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IFU Hemaology

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External Quality Assessment (EQA)

Hematology – Monthly Program


Ref 444 Pack Size 12 x 2 ml

Instructions for Use Limitations


The usual precautions in the laboratory for potential 1) This product should not be used past the expiration date.
hazardous samples apply for these samples. The blood 2) This product is not intended for use as a standard.
donations used for production were tested to be non- 3) After mixing, the sample should be similar in appearance
reactive for HBsAg, anti-HIV 1/2 and anti-HCV. to fresh whole blood. In unmixed tubes, the supernatant
may appear cloudy and reddish. This is normal and does
Intended Use not indicate deterioration. Other discoloration, very dark
The NHS-NEQAS Hematology (Monthly) Program is red supernatant or unacceptable results may indicate
specifically designed to offer an independent and deterioration. Do not use the sample if deterioration is
confidential assessment of individual laboratory suspected.
performance. It also facilitates a comparative analysis of 4) The performance of this product is assured only if it is
the methods employed by various participating properly stored and used as described in the insert.
laboratories 5) Incomplete mixing of a tube prior to use invalidates both
the sample withdrawn and any remaining material in the
Product Description tube.
This product contains human erythrocytes, leukocytes,
platelets and preservatives suspended in EQA Sample. Reporting Information
The program entails a monthly presentation of results
Storage and Stability obtained for each analyte from the analysis of samples with
This product will be stable until the expiration date when unknown concentrations. While entering the results, please
stored unopened at 2 to 8°C. Once opened and stored select the appropriate instrument, method, and reagent from
tightly capped at 2 to 8°C, this product will be stable for 48 the drop-down menu. If any of them is not listed, contact us,
hours. and we will guide you. Ensure the accuracy of all reporting
codes by reviewing the online result form; results cannot be
Exception: changed once submitted.
 Protect tubes from OVERHEATING and FREEZING.
 This product is shipped under refrigerated conditions. Timing of Assays
Each sample result online submission date is updated in the
Detailed testing instructions: calendar on the nhs-neqas.com website. There are twelve
Before testing, it's essential to open the vial carefully by samples to be assayed over a twelve- month period, with one
removing the cap. The EQA Sample should be treated the sample every month.
same as patient specimen and run in accordance with the
instructions accompanying the instrument, kit and Deadline for Data Submission
reagent being used. Please check nhs-neqas.com website for further information
regarding the date of result submission.
Gloves should be put on before opening the container and
should be kept on throughout the period specimens are Reports and Certificates:
handled. Replace gloves if contaminated, or if their ability The data will be evaluated by NHS-NEQAS, and individual
to function as a barrier is compromised. laboratory reports can be retrieved online via our website. The
report of every round will be available within two days after
Ensure that the specimens reach room temperature deadline of result submission.
before testing. Gently invert the vials 4-5 times to ensure
homogeneity, without the use of a mechanical mixer. Roll Confidentiality:
the tube back and forth for 30 seconds (without shaking) We highly value participant confidentiality. Each laboratory is
until the red cells are completely suspended. uniquely identified by a code known only to NHS-NEQAS and
the participant. Results from sample analysis should not be
Transfer the specimen to a sample cup by inverting the disclosed to colleagues from other laboratories before the
vial. After sampling, promptly replace the cap and return testing period concludes.
the specimen vials to the refrigerator within 30 minutes of
use. It's vital to guarantee minimal exposure to room
temperature.

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External Quality Assessment (EQA)
Hematology – Monthly Program
Ref 444 Pack Size 12 x 2 ml

The samples are intended for use as quantitative control material for External Quality Assessment (EQA) in medical
laboratories for the following analytes:

 Haematocrit (HCT)  Haemoglobin (Hb)  Mean Cell Haemoglobin (MCH)


 Mean Cell Haemoglobin
 Mean Cell Volume (MCV)  Mean Platelet Volume (MPV)
Concentration (MCHC)
 Red Blood Cell Distribution Width
 Platelets (PLT)  Red Blood Cell Count (RBC)
(RDW)
 Total White Blood Cell Count
 Plateletcrit (PCT)
(WBC)

Warning
This product contains biological source material and should be treated as potentially infectious. Each human donor unit
used in its manufacturing has been rigorously tested for evidence of infection due to Human Immunodeficiency Virus (HIV),
Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV), with non-reactive or negative results. However, it may contain other
human source materials for which there are no approved tests. Therefore, it should be handled with the same precautions
used with patient specimens, following good laboratory practice.

Novative Healthtech Solutions (Pvt) Ltd


R & D lab, Ground floor, Atta ur Rahman school of applied biosciences,
NUST, Islamabad, Pakistan
Telephone: 051-90856109
Email: info@nhs-neqas.com
Website: nhs-neqas.com
Reference No: NHS/QC/Clinical/IFU/444

Handle as Biohazard Material

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