Sample quality control includes sample collection, processing, preservation (consumables) quality control, sample sensory index and sample delivery quality control. Among them, the quality control of sample collection, treatment and preservation (consumables) is to ensure that the chemical pollution introduced in the above process can be controlled, and the objects are urine cups, urinary tubes, 15ml centrifuge tubes, EP tubes, meconium tubes, meconium spoons, related test reagents, etc. Sample sensory index quality control is the quality control of samples before bank, and the quality control is carried out by non-destructive operation of samples by sensory traits, such as serum/plasma volume (reflecting blood collection quality and sub-packaging quality), hemolysis/blood separation (whether pretreatment is timely and proper), etc. It can prompt the sample quality of each center, realize routine test and timely feedback, and standardize the operation process before bank. Sample delivery quality control requires the process of sample delivery, sub-packaging and remaining samples returning to the bank through specifications, so as to ensure the quality of birth cohort samples.
1. Sampling test
1）The specialist for original (routine) consumable material control needs to conduct random sampling test on each consumable in each batch of consumables according to the principle of random sampling test before the consumable distribution.
2）When the on-site (routine) on-site staff process samples, they select consumables according to the sample type, and each consumable in each batch of consumables shall be sampled according to the principle of random sampling (3 for each consumable).
3）On-site + storage (reserve) When processing samples, on-site staff shall select consumables according to sample types, and each consumable in each batch of consumables shall be sampled according to the principle of random sampling (3 for each consumable).
2. Computer test
The consumable material control specialist shall, within 24 hours after receiving the original consumables, on-site consumables and on-site + storage consumables in each batch of consumables, carry out computer test according to the actual sample test method, and check the dissolved content of common organic substances (such as phthalate esters and bisphenol A) in consumables by ultra-high performance liquid chromatography tandem mass spectrometry/gas chromatography tandem mass spectrometry and inorganic substances (such as calcium and lead) by inductively coupled plasma mass spectrometry. All test results need to be recorded completely.
1. Sampling
The bank quality control specialist needs to check the numbers in the bank form as a whole: whether there are duplicate codes; Whether there is a missing or one more digit in the number print.
In order to ensure representativeness and speed up bank, random sampling shall be carried out according to the principle of 5%.
After screening 5% sampling numbers, mark them in the bank table, and finally sort out the bank quality control sampling table.
2. Bank quality test
The bank quality control specialist shall verify the inventory of the transferred refrigerator.
Check whether the label falls off from the overall appearance. If it is missing, it is necessary to make up the label and find out the reason for falling off.
Sampling samples should be checked from such indexes as sample volume, hemolysis degree, label falling off, tube cover loosening, cryopreservation tube damage and sample number.
All sampling test shall be completed in the refrigerator at -20℃, and the temperature shall be monitored by thermometer in the whole process. Samples shall be placed on ice bags [26]. If the temperature is higher than -15℃, close the freezer cover to cool down and stop sampling test.
In order to ensure the quality of biological samples in the birth cohort, the sample delivery should strictly follow the standard operating procedures, as shown in Chapter 4 for details. The quality control of sample delivery is mainly carried out from three aspects: delivery, sub-packaging and re-bank.
1. Sample delivery
Before samples are delivered out of the bank, they must comply with the sample delivery specifications of the birth cohort, submit the delivery application, and then deliver the samples after approval, and record all sample delivery information in the system.
After the samples are delivered out of the bank, the specialist shall check the delivery application, the type and quantity of the delivery samples, sample 5% of the delivery samples, and check whether the coding information and delivery records of the delivery samples are accurate.
2. Sample sub-packaging
After the samples are delivered out of the bank to the samples are repackaged, the whole process of video recording can be used for quality control. The delivery quality control specialist regularly checks the video recording of repackaging, mainly for quality control of whether the laboratory environment is clean and sanitary, the dress of sample repackaging personnel, and the repackaging operation.
After the sample sub-packaging, the quality control specialist will randomly check 5% of the samples, and check the records of sample code, sample volume, label shedding and hemolysis degree.
The remaining samples are returned to the bank
When the remaining samples are returned to the bank, check whether the records such as sample code, delivery time, room temperature storage time, remaining sample volume and freeze-thaw times are accurate, and record all sample return information in the system.
