WHO Internal Use Only
Application Number:
Manufacturer identifier number:
Product name:
Date received at DLT:
  1. Manufacturer Information

1.1.  Manufacturer

1.1.1.  Name of manufacturer
1.1.2.  WHO manufacturer identification number (MMM) /
1.1.3.  Manufacturer physical address / Street Name and No.:
City:
Postcode:
Country:
1.1.4.  Manufacturer postal address / Street Name and No.:
Postal Office Box No.:
City:
Postcode:
Country:
1.1.5.  Manufacturer telephone
1.1.6.  Manufacturer fax
1.1.7.  Manufacturer email
1.1.8.  Manufacturer URL/web address
1.1.9.  Name of parent company

1.2.  Authorized contacts for the manufacturer[1]

1.2.1.  Name of key authorized contact
1.2.2.  Authorized contact postal address / Department:
Street Name and No.:
City:
Postcode:
Country:
1.2.3.  Authorized contact telephone / Fixed line:
Mobile/Cell phone:
1.2.4.  Authorized contact fax
1.2.5.  Authorized contact email
1.2.6.  Name of second authorized contact
1.2.7.  Authorized contact postal address / Department:
Street Name and No.:
City:
Postcode:
Country:
1.2.8.  Authorized contact telephone / Fixed line:
Mobile/Cell phone:
1.2.9.  Authorized contact fax
1.2.10.  Authorized contact email
  1. Product - Information

2.1.  Product name and product/catalogue number

2.1.1.  Product name
2.1.2.  Provide the product/catalogue number for each product kit size
Product/Catalogue number / Product kit size (number of tests)
2.1.3.  If reagents are supplied in more than one box, provide the name or identifier, catalogue/product number, and number of tests for each box of reagents
Name or identifier of reagent box / Product/Catalogue number / Reagent box size (number of tests)

2.2.  Current instructions-for-use[2]

2.2.1.  Instructions-for-use document number(s) /
2.2.2.  Instructions-for-use version number /
2.2.3.  Instructions-for-use release date /
2.2.4.  List languages available for the Instructions-for-use /

2.3.  Current user manual for CD4 Technologies[3]

2.3.1.  User manual document number /
2.3.2.  User manual version number /
2.3.3.  User manual release date /
2.3.4.  List languages available for the user manual /

2.4.  Storage temperature and shelf-life

2.4.1.  List storage temperature and shelf-life
Product name
If reagents are supplied in more than one box, provide the name or identifier for each reagent box / Storage temperature range (min °C - max °C) / Shelf-life upon manufacture
2.4.2.  Describe any other storage conditions that are applicable to this product
2.4.3.  Does a stability testing protocol exist for this product / Yes / No / Provide Document Number/s
  1. Product - Disease Category, Analyte and Method

3.1.  HIV

3.1.1.  Select HIV type / HIV-1/HIV-2 □
HIV-1 □
HIV-2 □
3.1.2.  Select HIV analyte / Antibody □
Antigen □
Ab/Ag combination □
Nucleic acid - qualitative □
Nucleic acid - quantitative □
Surrogate marker for viral load □

3.2.  Malaria

3.2.1.  Select malaria species / P. falciparum □
P. vivax □
P. ovale □
P. malariae □
Pan - all malarial species □
3.2.2.  Select malarial analyte / HRP2 □
pLDH □
Aldolase □
Multiple analytes □
Specify: ______

3.3.  Hepatitis C virus

3.3.1.  Select HCV analyte / Antibody □
Antigen □
Ab/Ag combination □

3.4.  Hepatitis B virus

3.4.1.  Hepatitis B virus surface antigen (HBsAg) □

3.5.  Assay format

3.5.1.  Select the assay format
Imunochromatographic (lateral flow) □
Immunofiltration (flow through) □
Agglutination □
EIA (Enzyme Immunoassay) in microtitre plate format □
Recombinant Immunoblot □
Western Blot □
Antigen Neutralization □
Immunofluorescence □
Other: ______ □
NAT (nucleic acid testing) □
NAT methodology: ______

