no significant difference was observed between non-centrifuged and centrifuged samples.

#### 9. Interfering Substances

Details of this study can be found in the original PMA BP190437.

#### 10. Sample Matrix

Details of this study can be found in the original PMA BP190437.

#### 11. Sample Handling

Details of this study can be found in the original PMA BP190437.

#### 12. Clinical Performance Evaluation

Details of this study can be found in the original PMA BP190437.

### TESTING SUMMARY

Testing and method comparison are complete, the predefined acceptance criteria were met, and data supported the equivalence of the LIAISON® MUREX HIV Ab/Ag HT US on both the LIAISON® XS and the LIAISON® XL platforms.

As the LIAISON® MUREX HIV Ab/Ag HT assay reagents and intended use population have not changed, additional clinical studies were not performed. Non-clinical studies were used to evaluate the performance of the new LIAISON® XS analyzer.

The nonclinical performance testing and method comparison study support a conclusion of substantial equivalence between the LIAISON® MUREX HIV Ab/Ag HT on the candidate (LIAISON® XS) and predicate (LIAISON® XL) analyzers.

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---

**Source:** [https://fda.innolitics.com/device/BK241116](https://fda.innolitics.com/device/BK241116)

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