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What are the rejection criteria used in the lab?

Ans: 

VIRAL LOAD REJECTION CRITERIA FOR DBS SAMPLES

  • All Dry Blood spots on the card when less than the required size i.e. not filling the perforated area
  • Blood spots collected onto dirty/ soiled DBS card, compromising the specimen integrity.
  • DBS card with presence of serum rings i.e. improper drying (affecting the specimen integrity)
  • DBS card without ART and form number details (DBS card cannot be linked to request form)
  • DBS sample older than 3 weeks, VL test can’t be done on samples older than 3 weeks.
  • DBS sample sent on none perforated card (not able to get the right spot size during sample processing)
  • Dry Blood sample sent with less than 2 spots on the card filled
  • Patient’s dispatch form sent without patient’s identifications (ART number or Other number)
  • Mismatching ART number between the sample and form
  • Patient on ARVs for less than 6 months (doesn’t qualify for the Viral Load testing as per Algorithm)
  • Patient not yet initiated on ART (doesn’t qualify for the Viral Load testing as per Algorithm)
  • Patient with wrong date of treatment initiation i.e. date is beyond the current calendar date.
  • Patient with wrong date of treatment initiation i.e. date earlier than ART roll out.
  • Patient’s date of treatment initiation not included on the form thus failing to determine VL testing eligibility
  • Patient’s last viral load results given in less than 6 months
  • Sample not received at CPHL Lab (only the request form was received at the testing lab)
  • DBS sample being wet and having moulds thus compromising the sample integrity.
  • Two forms sent for the same sample (only dispatched results for one form)
  • Well labeled DBS card without any blood spots
  • Patient Viral Load results less than 1000cp/ml or Not Detected in less than 12 months. (Refer to testing Algorithm)
  • Patient Viral Load results above 1000cp/ml in less than 6 months. (Refer to testing Algorithm)
  • ART Number details shared by different patients from the same facility.
  • Wrong sample type sent to CPHL laboratories, Only Plasma and Dried Blood Spots (DBS) are required.

VIRAL LOAD REJECTION CRITERIA FOR PLASMA SAMPLES

  • Specimen sent to CPHL  laboratories with less than 0.75ml
  • Specimen sent to CPHL  laboratories haemolysed
  • Sample sent in a wrong container thus compromising the sample integrity. (use EDTA)
  • Sample delivered under wrong storage container thus compromising the sample integrity
  • Sample sent in a damaged container
  • Plasma sample container without ART and form number details (sample cannot be linked to request form)
  • Patient’s dispatch form sent without patient’s identifications (ART number or Other number)
  • Mismatching ART number between the sample and form
  • Patient on ARVs for less than 6 months (doesn’t qualify for the Viral Load testing as per Algorithm)
  • Patient not yet initiated on ART (doesn’t qualify for the Viral Load testing as per Algorithm)
  • Patient with wrong date of treatment initiation i.e. date is beyond the current calendar date.
  • Patient with wrong date of treatment initiation i.e. date earlier than ART roll out.
  • Patient’s date of treatment initiation not included on the form thus failing to determine VL testing eligibility
  • Patient’s last viral load results given in less than 6 months
  • Sample not received at CPHL Lab (only the request form was received at the testing lab)
  • Two forms sent for the same sample (only dispatched results for one form)
  • Well labelled cryovial container without any sample in it was sent to CPHL Lab.
  • Patient Viral Load results less than 1000cp/ml or Not Detected in less than 12 months (Refer to testing Algorithm)
  • Patient Viral Load results above 1000cp/ml in less than 6 months (Refer to testing Algorithm)
  • ART Number details shared by different patients from the same facility.
  • Wrong sample type sent to CPHL laboratories, Only Plasma and Dried Blood Spots (DBS) are required.

EID sample rejection criteria.

  • DBS card with traces of blood clots which will affect the sample integrity.
  • Sample sent with traces of serum rings due to improper drying and packaging
  • Sample with insufficient blood spots < 1/3 of a circle.
  • Dried Blood Spots collected onto a dirty DBS card (test requires clean card)
  • Infant above 18 months of age (right age is between 1.5 to 18 months old).
  • Mismatching ID/ Name between the sample and the form.
  • DBS card with scratched Dried Blood Spots (contaminated card)
  • Infant details written twice on the dispatch form. Results for one detail will be issued out.
  • DBS card sent to CPHL without any infant details(sample cannot be linked to request form)
  • DBS card sent to CPHL without any blood spot on it.
  • DBS sample not received at CPHL.
  • DBS card sent with overlapping blood spots (compromising the test integrity).
  • DBS sample packed and sent wet and having moulds (EID requires dried blood spots).
  • Sample sent for VL testing using a wrong requisition form.
  • Sample over stayed at the facility for more than 3 months (EID test requires dried fresh samples)
  • Sample sent without Infant’s age details (age is very important for EID test)