3.6.  CD4 counting technology[4]

3.6.1.  Select the best description of the CD4 instrument/method. / Double platform flow cytometer □
Single platform flow cytometer □
Microchip □
Point-of-care □
Others (specify):
3.6.2.  If the instrument is a flow cytometer select the appropriate description. / Volumetric □
Bead based □
Others (specify):
3.6.3.  Select the appropriate electricity power requirement / Alternating current (110-220V) □
Direct current (battery) □
3.6.4.  Select the lysing method / Lyse and wash □
Lyse no wash □
No lyse no wash □
3.6.5.  Does the assay require dedicated monoclonal antibodies (also called closed system) / Yes □
No □
3.6.6.  Indicate the approximate price of / Instrument ______USD
Cost per test ______USD
3.6.7.  Select the type of results obtained / CD 4 counts only □
CD4 percent only □
CD4 counts and percent □
CD4 counts and hematology □
CD4 percent and hematology □
CD4 counts, percent and hematology □
CD4 counts semiquantitative □
CD4 percent semiquantitative □
CD4 counts semiquantitative □
CD4 counts, percentage semiquantitative □
  1. Product - Operation

4.1.  Assay controls

4.1.1.  Do the Instructions-for-use include instructions on whether or not to accept the results of the assay? / Yes / No
4.1.2.  Does the assay include reagent-addition controls? / Yes / No
4.1.3.  Does the assay include specimen-addition controls? / Yes / No
4.1.4.  Does the assay include any other type of controls? / Specify:
4.1.5.  Are control samples (also called test-kit controls) supplied with the assay? / Yes / No
4.1.6.  Are control samples, specific for this product, available separately? / Yes / No

4.2.  Product usage

4.2.1.  How long does it take to obtain a test result with this product (include time taken for specimen manipulation steps)? / ______hrs, ______mins
4.2.2.  How long does the test result remain stable to allow for reading of the result? / ______hrs, ______mins
4.2.3.  State the minimum number of specimens that can be tested in a single run
4.2.4.  State the maximum number of specimens that can be tested in a single run

4.3.  Instrumentation

4.3.1.  Does this product require instrumentation?
4.3.2.  List all required instrumentation. / Yes / No
Provided by the manufacturer:
Not provided by the manufacturer:
4.3.3.  Does this product require a dedicated analyzer (also called a closed system)?
4.3.4.  Provide the name of the dedicated analyzer and the name of the manufacturer of the dedicated analyzer. / Yes / No
4.3.5.  Does the instrument require daily calibration? / Yes / No
4.3.6.  Does the instrument require daily running of controls? / Yes / No
4.3.7.  Select the technology throughput per day. / 0-20 tests/day □
20-50 tests/day □
50-100 tests/day □
> 100 tests/day □

4.4.  CD4 Technologies[5]

4.4.1.  Indicate the type of testing kits available for lymphocyte subset / Testing kit Storage temperature
enumeration and indicate the required storage temperature.
  1. Product - Performance

5.1.  Specifications

5.1.1.  Provide the manufacturer's performance specifications for this product / Sensitivity %
confidence interval %
Specificity %
confidence interval %

5.2.  Specifications for CD4 Technologies[6]

5.2.1.  Provide the manufacturer's performance specifications for this product / Analytical range / CD4 counts ______
CD4% ______

5.3.  Specifications for Virological technologies[7]

5.3.1.  Provide the manufacturer's performance specifications for this product / Sensitivity %
confidence interval %
Specificity %
confidence interval %
Dynamic range

5.4.  Independent performance evaluations[8]

5.4.1.  Provide details of independent performance evaluations carried out for this product in the last five years
Name of Independent Evaluation Centre / Physical Address of Independent Evaluation Centre / Date of Evaluation (Year)
  1. Product Commercial and Regulatory Status

6.1.  Regulatory status of product

6.1.1.  Provide details of all current regulatory approvals for this product
(Do not include ISO 13485:2003 certification details here. This is covered in question 8)
Name of Regulatory Authority / Type of Regulatory Approval / Period of Approval
Start (DD/MM/YY) -
Expiry (DD/MM/YY)

6.2.  Commercial agreements

6.2.1.  List all commercial arrangements which permit the manufacture or supply of this product under the same name or a different name
(Include "original manufacturer" products, "re-branded" products, and any other agreements that permit the manufacture or supply of this product under the same or a different name).

6.3.  WHO history of product

6.3.1.  Has WHO previously been requested to evaluate or prequalify this product? / Yes / No / Date (Year)
6.3.2.  Has WHO previously evaluated or prequalified this product / Yes / No / Date (Year)
6.3.3.  Has WHO previously evaluated or prequalified this product under a different name?
6.3.4.  Provide the name of the previously evaluated or prequalified product / Yes / No / Date (Year)
  1. Manufacturer - Quality Management System

7.1.1.  Does the manufacturer have a quality management system in place for the manufacture of this product? / Yes / No
7.1.2.  Does this quality management system meet the requirements of ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes? / Yes / No
7.1.3.  Does the manufacturer hold a copy of the document ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes? / Yes / No
7.1.4.  Does the manufacturer have a documented procedure in place, relevant to this product, for the control of design and development changes? / Yes / No / Provide Document Number/s
7.1.5.  Does the manufacturer have a documented procedure in place, relevant to this product, for the provision of advisory notices to customers, subsequent to product delivery, in all countries of supply? / Yes / No / Provide Document Number/s
7.1.6.  Does the manufacturer have a documented procedure in place for corrective and preventative action for non-conformities relating to this product? / Yes / No / Provide Document Number/s
  1. Manufacturer - ISO 13485:2003 Certification

8.1.1.  If the manufacturer holds "ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes" certification for the manufacture of this product, then provide details of this certification here
Name of Certification Body / Period of Certification
Start (Year) - Expiry (Year)
  1. Manufacturer - Sites of Product Manufacture

9.1.  Sites of manufacture

9.1.1.  List all sites that are involved in the manufacture of this product. Include all stages of manufacture (for example, design, production, warehousing, quality control, and release for supply)
Name of Site / Physical Address of Site / Description of the stage of manufacture

9.2.  Key Suppliers

9.2.1.  List all key suppliers which supply products/components/services for the manufacture of this product
Name of Supplier / Physical Address of Supplier / Description of the component/product/service
supplied
  1. Manufacturer Declaration

The undersigned key authorized representative of the Manufacturer makes the following declarations on behalf of the Manufacturer and, in signing this application form, declares that he/she has the authority to bind the Manufacturer.

I declare that:

·  I am authorized to represent the manufacturer specified in this prequalification application form (the "Manufacturer") for the purposes of WHO diagnostics prequalification of the product specified in this application form (the "Product").

·  all the information provided in this form is current and correct.

·  the Product is a commercially available diagnostic product.

·  the Manufacturer understands and agrees that, in the event that WHO agrees to undertake prequalification assessment of the Product: (i) WHO will have absolute unfettered control over the manner in which the prequalification assessment is carried out, including the publication of the results of the prequalification assessment, regardless of the outcome; and (ii) the Manufacturer will pay WHO's fee for the diagnostics prequalification assessment.

·  the Manufacturer understands that the purpose of this prequalification is to provide advice to the governments of WHO Member States and undertakes not to use the outcome of the prequalification, including, in particular, the WHO name and/or emblem, for commercial and/or promotional purposes.

Name of the Key Authorized Contact Person for the Manufacturer:______

Signature of the Key Authorized Contact Person for the Manufacturer:______

Date: ______

PQDx_015 v3 02 February 2010 Page 8 of 19

[1] [ATTACHMENT: Attach a signed letter from the manufacturer stating that the above two people are authorized to represent the manufacturer for the purposes of prequalification.]

[2] [ATTACHMENT: Attach the English language version of the instructions-for-use to this application form. Instructions -for-use are also known as a package insert.]

[3] [Section 2.3. applies only to CD4 technologies and should be left blank for other types of products.]

[4] [Section 3.6. applies only to CD4 technologies and should be left blank for other types of products.]

[5] [Section 4.4. applies only to CD4 technologies and should be left blank for other types of products.]

[6] [Section 5.2. applies only to CD4 Technologies and should be left blank for other types of products.]

[7] [Section 5.3. applies only to Virological Technologies and should be left blank for other types of products.]

[8] [ATTACHMENT: Attach pdf files of peer reviewed published papers/conference abstracts from independently conducted studies.]